System / system
shared term, no equivalence asserted
The rows below print this term in 4 jurisdictions, set side by side by each row’s own jurisdiction field, in code-unit order of that field. Each definition is kept apart under its own text, and quoted where the term and its text together sit under the quote cap: 0 of 2 definitions in this view are quoted and 2 are withheld with the reason. No reading here says that two of them agree or differ.
EU
- Defined in
- EU MDR
chapter-i/article-2(11): text withheld (over the cap: its term and text are 25 words) - Rows printing it in a normative sentence
- 36
- Rows printing it in a title
- 1
- Rows printing it in body
- 31
International
- Defined in
- ICH Q13no clause given: text withheld (over the cap: its term and text are 28 words)
- Rows printing it in a normative sentence
- 5
- Rows printing it in a title
- 3
- Rows printing it in body
- 9
UK
- Defined in
- no current text of a row of this jurisdiction defines it
- Rows printing it in a normative sentence
- 0
- Rows printing it in a title
- 0
- Rows printing it in body
- 2
US
- Defined in
- no current text of a row of this jurisdiction defines it
- Rows printing it in a normative sentence
- 9
- Rows printing it in a title
- 4
- Rows printing it in body
- 15
These forms are printed by the
tracked documents, each as a document defines it. The index’s key is
system (the definitions derivation’s fold:
case set aside, spaces collapsed; each form is matched exactly as printed).
3 observed texts define it.
Counts below are over each row’s current text, the
81 of 126 current
texts the derivation read; a title is read for every one of the 132 tracked rows.
Defined
2 definitions in 2 current texts, as the definitions derivation’s rules read them, quoted where the term and its text together sit under the quote cap.
- EU MDR
EUtext first observedchapter-i/article-2(11)system: text withheld (over the cap: its term and text are 25 words)
- ICH Q13
Internationaltext first observed- no clause given (its definitions section's heading carries no number the clause anchors placed) System: text withheld (over the cap: its term and text are 28 words)
In normative sentences
1392 sentences in 50 current texts
printing one of the forms in the heading and one of the sentence derivation’s listed verbs (shall, should, must, is expected, may). A sentence is a row of printed words; nothing here calls it a requirement. A defining occurrence that lies inside such a sentence is counted here and under Defined; only In body leaves out both.
Each sentence is given by the clause the sentence derivation places it under and the verbs it prints, grouped by clause, each clause followed by its count of sentences; its words are not quoted here, and are served by their offsets at /api/v1/modal-sentences.json.
- Annex 11 concept paper
EU16 sentences; text first observed1: 16 sentences (should, must, may) - EMA CT computerised systems
EU108 sentences; text first observedid repeats in this text: 1 sentence (should) · follows a withheld heading: 37 sentences (should, may) · id repeats in this text: 70 sentences (should, may) - EMA data quality framework
EU4 sentences; text first observed10: 4 sentences (should, may) - EU AI Act
EU302 sentences; text first observedno clause anchor before this sentence: 102 sentences (should, may, must) ·chapter-i/article-3: 1 sentence (may, shall) ·chapter-ii/article-5/1: 1 sentence (shall) ·chapter-ii/article-5/2: 2 sentences (shall) ·chapter-ii/article-5/3: 4 sentences (shall, may) ·chapter-ii/article-5/4: 1 sentence (shall) ·chapter-iii/section-1/article-6/1: 1 sentence (shall) ·chapter-iii/section-1/article-6/3: 3 sentences (shall) ·chapter-iii/section-1/article-6/4: 1 sentence (shall) ·chapter-iii/section-1/article-7/2: 1 sentence (shall, may) ·chapter-iii/section-2/article-8/1: 1 sentence (shall) ·chapter-iii/section-2/article-8/2: 1 sentence (shall) ·chapter-iii/section-2/article-9/1: 1 sentence (shall) ·chapter-iii/section-2/article-9/2: 2 sentences (shall, may) ·chapter-iii/section-2/article-9/3: 1 sentence (shall, may) ·chapter-iii/section-2/article-9/5: 2 sentences (shall) ·chapter-iii/section-2/article-9/8: 1 sentence (shall) ·chapter-iii/section-2/article-9/9: 1 sentence (shall) ·chapter-iii/section-2/article-10/2: 1 sentence (shall) ·chapter-iii/section-2/article-10/3: 1 sentence (shall) ·chapter-iii/section-2/article-10/4: 1 sentence (shall) ·chapter-iii/section-2/article-11/1: 2 sentences (shall) ·chapter-iii/section-2/article-11/2: 1 sentence (shall) ·chapter-iii/section-2/article-12/1: 1 sentence (shall) ·chapter-iii/section-2/article-12/2: 1 sentence (shall, may) ·chapter-iii/section-2/article-12/3: 1 sentence (shall) ·chapter-iii/section-2/article-13/1: 1 sentence (shall) ·chapter-iii/section-2/article-13/3: 1 sentence (shall, may) ·chapter-iii/section-2/article-14/2: 1 sentence (shall, may) ·chapter-iii/section-2/article-14/3: 1 sentence (shall) ·chapter-iii/section-2/article-14/4: 1 sentence (shall) ·chapter-iii/section-2/article-14/5: 1 sentence (shall) ·chapter-iii/section-2/article-15/4: 1 sentence (shall, may) ·chapter-iii/section-2/article-15/5: 1 sentence (shall) ·chapter-iii/section-3/article-16: 1 sentence (shall) ·chapter-iii/section-3/article-17/1: 2 sentences (shall) ·chapter-iii/section-3/article-17/4: 1 sentence (shall) ·chapter-iii/section-3/article-18/1: 1 sentence (shall) ·chapter-iii/section-3/article-19/1: 1 sentence (shall) ·chapter-iii/section-3/article-20/1: 2 sentences (shall) ·chapter-iii/section-3/article-20/2: 1 sentence (shall) ·chapter-iii/section-3/article-21/1: 1 sentence (shall) ·chapter-iii/section-3/article-21/2: 1 sentence (shall) ·chapter-iii/section-3/article-22/3: 1 sentence (shall) ·chapter-iii/section-3/article-23/1: 1 sentence (shall) ·chapter-iii/section-3/article-23/2: 2 sentences (shall) ·chapter-iii/section-3/article-23/3: 1 sentence (shall) ·chapter-iii/section-3/article-23/4: 1 sentence (shall) ·chapter-iii/section-3/article-23/5: 1 sentence (shall) ·chapter-iii/section-3/article-23/6: 1 sentence (shall) ·chapter-iii/section-3/article-23/7: 1 sentence (shall) ·chapter-iii/section-3/article-24/1: 1 sentence (shall) ·chapter-iii/section-3/article-24/2: 2 sentences (shall) ·chapter-iii/section-3/article-24/3: 1 sentence (shall) ·chapter-iii/section-3/article-24/4: 2 sentences (shall) ·chapter-iii/section-3/article-24/5: 1 sentence (shall) ·chapter-iii/section-3/article-24/6: 1 sentence (shall) ·chapter-iii/section-3/article-25/1: 1 sentence (shall) ·chapter-iii/section-3/article-25/2: 2 sentences (shall) ·chapter-iii/section-3/article-25/3: 1 sentence (shall) ·chapter-iii/section-3/article-25/4: 1 sentence (shall) ·chapter-iii/section-3/article-26/4: 1 sentence (shall) ·chapter-iii/section-3/article-26/5: 2 sentences (shall, may) ·chapter-iii/section-3/article-26/6: 1 sentence (shall) ·chapter-iii/section-3/article-26/7: 1 sentence (shall) ·chapter-iii/section-3/article-26/8: 1 sentence (shall) ·chapter-iii/section-3/article-26/10: 3 sentences (shall) ·chapter-iii/section-3/article-26/11: 1 sentence (shall) ·chapter-iii/section-3/article-26/12: 1 sentence (shall) ·chapter-iii/section-3/article-27/1: 2 sentences (shall, may) ·chapter-iii/section-3/article-27/2: 1 sentence (shall) ·chapter-iii/section-4/article-31/4: 1 sentence (shall) ·chapter-iii/section-4/article-31/8: 1 sentence (shall) ·chapter-iii/section-4/article-34/2: 2 sentences (shall) ·chapter-iii/section-4/article-36/8: 1 sentence (shall) ·chapter-iii/section-4/article-36/9: 2 sentences (shall, may) ·chapter-iii/section-5/article-40/2: 1 sentence (shall) ·chapter-iii/section-5/article-43/1: 3 sentences (shall) ·chapter-iii/section-5/article-43/4: 2 sentences (shall) ·chapter-iii/section-5/article-44/3: 1 sentence (shall) ·chapter-iii/section-5/article-45/1: 1 sentence (shall) ·chapter-iii/section-5/article-45/2: 1 sentence (shall) ·chapter-iii/section-5/article-46/2: 2 sentences (may, shall) ·chapter-iii/section-5/article-46/3: 1 sentence (shall) ·chapter-iii/section-5/article-46/5: 1 sentence (shall) ·chapter-iii/section-5/article-47/1: 2 sentences (shall) ·chapter-iii/section-5/article-47/2: 2 sentences (shall) ·chapter-iii/section-5/article-47/3: 1 sentence (shall) ·chapter-iii/section-5/article-48/2: 1 sentence (shall) ·chapter-iii/section-5/article-48/3: 1 sentence (shall) ·chapter-iii/section-5/article-48/4: 1 sentence (shall) ·chapter-iii/section-5/article-48/5: 1 sentence (shall) ·chapter-iii/section-5/article-49/1: 1 sentence (shall) ·chapter-iii/section-5/article-49/2: 1 sentence (shall) ·chapter-iii/section-5/article-49/3: 1 sentence (shall) ·chapter-iv/article-50/1: 1 sentence (shall) ·chapter-iv/article-50/2: 1 sentence (shall) ·chapter-iv/article-50/3: 1 sentence (shall) ·chapter-iv/article-50/4: 2 sentences (shall) ·chapter-vi/article-57/7: 1 sentence (shall) ·chapter-vi/article-57/12: 1 sentence (shall) ·chapter-vi/article-58/2: 1 sentence (shall, may) ·chapter-vi/article-59/1: 1 sentence (may, shall) ·chapter-vi/article-60/2: 1 sentence (may) ·chapter-vi/article-60/4: 1 sentence (may, shall) ·chapter-vi/article-60/7: 1 sentence (shall) ·chapter-vi/article-61/1: 1 sentence (shall, may) ·chapter-vi/article-63/1: 2 sentences (may, shall) ·chapter-vii/section-2/article-70/8: 1 sentence (shall) ·chapter-viii/article-71/5: 1 sentence (shall) ·chapter-ix/section-1/article-72/1: 1 sentence (shall) ·chapter-ix/section-1/article-72/2: 1 sentence (shall, may) ·chapter-ix/section-1/article-72/3: 1 sentence (shall) ·chapter-ix/section-1/article-72/4: 1 sentence (shall) ·chapter-ix/section-2/article-73/2: 1 sentence (shall) ·chapter-ix/section-2/article-73/4: 1 sentence (shall) ·chapter-ix/section-2/article-73/6: 2 sentences (shall, may) ·chapter-ix/section-3/article-74/6: 1 sentence (shall) ·chapter-ix/section-3/article-74/13: 1 sentence (shall) ·chapter-ix/section-3/article-75/1: 1 sentence (shall) ·chapter-ix/section-3/article-75/3: 2 sentences (may, shall) ·chapter-ix/section-3/article-76/5: 1 sentence (shall) ·chapter-ix/section-3/article-77/3: 1 sentence (may) ·chapter-ix/section-3/article-79/2: 2 sentences (shall, may) ·chapter-ix/section-3/article-79/5: 1 sentence (shall) ·chapter-ix/section-3/article-79/6: 2 sentences (shall) ·chapter-ix/section-3/article-79/7: 1 sentence (shall) ·chapter-ix/section-3/article-79/9: 1 sentence (shall) ·chapter-ix/section-3/article-80/1: 1 sentence (shall) ·chapter-ix/section-3/article-80/2: 1 sentence (shall, may) ·chapter-ix/section-3/article-80/3: 1 sentence (shall) ·chapter-ix/section-3/article-80/4: 2 sentences (shall) ·chapter-ix/section-3/article-80/6: 1 sentence (shall) ·chapter-ix/section-3/article-80/7: 1 sentence (shall) ·chapter-ix/section-3/article-81/2: 1 sentence (shall) ·chapter-ix/section-3/article-81/3: 1 sentence (shall) ·chapter-ix/section-3/article-82/1: 1 sentence (shall, may) ·chapter-ix/section-3/article-82/3: 1 sentence (shall) ·chapter-ix/section-3/article-83/2: 1 sentence (shall) ·chapter-ix/section-4/article-86/1: 1 sentence (shall) ·chapter-x/article-96/1: 1 sentence (shall) ·chapter-xii/article-99/7: 1 sentence (shall) ·chapter-xii/article-99/9: 1 sentence (may) ·chapter-xii/article-100/1: 1 sentence (shall) ·chapter-xii/article-100/3: 1 sentence (shall) ·chapter-xiii/article-111/1: 1 sentence (shall) ·chapter-xiii/article-112/2: 1 sentence (shall) ·annex-iv: 1 sentence (shall) ·annex-vii/2: 2 sentences (shall) ·annex-vii/3.1: 1 sentence (shall) ·annex-vii/3.2: 2 sentences (shall) ·annex-vii/3.3: 1 sentence (shall) ·annex-vii/3.4: 2 sentences (shall) ·annex-vii/4.1: 1 sentence (shall) ·annex-vii/4.4: 1 sentence (may) ·annex-vii/4.5: 1 sentence (shall) ·annex-vii/4.6: 5 sentences (shall) ·annex-vii/4.7: 1 sentence (shall) ·annex-vii/5.3: 1 sentence (shall) ·annex-xii: 1 sentence (shall) - EU Cyber Resilience Act
EU33 sentences; text first observedno clause anchor before this sentence: 11 sentences (should, may) ·chapter-i/article-3: 1 sentence (may) ·chapter-iv/article-43/2: 1 sentence (shall) ·chapter-v/article-57/1: 1 sentence (shall) ·chapter-vii/article-64/6: 1 sentence (shall) ·chapter-vii/article-64/8: 1 sentence (may) ·annex-vii: 1 sentence (shall) ·annex-viii/part-iv/2: 1 sentence (shall) ·annex-viii/part-iv/3.1: 2 sentences (shall) ·annex-viii/part-iv/3.2: 3 sentences (shall) ·annex-viii/part-iv/3.3: 2 sentences (shall) ·annex-viii/part-iv/3.4: 1 sentence (shall) ·annex-viii/part-iv/3.5: 2 sentences (shall) ·annex-viii/part-iv/4.2: 1 sentence (shall) ·annex-viii/part-iv/4.3: 1 sentence (shall) ·annex-viii/part-iv/6: 1 sentence (shall) ·annex-viii/part-iv/7: 2 sentences (shall) - EU Cybersecurity Act
EU4 sentences; text first observedno clause anchor before this sentence: 4 sentences (should, may) - Regulation (EU) 2026/1744
EU45 sentences; text first observedno clause anchor before this sentence: 21 sentences (should, may) ·article-1: 1 sentence (shall, may) ·article-1/3: 4 sentences (shall) ·article-1/4: 1 sentence (shall) ·article-1/5: 4 sentences (shall) ·article-1/6: 13 sentences (may, shall) ·article-1/8: 1 sentence (may) - EU GMP Annex 1
EU63 sentences; text first observedannex-1/11: 63 sentences (should, may) - EU GMP Annex 10
EU1 sentence; text first observed2: 1 sentence (should) - EU GMP Annex 11
EU22 sentences; text first observedno clause anchor before this sentence: 1 sentence (should) ·1: 2 sentences (should) ·2: 1 sentence (should) ·3.1: 1 sentence (must, should) ·3.4: 1 sentence (should) ·4.3: 1 sentence (should) ·4.4: 1 sentence (should) ·4.5: 1 sentence (should) ·4.6: 1 sentence (should) ·4.7: 1 sentence (should) ·4.8: 1 sentence (should) ·6: 1 sentence (should) ·9: 1 sentence (should) ·10: 1 sentence (should) ·12.1: 2 sentences (should, may) ·13: 1 sentence (should) ·15: 1 sentence (should) ·16: 2 sentences (should) ·17: 1 sentence (should) - EU GMP Annex 11 (draft)
EU60 sentences; text first observed17: 57 sentences (should, may) ·17.1: 1 sentence (may) ·17.2: 1 sentence (should) ·17.5: 1 sentence (may) - EU GMP Annex 12
EU1 sentence; text first observedno clause anchor before this sentence: 1 sentence (may) - EU GMP Annex 13
EU7 sentences; text first observed2: 2 sentences (should, may) ·2.1: 1 sentence (should) ·7: 2 sentences (may, should) ·8: 2 sentences (should) - EU GMP Annex 14
EU8 sentences; text first observed10: 8 sentences (must, should, may) - EU GMP Annex 15
EU8 sentences; text first observedno clause anchor before this sentence: 1 sentence (should) ·1.3: 1 sentence (should, may) ·1.5: 1 sentence (should) ·2.2: 1 sentence (should) ·3.1: 1 sentence (should) ·11.1: 1 sentence (should) ·11.4: 1 sentence (should) ·11.5: 1 sentence (should) - EU GMP Annex 16
EU5 sentences; text first observed1.5.5: 1 sentence (may) ·1.7: 1 sentence (should) ·1.10.2: 1 sentence (should) ·2: 1 sentence (may) ·2.2: 1 sentence (should) - EU GMP Annex 17
EU5 sentences; text first observed5: 5 sentences (should, may) - EU GMP Annex 2
EU9 sentences; text first observed5: 2 sentences (must) ·25: 1 sentence (should) ·36: 6 sentences (should, must) - EU GMP Annex 21
EU3 sentences; text first observed3.1: 1 sentence (should) ·4.2: 1 sentence (should) ·5.1.1: 1 sentence (should) - EU GMP Annex 22
EU5 sentences; text first observed10: 1 sentence (should) ·10.1: 2 sentences (should) ·10.3: 1 sentence (should) ·10.5: 1 sentence (may) - EU GMP Annex 3
EU4 sentences; text first observed3: 1 sentence (may) ·13: 1 sentence (should) ·46: 1 sentence (should) ·47: 1 sentence (should) - EU GMP Annex 6
EU3 sentences; text first observed15: 1 sentence (should) ·29: 1 sentence (should) ·40: 1 sentence (may, should) - EU GMP Annex 7
EU1 sentence; text first observed8: 1 sentence (should) - EU GMP Annex 8
EU2 sentences; text first observed3: 1 sentence (should) ·5: 1 sentence (should) - EU GMP Chapter 1
EU10 sentences; text first observedchapter-1: 10 sentences (should) - EU GMP Chapter 2
EU5 sentences; text first observedpart-1: 5 sentences (should) - EU GMP Chapter 3
EU1 sentence; text first observedpart-1: 1 sentence (should) - EU GMP Chapter 4
EU7 sentences; text first observedno numbering read: 7 sentences (should, must, may) - EU GMP Chapter 4 (draft)
EU27 sentences; text first observedno numbering read: 27 sentences (should, must, may) - EU GMP Chapter 5
EU1 sentence; text first observedpart-1: 1 sentence (should) - EU GMP Chapter 7
EU2 sentences; text first observedno numbering read: 2 sentences (must, should) - EU GMP Chapter 8
EU2 sentences; text first observedpart-1: 2 sentences (should) - EU IVDR
EU178 sentences; text first observedno clause anchor before this sentence: 18 sentences (should, may) ·chapter-i/section-1/article-2: 1 sentence (shall, may) ·chapter-ii/article-8/1: 1 sentence (shall) ·chapter-ii/article-10/2: 1 sentence (shall) ·chapter-ii/article-10/6: 1 sentence (shall) ·chapter-ii/article-10/8: 3 sentences (shall) ·chapter-ii/article-10/9: 1 sentence (shall) ·chapter-ii/article-10/12: 1 sentence (shall) ·chapter-ii/article-13/4: 1 sentence (shall) ·chapter-ii/article-15/3: 1 sentence (shall) ·chapter-ii/article-16/3: 2 sentences (shall) ·chapter-ii/article-16/4: 1 sentence (shall) ·chapter-iii/article-24/1: 1 sentence (shall) ·chapter-iii/article-24/2: 3 sentences (shall) ·chapter-iii/article-24/11: 1 sentence (may) ·chapter-iii/article-24/12: 1 sentence (shall) ·chapter-iii/article-27/1: 1 sentence (shall) ·chapter-iii/article-27/3: 1 sentence (shall) ·chapter-iii/article-28/1: 2 sentences (shall) ·chapter-iii/article-28/2: 1 sentence (shall) ·chapter-iii/article-28/4: 1 sentence (shall) ·chapter-iii/article-28/7: 1 sentence (shall) ·chapter-iii/article-30/2: 1 sentence (shall) ·chapter-iv/article-36/2: 1 sentence (shall) ·chapter-iv/article-38/10: 1 sentence (shall) ·chapter-iv/article-39/2: 1 sentence (shall) ·chapter-iv/article-40/5: 1 sentence (shall) ·chapter-iv/article-40/12: 1 sentence (shall) ·chapter-iv/article-42/2: 1 sentence (shall) ·chapter-iv/article-42/6: 1 sentence (shall) ·chapter-iv/article-43/4: 1 sentence (shall) ·chapter-v/section-2/article-49/2: 1 sentence (shall) ·chapter-v/section-2/article-50/1: 1 sentence (shall) ·chapter-v/section-2/article-51/5: 1 sentence (shall) ·chapter-v/section-2/article-52: 1 sentence (shall) ·chapter-vi/article-59/2: 1 sentence (shall) ·chapter-vi/article-59/6: 1 sentence (shall) ·chapter-vi/article-65/2: 1 sentence (shall) ·chapter-vi/article-66/1: 1 sentence (shall) ·chapter-vi/article-66/2: 2 sentences (shall) ·chapter-vi/article-66/3: 1 sentence (shall) ·chapter-vi/article-69/1: 1 sentence (shall) ·chapter-vi/article-69/2: 1 sentence (shall) ·chapter-vi/article-69/5: 1 sentence (shall) ·chapter-vi/article-70/1: 1 sentence (shall) ·chapter-vi/article-71/1: 1 sentence (shall) ·chapter-vi/article-72/3: 1 sentence (shall) ·chapter-vi/article-72/4: 1 sentence (shall) ·chapter-vi/article-73/1: 1 sentence (shall) ·chapter-vi/article-73/5: 1 sentence (shall) ·chapter-vi/article-73/7: 2 sentences (shall) ·chapter-vi/article-74/1: 1 sentence (may) ·chapter-vi/article-74/8: 1 sentence (shall) ·chapter-vi/article-74/11: 1 sentence (shall) ·chapter-vi/article-74/12: 1 sentence (shall) ·chapter-vi/article-76/2: 1 sentence (shall) ·chapter-vi/article-76/3: 1 sentence (shall) ·chapter-vi/article-76/4: 1 sentence (shall) ·chapter-vi/article-77: 1 sentence (may) ·chapter-vii/section-1/article-78/1: 2 sentences (shall) ·chapter-vii/section-1/article-78/2: 1 sentence (shall) ·chapter-vii/section-1/article-78/3: 1 sentence (shall) ·chapter-vii/section-1/article-79: 1 sentence (shall) ·chapter-vii/section-1/article-81/2: 3 sentences (shall) ·chapter-vii/section-2/article-82/1: 1 sentence (shall) ·chapter-vii/section-2/article-83/1: 1 sentence (shall, may) ·chapter-vii/section-2/article-84/5: 1 sentence (shall) ·chapter-vii/section-2/article-84/7: 1 sentence (shall) ·chapter-vii/section-2/article-84/8: 1 sentence (shall) ·chapter-vii/section-2/article-84/9: 1 sentence (shall) ·chapter-vii/section-2/article-85: 1 sentence (shall, may) ·chapter-vii/section-2/article-87/1: 2 sentences (shall) ·chapter-vii/section-2/article-87/2: 1 sentence (shall) ·chapter-vii/section-2/article-87/3: 1 sentence (shall) ·chapter-vii/section-2/article-87/4: 1 sentence (may) ·chapter-vii/section-2/article-87/5: 1 sentence (shall) ·chapter-vii/section-2/article-87/6: 1 sentence (shall) ·chapter-vii/section-2/article-87/7: 1 sentence (shall) ·chapter-vii/section-2/article-87/8: 1 sentence (shall) ·chapter-vii/section-2/article-87/9: 1 sentence (shall) ·chapter-vii/section-3/article-88/4: 1 sentence (shall) ·chapter-vii/section-3/article-88/7: 1 sentence (shall) ·chapter-vii/section-3/article-88/8: 1 sentence (shall) ·chapter-vii/section-3/article-90/2: 1 sentence (shall) ·chapter-vii/section-3/article-90/4: 1 sentence (shall) ·chapter-vii/section-3/article-90/6: 2 sentences (shall) ·chapter-vii/section-3/article-92/2: 1 sentence (shall) ·chapter-vii/section-3/article-93/2: 1 sentence (shall) ·chapter-vii/section-3/article-94/4: 1 sentence (shall) ·chapter-vii/section-3/article-95/1: 1 sentence (shall) ·chapter-vii/section-3/article-95/2: 1 sentence (shall) ·chapter-viii/article-100/5: 1 sentence (shall) ·annex-i/chapter-i/3: 2 sentences (shall) ·annex-i/chapter-ii: 2 sentences (shall) ·annex-ii/1.1: 1 sentence (may) ·annex-ii/3.1: 1 sentence (shall) ·annex-ii/3.2: 1 sentence (shall) ·annex-vi/part-c/6.2.1: 1 sentence (shall) ·annex-vi/part-c/6.2.4: 1 sentence (shall) ·annex-vii/2.1: 1 sentence (shall) ·annex-vii/2.2: 1 sentence (shall) ·annex-vii/2.3: 1 sentence (shall) ·annex-vii/3.1.1: 1 sentence (shall) ·annex-vii/3.1.2: 1 sentence (shall) ·annex-vii/3.2.3: 1 sentence (shall) ·annex-vii/3.2.6: 1 sentence (shall) ·annex-vii/3.2.7: 1 sentence (shall) ·annex-vii/4.3: 1 sentence (shall) ·annex-vii/4.5.1: 1 sentence (shall) ·annex-vii/4.5.2: 2 sentences (shall) ·annex-vii/4.6: 1 sentence (shall) ·annex-vii/4.8: 1 sentence (shall) ·annex-vii/4.9: 2 sentences (shall) ·annex-vii/4.10: 1 sentence (shall) ·annex-ix/chapter-i/1: 2 sentences (shall) ·annex-ix/chapter-i/2.1: 2 sentences (shall) ·annex-ix/chapter-i/2.2: 4 sentences (shall) ·annex-ix/chapter-i/2.3: 5 sentences (shall) ·annex-ix/chapter-i/2.4: 3 sentences (shall) ·annex-ix/chapter-i/3.2: 1 sentence (shall) ·annex-ix/chapter-i/3.3: 2 sentences (shall) ·annex-ix/chapter-ii: 1 sentence (shall) ·annex-xi/1: 1 sentence (shall) ·annex-xi/3.1: 1 sentence (shall) ·annex-xi/3.2: 2 sentences (shall) ·annex-xi/3.3: 1 sentence (shall) ·annex-xii/chapter-i/3: 1 sentence (shall) ·annex-xii/chapter-i/4: 1 sentence (shall) ·annex-xii/chapter-i/5: 1 sentence (shall) ·annex-xii/chapter-i/7: 1 sentence (shall) ·annex-xiii/part-a/1.3.3: 1 sentence (shall) - EU Machinery Regulation
EU48 sentences; text first observedno clause anchor before this sentence: 4 sentences (should) ·chapter-i/article-3: 1 sentence (may) ·chapter-v/article-38/3: 1 sentence (shall) ·chapter-v/article-40/1: 1 sentence (shall) ·annex-iii/part-b/5: 19 sentences (shall, may, should) ·annex-iii/part-b/5.5: 1 sentence (shall) ·annex-iii/part-b/6.1.1: 1 sentence (shall) ·annex-iv/part-a: 1 sentence (shall) ·annex-iv/part-b: 1 sentence (shall) ·annex-ix/2: 1 sentence (shall) ·annex-ix/3.1: 2 sentences (shall) ·annex-ix/3.2: 3 sentences (shall) ·annex-ix/3.3: 2 sentences (shall) ·annex-ix/3.4: 1 sentence (shall) ·annex-ix/3.5: 2 sentences (shall) ·annex-ix/4.2: 1 sentence (shall) ·annex-ix/4.3: 1 sentence (shall) ·annex-ix/4.4: 1 sentence (may) ·annex-ix/6: 1 sentence (shall) ·annex-ix/7: 2 sentences (shall) ·annex-x/2: 1 sentence (shall) - EU MDR
EU191 sentences; text first observedno clause anchor before this sentence: 17 sentences (should, may) ·chapter-i/article-2: 1 sentence (shall, may) ·chapter-ii/article-8/1: 1 sentence (shall) ·chapter-ii/article-10/2: 1 sentence (shall) ·chapter-ii/article-10/7: 1 sentence (shall) ·chapter-ii/article-10/9: 3 sentences (shall) ·chapter-ii/article-10/10: 1 sentence (shall) ·chapter-ii/article-10/13: 1 sentence (shall) ·chapter-ii/article-13/4: 1 sentence (shall) ·chapter-ii/article-15/3: 1 sentence (shall) ·chapter-ii/article-16/3: 2 sentences (shall) ·chapter-ii/article-16/4: 1 sentence (shall) ·chapter-ii/article-17/3: 1 sentence (may) ·chapter-ii/article-22/1: 1 sentence (shall) ·chapter-ii/article-22/2: 1 sentence (shall) ·chapter-ii/article-22/4: 1 sentence (shall) ·chapter-ii/article-22/5: 1 sentence (shall) ·chapter-iii/article-27/1: 1 sentence (shall) ·chapter-iii/article-27/2: 3 sentences (shall) ·chapter-iii/article-27/11: 1 sentence (may, shall) ·chapter-iii/article-27/12: 1 sentence (shall) ·chapter-iii/article-29/2: 1 sentence (shall) ·chapter-iii/article-30/1: 1 sentence (shall) ·chapter-iii/article-30/3: 1 sentence (shall) ·chapter-iii/article-31/1: 2 sentences (shall) ·chapter-iii/article-31/2: 1 sentence (shall) ·chapter-iii/article-31/4: 1 sentence (shall) ·chapter-iii/article-31/7: 1 sentence (shall) ·chapter-iii/article-33/2: 1 sentence (shall) ·chapter-iii/article-33/8: 1 sentence (shall) ·chapter-iv/article-40/2: 1 sentence (shall) ·chapter-iv/article-42/10: 1 sentence (shall) ·chapter-iv/article-43/2: 1 sentence (shall) ·chapter-iv/article-44/5: 1 sentence (shall) ·chapter-iv/article-44/12: 1 sentence (shall) ·chapter-iv/article-46/2: 1 sentence (shall) ·chapter-iv/article-46/7: 1 sentence (shall) ·chapter-iv/article-47/4: 1 sentence (shall) ·chapter-v/section-2/article-53/2: 1 sentence (shall) ·chapter-v/section-2/article-54/3: 1 sentence (shall) ·chapter-v/section-2/article-55/1: 1 sentence (shall) ·chapter-v/section-2/article-56/5: 1 sentence (shall) ·chapter-v/section-2/article-57/1: 1 sentence (shall) ·chapter-v/section-2/article-57/2: 1 sentence (shall) ·chapter-vi/article-63/2: 1 sentence (shall) ·chapter-vi/article-63/6: 1 sentence (shall) ·chapter-vi/article-69/2: 1 sentence (shall) ·chapter-vi/article-70/1: 1 sentence (shall) ·chapter-vi/article-70/2: 2 sentences (shall) ·chapter-vi/article-70/3: 1 sentence (shall) ·chapter-vi/article-73/1: 1 sentence (shall) ·chapter-vi/article-73/2: 1 sentence (shall) ·chapter-vi/article-73/5: 1 sentence (shall) ·chapter-vi/article-74/1: 1 sentence (shall) ·chapter-vi/article-75/1: 1 sentence (shall) ·chapter-vi/article-76/3: 1 sentence (shall) ·chapter-vi/article-76/4: 1 sentence (shall) ·chapter-vi/article-77/1: 1 sentence (shall) ·chapter-vi/article-77/5: 1 sentence (shall) ·chapter-vi/article-77/7: 2 sentences (shall) ·chapter-vi/article-78/1: 1 sentence (may) ·chapter-vi/article-78/8: 1 sentence (shall) ·chapter-vi/article-78/11: 1 sentence (shall) ·chapter-vi/article-78/12: 1 sentence (shall) ·chapter-vi/article-80/2: 1 sentence (shall) ·chapter-vi/article-80/3: 1 sentence (shall) ·chapter-vi/article-80/4: 1 sentence (shall) ·chapter-vi/article-81: 1 sentence (may) ·chapter-vii/section-1/article-83/1: 2 sentences (shall) ·chapter-vii/section-1/article-83/2: 1 sentence (shall) ·chapter-vii/section-1/article-83/3: 1 sentence (shall) ·chapter-vii/section-1/article-84: 1 sentence (shall) ·chapter-vii/section-1/article-86/2: 3 sentences (shall) ·chapter-vii/section-2/article-87/1: 1 sentence (shall) ·chapter-vii/section-2/article-88/1: 1 sentence (shall, may) ·chapter-vii/section-2/article-89/5: 1 sentence (shall) ·chapter-vii/section-2/article-89/7: 1 sentence (shall) ·chapter-vii/section-2/article-89/8: 1 sentence (shall) ·chapter-vii/section-2/article-89/9: 1 sentence (shall) ·chapter-vii/section-2/article-90: 1 sentence (shall, may) ·chapter-vii/section-2/article-92/1: 2 sentences (shall) ·chapter-vii/section-2/article-92/2: 1 sentence (shall) ·chapter-vii/section-2/article-92/3: 1 sentence (shall) ·chapter-vii/section-2/article-92/4: 1 sentence (may) ·chapter-vii/section-2/article-92/5: 1 sentence (shall) ·chapter-vii/section-2/article-92/6: 1 sentence (shall) ·chapter-vii/section-2/article-92/7: 1 sentence (shall) ·chapter-vii/section-2/article-92/8: 1 sentence (shall) ·chapter-vii/section-2/article-92/9: 1 sentence (shall) ·chapter-vii/section-3/article-93/4: 1 sentence (shall) ·chapter-vii/section-3/article-93/7: 1 sentence (shall) ·chapter-vii/section-3/article-93/8: 1 sentence (shall) ·chapter-vii/section-3/article-95/2: 1 sentence (shall) ·chapter-vii/section-3/article-95/4: 1 sentence (shall) ·chapter-vii/section-3/article-95/6: 2 sentences (shall) ·chapter-vii/section-3/article-97/2: 1 sentence (shall) ·chapter-vii/section-3/article-98/2: 1 sentence (shall) ·chapter-vii/section-3/article-99/4: 1 sentence (shall) ·chapter-vii/section-3/article-100/1: 1 sentence (shall) ·chapter-vii/section-3/article-100/2: 1 sentence (shall) ·annex-i/chapter-i/3: 2 sentences (shall) ·annex-i/chapter-ii: 5 sentences (shall) ·annex-vi/part-a/2.1: 1 sentence (may) ·annex-vi/part-c/6.3.1: 1 sentence (shall) ·annex-vi/part-c/6.3.2: 2 sentences (shall) ·annex-vi/part-c/6.3.3: 1 sentence (shall) ·annex-vi/part-c/6.4.4: 1 sentence (shall) ·annex-vi/part-c/6.5.1: 1 sentence (shall) ·annex-vi/part-c/6.5.4: 1 sentence (shall) ·annex-vii/2.1: 1 sentence (shall) ·annex-vii/2.2: 1 sentence (shall) ·annex-vii/2.3: 1 sentence (shall) ·annex-vii/3.1.1: 1 sentence (shall) ·annex-vii/3.1.2: 1 sentence (shall) ·annex-vii/3.2.3: 1 sentence (shall) ·annex-vii/3.2.6: 1 sentence (shall) ·annex-vii/3.2.7: 1 sentence (shall) ·annex-vii/4.3: 1 sentence (shall) ·annex-vii/4.5.1: 1 sentence (shall) ·annex-vii/4.5.2: 2 sentences (shall) ·annex-vii/4.6: 1 sentence (shall) ·annex-vii/4.8: 1 sentence (shall) ·annex-vii/4.9: 2 sentences (shall) ·annex-vii/4.10: 1 sentence (shall) ·annex-ix/chapter-i/1: 2 sentences (shall) ·annex-ix/chapter-i/2.1: 2 sentences (shall) ·annex-ix/chapter-i/2.2: 4 sentences (shall) ·annex-ix/chapter-i/2.3: 5 sentences (shall) ·annex-ix/chapter-i/2.4: 3 sentences (shall) ·annex-ix/chapter-i/3.2: 1 sentence (shall) ·annex-ix/chapter-i/3.3: 2 sentences (shall) ·annex-ix/chapter-ii: 1 sentence (shall) ·annex-xi/part-a: 5 sentences (shall) ·annex-xi/part-b: 1 sentence (shall) ·annex-xii/chapter-i/3: 1 sentence (shall) ·annex-xii/chapter-i/4: 1 sentence (shall) ·annex-xii/chapter-i/5: 1 sentence (shall) ·annex-xii/chapter-i/7: 1 sentence (shall) - EU NIS2 Directive
EU13 sentences; text first observedno clause anchor before this sentence: 8 sentences (should, may) ·chapter-i/article-6: 1 sentence (may) ·chapter-ii/article-11/1: 1 sentence (shall) ·chapter-iv/article-21/2: 1 sentence (shall) ·chapter-v/article-26/5: 1 sentence (may) ·chapter-vii/article-34/8: 1 sentence (shall) - FDA AI guidance
US4 sentences; text first observed7: 4 sentences (must, may, should) - FDA device cybersecurity (2026)
US50 sentences; text first observed6: 50 sentences (must, should, may, is expected) - FDA electronic systems (clinical)
US28 sentences; text first observedno clause anchor before this sentence: 28 sentences (should, may, must) - FDA Part 11 scope
US3 sentences; text first observedno numbering read: 3 sentences (may, should) - ICH Q12
International12 sentences; text first observed4: 12 sentences (should, must, may) - ICH Q13
International22 sentences; text first observedfollows a withheld heading: 17 sentences (may, should) · id repeats in this text: 1 sentence (may) · follows a withheld heading: 4 sentences (should, may) - ICH Q14
International1 sentence; text first observed13.2: 1 sentence (should) - ICH Q9(R1)
International3 sentences; text first observed8: 3 sentences (should, may) - NIST AI 600-1
US18 sentences; text first observed3: 4 sentences (may) ·6: 1 sentence (may) ·9: 1 sentence (may) ·12: 12 sentences (may) - NIST AI RMF
International16 sentences; text first observed1.2.1: 1 sentence (may) ·1.2.3: 2 sentences (may, should) ·1.2.4: 2 sentences (may) ·3: 1 sentence (should) ·3.1: 1 sentence (should) ·3.4: 1 sentence (should) ·5: 1 sentence (should) ·5.2: 4 sentences (may, should, shall) ·6: 3 sentences (may) - NISTIR 8183
US7 sentences; text first observed7: 7 sentences (may, must, should) - 21 CFR Part 11
US6 sentences; text first observedno numbering read: 6 sentences (may, should, shall) - 21 CFR Part 211
US16 sentences; text first observedno numbering read: 16 sentences (shall, may, must) - 21 CFR Part 820 (QMSR)
US2 sentences; text first observedno numbering read: 2 sentences (must, shall)
In titles
8 tracked rows whose titles print one of the forms in the heading, read from the title this record holds, by the same exact rule.
- EudraLex Volume 4, Chapter 1 — Pharmaceutical Quality System
EU - Computer Software Assurance for Production and Quality Management System Software
US - Cybersecurity in Medical Devices — Quality System Considerations and Content of Premarket Submissions
US - Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions
US - ISO/IEC 42001 — Artificial intelligence management system
International - ISO/IEC 42005 — AI system impact assessment
International - PDA Technical Report No. 80 — Data Integrity Management System for Pharmaceutical Laboratories
International - 21 CFR Part 820 — Quality Management System Regulation
US
In body
1465 occurrences in 57 current texts outside every sentence above and outside the term’s own definitions, each counted under the clause anchor the clause-anchor derivation placed last before it; each clause is followed by its count.
- Annex 11 concept paper
EU4 occurrences; text first observed1: 3 ·8: 1 - EMA CT computerised systems
EU48 occurrences; text first observed48 where the heading before it is withheld - EMA data quality framework
EU18 occurrences; text first observed10: 16 ·20: 2 - Annex 15 revision concept paper
International1 occurrence; text first observed2: 1 - DI revision concept paper
International4 occurrences; text first observed4 where no numbering read in this text - EU AI Act
EU133 occurrences; text first observedannex-i/17: 1 ·annex-iv/1: 7 ·annex-iv/2: 11 ·annex-iv/3: 3 ·annex-iv/4: 1 ·annex-iv/5: 1 ·annex-iv/6: 1 ·annex-iv/9: 2 ·annex-ix/3: 2 ·annex-v/1: 2 ·annex-v/4: 1 ·annex-v/5: 2 ·annex-vi/2: 1 ·annex-vi/3: 1 ·annex-vi/4: 1 ·annex-vii: 1 ·annex-vii/1: 1 ·annex-vii/3: 1 ·annex-vii/4.6: 2 ·annex-vii/5: 1 ·annex-vii/5.1: 1 ·annex-viii/10: 1 ·annex-viii/13: 8 ·annex-viii/4: 2 ·annex-viii/5: 2 ·annex-viii/6: 1 ·annex-viii/7: 1 ·annex-x/1: 4 ·annex-x/2: 3 ·annex-x/4: 2 ·annex-x/5: 3 ·annex-x/6: 3 ·annex-xi/section-2/3: 1 ·chapter-i/article-2/1: 2 ·chapter-i/article-2/12: 1 ·chapter-iii/section-1/article-7/3: 1 ·chapter-iii/section-2/article-11/3: 1 ·chapter-iii/section-2/article-9: 1 ·chapter-iii/section-3/article-17: 1 ·chapter-iii/section-3/article-27/2: 1 ·chapter-xiii/article-113: 1 · 49 where no heading is read before it - EU Cyber Resilience Act
EU9 occurrences; text first observedannex-viii/part-iv/3: 1 ·annex-viii/part-iv/4.1: 1 ·chapter-i/article-7/2: 1 · 6 where no heading is read before it - EU Cybersecurity Act
EU5 occurrences; text first observedtitle-i/article-2: 3 · 2 where no heading is read before it - Regulation (EU) 2026/1744
EU24 occurrences; text first observedarticle-1/3: 8 ·article-1/5: 2 · 14 where no heading is read before it - EU GMP Annex 1
EU20 occurrences; text first observedannex-1/11: 19 ·annex-1/3: 1 - EU GMP Annex 10
EU2 occurrences; text first observed1: 1 ·4: 1 - EU GMP Annex 11
EU8 occurrences; text first observed12.2: 1 ·17: 6 · 1 where no heading is read before it - EU GMP Annex 11 (draft)
EU40 occurrences; text first observed17: 20 ·17.5: 18 ·3: 1 ·6: 1 - EU GMP Annex 13
EU2 occurrences; text first observed8: 1 · 1 where no heading is read before it - EU GMP Annex 14
EU2 occurrences; text first observed10: 2 - EU GMP Annex 15
EU5 occurrences; text first observed12: 4 ·3.11: 1 - EU GMP Annex 2
EU3 occurrences; text first observed36: 2 ·8: 1 - EU GMP Annex 21
EU1 occurrence; text first observed3: 1 - EU GMP Annex 22
EU1 occurrence; text first observed10.3: 1 - EU GMP Annex 3
EU2 occurrences; text first observed10: 1 ·2: 1 - EU GMP Annex 6
EU6 occurrences; text first observed13: 1 ·45: 5 - EU GMP Annex 7
EU1 occurrence; text first observed1 where no heading is read before it - EU GMP Annex 8
EU3 occurrences; text first observed3: 2 · 1 where no heading is read before it - EU GMP Chapter 1
EU9 occurrences; text first observedchapter-1: 9 - EU GMP Chapter 2
EU3 occurrences; text first observedpart-1: 3 - EU GMP Chapter 4
EU1 occurrence; text first observed1 where no numbering read in this text - EU GMP Chapter 4 (draft)
EU6 occurrences; text first observed6 where no numbering read in this text - EU GMP Chapter 6
EU1 occurrence; text first observedpart-1: 1 - EU GMP Chapter 7
EU1 occurrence; text first observed1 where no numbering read in this text - EU IVDR
EU19 occurrences; text first observedannex-ix/chapter-i/2: 1 ·annex-ix/chapter-i/3.1: 1 ·annex-vi/part-a/2.1: 1 ·annex-viii/2.2: 5 ·annex-xi/3: 1 ·chapter-i/section-1/article-2: 1 ·chapter-iii/article-24: 1 ·chapter-iii/article-27: 1 ·chapter-iii/article-27/1: 1 ·chapter-vi/article-69: 1 ·chapter-vii/section-1/article-78: 1 ·chapter-vii/section-2/article-87: 1 ·chapter-vii/section-3/article-95: 1 ·chapter-x/article-113/3: 2 - EU Machinery Regulation
EU4 occurrences; text first observedannex-ix/3: 1 ·annex-ix/4.1: 1 ·chapter-i/article-6/5: 2 - EU MDR
EU27 occurrences; text first observedannex-ii/1.1: 1 ·annex-ix/chapter-i/2: 1 ·annex-ix/chapter-i/3.1: 1 ·annex-vi/part-a/2.1: 1 ·annex-viii/chapter-i/2: 2 ·annex-viii/chapter-iii: 10 ·annex-xi/part-a: 1 ·chapter-iii/article-27: 1 ·chapter-iii/article-30: 1 ·chapter-iii/article-30/1: 1 ·chapter-v/section-2/article-57: 1 ·chapter-vi/article-73: 1 ·chapter-vii/section-1/article-83: 1 ·chapter-vii/section-2/article-92: 1 ·chapter-vii/section-3/article-100: 1 ·chapter-x/article-123/3: 2 - EU NIS2 Directive
EU12 occurrences; text first observedannex-i/1: 6 ·annex-i/11: 1 ·chapter-i/article-2/2: 1 · 4 where no heading is read before it - FDA AI guidance
US4 occurrences; text first observed7: 4 - FDA AI device list
US285 occurrences; text first observed285 where no numbering read in this text - FDA CSA
US5 occurrences; text first observed5 where no numbering read in this text - FDA device cybersecurity
US3 occurrences; text first observed3 where no numbering read in this text - FDA device cybersecurity (2026)
US87 occurrences; text first observed6: 84 · 3 where no heading is read before it - FDA electronic systems (clinical)
US21 occurrences; text first observed21 where no heading is read before it - FDA/EMA AI principles
International4 occurrences; text first observed4 where no numbering read in this text - FDA guidance agenda
US2 occurrences; text first observed2 where no numbering read in this text - FDA Part 11 scope
US11 occurrences; text first observed11 where no numbering read in this text - ICH Q12
International13 occurrences; text first observed4: 13 - ICH Q13
International54 occurrences; text first observed54 where the heading before it is withheld - ICH Q14
International17 occurrences; text first observed13.2: 15 · 2 where the heading before it is withheld - ICH Q2(R2)
International8 occurrences; text first observedannex-2/1.2: 1 ·annex-2/2: 1 ·annex-2/4: 5 ·annex-2/5: 1 - ICH Q9(R1)
International23 occurrences; text first observed25: 10 ·8: 13 - MHRA AI Airlock
UK1 occurrence; text first observed1 where no numbering read in this text - MHRA data integrity
UK2 occurrences; text first observed2 where no numbering read in this text - NIST agent standards
US1 occurrence; text first observed1 where no numbering read in this text - NIST AI 600-1
US120 occurrences; text first observed12: 117 ·3: 2 ·7: 1 - NIST AI RMF
International86 occurrences; text first observed1.1: 1 ·1.2.1: 2 ·1.2.3: 2 ·3: 4 ·3.1: 4 ·3.3: 1 ·3.4: 5 ·3.5: 8 ·3.6: 1 ·3.7: 1 ·4: 1 ·5.1: 4 ·5.2: 11 ·5.3: 10 ·5.4: 3 ·6: 19 · 9 where no heading is read before it - NIST SP 800-82
US2 occurrences; text first observed2 where no numbering read in this text - NISTIR 8183
US278 occurrences; text first observed6: 1 ·7: 276 · 1 where no heading is read before it - 21 CFR Part 11
US4 occurrences; text first observed4 where no numbering read in this text - 21 CFR Part 211
US1 occurrence; text first observed1 where no numbering read in this text - 21 CFR Part 820 (QMSR)
US8 occurrences; text first observed8 where no numbering read in this text
Co-occurrence
293 other terms of the index share at least one clause of a current text with this one: a clause a definition sits in, the clause of a sentence above, or the clause a body occurrence is counted under. Terms in order of their key; each with the count of clauses shared and the clauses, by row. 968 positions of this term have no placed clause and share none (a defining occurrence inside a sentence above is counted once under each).
- accessory for a medical device 1 clause:
eu-mdrchapter-i/article-2 - accessory for an in vitro diagnostic medical device 1 clause:
eu-ivdrchapter-i/section-1/article-2 - accreditation 5 clauses:
eu-ai-actchapter-xiii/article-113;eu-cybersecurity-acttitle-i/article-2;eu-ivdrchapter-x/article-113/3;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-x/article-123/3 - Act 4 clauses:
eu-ai-actchapter-xiii/article-113;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124 - active device 3 clauses:
eu-mdrannex-viii/chapter-i/2·annex-viii/chapter-iii·chapter-i/article-2 - Active device intended for diagnosis and monitoring 1 clause:
eu-mdrannex-viii/chapter-i/2 - Active therapeutic device 1 clause:
eu-mdrannex-viii/chapter-i/2 - actively exploited vulnerability 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - adverse event 9 clauses:
ema-data-quality-framework10;eu-gmp-annex-1410;eu-gmp-annex-236;eu-gmp-chapter-8part-1;eu-ivdrchapter-i/section-1/article-2·chapter-vi/article-76/2;eu-mdrchapter-i/article-2·chapter-vi/article-80/2;nist-ai-rmf3.3 - Agency 9 clauses:
ema-data-quality-framework10;eu-ai-actchapter-xiii/article-113;eu-gmp-annex-1410;eu-mdrchapter-x/article-123/3;eu-nis2annex-i/11;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;nist-ai-600-112 - agglomerate 1 clause:
eu-mdrchapter-i/article-2 - aggregate 2 clauses:
eu-mdrchapter-i/article-2;nist-ai-600-112 - AI literacy 3 clauses:
eu-ai-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1·article-1/3 - AI Office 7 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-25/4·chapter-ix/section-3/article-75/1·chapter-ix/section-3/article-75/3;eu-digital-omnibus-aiarticle-1/5·article-1/6·article-1/8 - AI regulatory sandbox 6 clauses:
eu-ai-actchapter-i/article-3·chapter-vi/article-57/12·chapter-vi/article-57/7·chapter-vi/article-58/2·chapter-vi/article-59/1;eu-digital-omnibus-aiarticle-1/6 - AI system 176 clauses:
eu-ai-actannex-iv·annex-iv/1·annex-iv/2·annex-iv/3·annex-iv/4·annex-iv/9·annex-ix/3·annex-v/1·annex-v/4·annex-v/5·annex-vi/3·annex-vi/4·annex-vii/2·annex-vii/3.1·annex-vii/4.1·annex-vii/4.4·annex-vii/4.5·annex-vii/4.6·annex-vii/4.7·annex-viii/10·annex-viii/13·annex-viii/4·annex-viii/5·annex-viii/7·annex-xii·chapter-i/article-2/1·chapter-i/article-2/12·chapter-i/article-3·chapter-ii/article-5/1·chapter-iii/section-1/article-6/1·chapter-iii/section-1/article-6/3·chapter-iii/section-1/article-6/4·chapter-iii/section-1/article-7/2·chapter-iii/section-1/article-7/3·chapter-iii/section-2/article-10/2·chapter-iii/section-2/article-10/3·chapter-iii/section-2/article-10/4·chapter-iii/section-2/article-11/1·chapter-iii/section-2/article-11/2·chapter-iii/section-2/article-12/2·chapter-iii/section-2/article-13/3·chapter-iii/section-2/article-14/2·chapter-iii/section-2/article-14/3·chapter-iii/section-2/article-14/4·chapter-iii/section-2/article-8/2·chapter-iii/section-2/article-9/2·chapter-iii/section-2/article-9/3·chapter-iii/section-2/article-9/5·chapter-iii/section-2/article-9/8·chapter-iii/section-2/article-9/9·chapter-iii/section-3/article-16·chapter-iii/section-3/article-17/1·chapter-iii/section-3/article-18/1·chapter-iii/section-3/article-19/1·chapter-iii/section-3/article-20/1·chapter-iii/section-3/article-20/2·chapter-iii/section-3/article-21/1·chapter-iii/section-3/article-21/2·chapter-iii/section-3/article-22/3·chapter-iii/section-3/article-23/1·chapter-iii/section-3/article-23/2·chapter-iii/section-3/article-23/3·chapter-iii/section-3/article-23/4·chapter-iii/section-3/article-23/5·chapter-iii/section-3/article-23/6·chapter-iii/section-3/article-23/7·chapter-iii/section-3/article-24/1·chapter-iii/section-3/article-24/2·chapter-iii/section-3/article-24/3·chapter-iii/section-3/article-24/4·chapter-iii/section-3/article-24/5·chapter-iii/section-3/article-24/6·chapter-iii/section-3/article-25/1·chapter-iii/section-3/article-25/2·chapter-iii/section-3/article-25/3·chapter-iii/section-3/article-25/4·chapter-iii/section-3/article-26/10·chapter-iii/section-3/article-26/11·chapter-iii/section-3/article-26/12·chapter-iii/section-3/article-26/4·chapter-iii/section-3/article-26/5·chapter-iii/section-3/article-26/6·chapter-iii/section-3/article-26/7·chapter-iii/section-3/article-26/8·chapter-iii/section-3/article-27/1·chapter-iii/section-3/article-27/2·chapter-iii/section-4/article-31/4·chapter-iii/section-4/article-31/8·chapter-iii/section-4/article-34/2·chapter-iii/section-4/article-36/9·chapter-iii/section-5/article-40/2·chapter-iii/section-5/article-43/1·chapter-iii/section-5/article-43/4·chapter-iii/section-5/article-44/3·chapter-iii/section-5/article-46/2·chapter-iii/section-5/article-46/3·chapter-iii/section-5/article-47/1·chapter-iii/section-5/article-47/2·chapter-iii/section-5/article-47/3·chapter-iii/section-5/article-48/3·chapter-iii/section-5/article-48/4·chapter-iii/section-5/article-48/5·chapter-iii/section-5/article-49/1·chapter-iii/section-5/article-49/2·chapter-iii/section-5/article-49/3·chapter-iv/article-50/1·chapter-iv/article-50/2·chapter-iv/article-50/4·chapter-ix/section-1/article-72/1·chapter-ix/section-2/article-73/2·chapter-ix/section-2/article-73/4·chapter-ix/section-2/article-73/6·chapter-ix/section-3/article-74/13·chapter-ix/section-3/article-74/6·chapter-ix/section-3/article-75/1·chapter-ix/section-3/article-75/3·chapter-ix/section-3/article-76/5·chapter-ix/section-3/article-77/3·chapter-ix/section-3/article-79/2·chapter-ix/section-3/article-79/5·chapter-ix/section-3/article-79/6·chapter-ix/section-3/article-79/7·chapter-ix/section-3/article-79/9·chapter-ix/section-3/article-80/1·chapter-ix/section-3/article-80/2·chapter-ix/section-3/article-80/3·chapter-ix/section-3/article-80/4·chapter-ix/section-3/article-80/6·chapter-ix/section-3/article-80/7·chapter-ix/section-3/article-81/2·chapter-ix/section-3/article-81/3·chapter-ix/section-3/article-82/1·chapter-ix/section-3/article-82/3·chapter-ix/section-3/article-83/2·chapter-ix/section-4/article-86/1·chapter-vi/article-57/12·chapter-vi/article-57/7·chapter-vi/article-58/2·chapter-vi/article-59/1·chapter-vi/article-60/2·chapter-vi/article-60/4·chapter-vi/article-60/7·chapter-vi/article-61/1·chapter-vii/section-2/article-70/8·chapter-x/article-96/1·chapter-xii/article-100/1·chapter-xii/article-100/3·chapter-xii/article-99/7;eu-digital-omnibus-aiarticle-1·article-1/3·article-1/4·article-1/5·article-1/6·article-1/8;eu-gmp-annex-2210.5;nist-ai-600-112·3·7·9;nist-ai-rmf1.2.1·1.2.3·1.2.4·3·3.1·3.3·3.4·3.5·3.6·3.7·4·5·5.1·5.2·5.3·5.4·6 - allow-list 1 clause:
fda-device-cybersecurity-20266 - analytical performance 2 clauses:
eu-ivdrannex-i/chapter-ii·chapter-i/section-1/article-2 - Application 12 clauses:
eu-gmp-annex-11-draft17.5;eu-ivdrannex-vii/4.3;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-vi/part-c/6.5.4·annex-vii/4.3·annex-xi/part-a·annex-xi/part-b;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;nist-ai-rmf6;nistir-81837 - assurance level 2 clauses:
eu-cybersecurity-acttitle-i/article-2;eu-gmp-annex-1annex-1/11 - Audits 1 clause:
eu-gmp-chapter-5part-1 - authorised representative 39 clauses:
eu-ai-actannex-vii/3.1·annex-vii/3.2·annex-vii/4.6·annex-viii/13·chapter-i/article-3·chapter-iii/section-2/article-13/3·chapter-iii/section-3/article-20/1·chapter-iii/section-3/article-22/3·chapter-iii/section-3/article-23/1·chapter-iii/section-3/article-23/2·chapter-iii/section-5/article-48/4·chapter-iii/section-5/article-49/1·chapter-iii/section-5/article-49/2;eu-cyber-resilience-actannex-viii/part-iv/3.1·annex-viii/part-iv/3.3·chapter-i/article-3;eu-ivdrannex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-vii/4.3·chapter-i/section-1/article-2·chapter-iii/article-27/1·chapter-iii/article-27/3·chapter-iii/article-28/2·chapter-vii/section-2/article-85;eu-machinery-regulationannex-iii/part-b/5·annex-ix/3.1·annex-ix/3.3·annex-x/2·chapter-i/article-3;eu-mdrannex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-vii/4.3·annex-xi/part-a·annex-xi/part-b·chapter-i/article-2·chapter-iii/article-30/1·chapter-iii/article-30/3·chapter-iii/article-31/2·chapter-vii/section-2/article-90 - Autonomous mobile machinery 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - benefit-risk determination 8 clauses:
eu-ivdrannex-ix/chapter-ii·chapter-i/section-1/article-2·chapter-vii/section-1/article-78/3·chapter-vii/section-2/article-85;eu-mdrannex-ix/chapter-ii·chapter-i/article-2·chapter-vii/section-1/article-83/3·chapter-vii/section-2/article-90 - biometric categorisation system 2 clauses:
eu-ai-actchapter-i/article-3·chapter-iv/article-50/3 - biometric data 3 clauses:
eu-ai-actchapter-i/article-3·chapter-ii/article-5/1·chapter-iii/section-3/article-26/10 - biometric identification 6 clauses:
eu-ai-actchapter-i/article-3·chapter-ii/article-5/1·chapter-ii/article-5/2·chapter-ii/article-5/3·chapter-ii/article-5/4·chapter-iii/section-3/article-26/10 - biometric verification 1 clause:
eu-ai-actchapter-i/article-3 - Body orifice 1 clause:
eu-mdrannex-viii/chapter-i/2 - calibrator 1 clause:
eu-ivdrchapter-i/section-1/article-2 - Carrier 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - CE marking 19 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-16·chapter-iii/section-3/article-23/1·chapter-iii/section-3/article-24/1·chapter-iii/section-5/article-48/2·chapter-iii/section-5/article-48/3·chapter-iii/section-5/article-48/4·chapter-iii/section-5/article-48/5;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2·chapter-vi/article-70/1·chapter-x/article-113/3;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2·chapter-ii/article-22/1·chapter-ii/article-22/4·chapter-ii/article-22/5·chapter-vi/article-74/1·chapter-x/article-123/3 - CE marking of conformity 4 clauses:
eu-ivdrchapter-i/section-1/article-2·chapter-x/article-113/3;eu-mdrchapter-i/article-2·chapter-x/article-123/3 - Central circulatory system 1 clause:
eu-mdrannex-viii/chapter-i/2 - Central nervous system 1 clause:
eu-mdrannex-viii/chapter-i/2 - chains 8 clauses:
eu-gmp-annex-236;eu-machinery-regulationannex-iii/part-b/5·annex-iii/part-b/6.1.1·chapter-i/article-3;ich-q124;ich-q9r125·8;nist-ai-600-112 - clinical benefit 3 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrannex-i/chapter-ii·chapter-i/article-2 - clinical data 6 clauses:
eu-ivdrannex-vii/4.10·chapter-i/section-1/article-2;eu-mdrannex-ix/chapter-ii·annex-vii/4.10·chapter-i/article-2·chapter-vi/article-75/1 - clinical evaluation 13 clauses:
eu-ivdrannex-ix/chapter-i/2.2;eu-mdrannex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-ix/chapter-ii·annex-vii/4.10·annex-vii/4.5.1·annex-vii/4.6·annex-vii/4.8·chapter-i/article-2·chapter-ii/article-10/9·chapter-ii/article-8/1·chapter-v/section-2/article-54/3·chapter-vii/section-1/article-83/3 - clinical evidence 8 clauses:
eu-ivdrannex-ix/chapter-ii·annex-xiii/part-a/1.3.3·chapter-i/section-1/article-2·chapter-ii/article-8/1·chapter-vi/article-77;eu-mdrannex-ix/chapter-ii·chapter-i/article-2·chapter-vi/article-81 - clinical investigation 21 clauses:
eu-mdrannex-vi/part-a/2.1·chapter-i/article-2·chapter-vi/article-63/2·chapter-vi/article-63/6·chapter-vi/article-69/2·chapter-vi/article-70/1·chapter-vi/article-70/3·chapter-vi/article-73/1·chapter-vi/article-74/1·chapter-vi/article-75/1·chapter-vi/article-76/3·chapter-vi/article-77/1·chapter-vi/article-77/5·chapter-vi/article-77/7·chapter-vi/article-78/1·chapter-vi/article-78/11·chapter-vi/article-78/8·chapter-vi/article-80/2·chapter-vi/article-80/3·chapter-vi/article-80/4;fda-ai-guidance7 - clinical investigation plan 3 clauses:
eu-mdrchapter-i/article-2·chapter-vi/article-77/5·chapter-vi/article-80/3 - clinical performance 11 clauses:
eu-ivdrannex-i/chapter-ii·chapter-i/section-1/article-2·chapter-ii/article-15/3·chapter-vi/article-73/5·chapter-vi/article-76/3·chapter-x/article-113/3;eu-mdrannex-vi/part-a/2.1·chapter-i/article-2·chapter-v/section-2/article-55/1·chapter-v/section-2/article-57/1·chapter-vii/section-1/article-83/3 - Closed system 2 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-236 - cloud computing service 1 clause:
eu-nis2chapter-i/article-6 - common specification 1 clause:
eu-ai-actchapter-i/article-3 - companion diagnostic 3 clauses:
eu-ivdrannex-ii/1.1·annex-ix/chapter-ii·chapter-i/section-1/article-2 - Component / component 20 clauses:
eu-ai-actannex-iv/1·chapter-i/article-3·chapter-iii/section-1/article-6/1;eu-cyber-resilience-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1·article-1/5;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17.5;eu-gmp-annex-1410;eu-gmp-annex-236;eu-gmp-annex-640;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrannex-i/chapter-ii;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18;nist-ai-600-112·3;nistir-81837 - conformity assessment 79 clauses:
eu-ai-actannex-vii/1·annex-vii/4.6·annex-vii/4.7·chapter-i/article-3·chapter-iii/section-1/article-6/1·chapter-iii/section-2/article-11/1·chapter-iii/section-2/article-13/3·chapter-iii/section-3/article-16·chapter-iii/section-3/article-17/1·chapter-iii/section-3/article-22/3·chapter-iii/section-3/article-23/1·chapter-iii/section-3/article-25/2·chapter-iii/section-4/article-31/4·chapter-iii/section-5/article-43/1·chapter-iii/section-5/article-43/4·chapter-iii/section-5/article-45/1·chapter-iii/section-5/article-48/4·chapter-vi/article-57/7·chapter-vi/article-58/2;eu-cyber-resilience-actchapter-i/article-3;eu-cybersecurity-acttitle-i/article-2;eu-digital-omnibus-aiarticle-1/3·article-1/5·article-1/6;eu-ivdrannex-ii/3.2·annex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-ix/chapter-ii·annex-vii/2.1·annex-vii/2.2·annex-vii/2.3·annex-vii/3.1.1·annex-vii/3.1.2·annex-vii/3.2.3·annex-vii/3.2.6·annex-vii/3.2.7·annex-vii/4.3·annex-vii/4.5.1·annex-vii/4.5.2·annex-vii/4.6·annex-xii/chapter-i/4·chapter-i/section-1/article-2·chapter-ii/article-10/8·chapter-iii/article-28/1·chapter-iv/article-39/2·chapter-v/section-2/article-49/2·chapter-vii/section-1/article-81/2·chapter-vii/section-3/article-94/4;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3·chapter-v/article-40/1;eu-mdrannex-i/chapter-ii·annex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-ix/chapter-ii·annex-vii/2.1·annex-vii/2.2·annex-vii/2.3·annex-vii/3.1.1·annex-vii/3.1.2·annex-vii/3.2.3·annex-vii/3.2.6·annex-vii/3.2.7·annex-vii/4.3·annex-vii/4.5.1·annex-vii/4.5.2·annex-vii/4.6·annex-xi/part-a·annex-xii/chapter-i/4·chapter-i/article-2·chapter-ii/article-10/9·chapter-ii/article-22/4·chapter-iii/article-31/1·chapter-iv/article-43/2·chapter-v/section-2/article-53/2·chapter-v/section-2/article-55/1·chapter-vii/section-1/article-86/2·chapter-vii/section-3/article-99/4;nist-ai-600-112 - conformity assessment body 8 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-4/article-31/4;eu-cyber-resilience-actchapter-i/article-3;eu-cybersecurity-acttitle-i/article-2;eu-digital-omnibus-aiarticle-1/5;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2 - conformity self-assessment 1 clause:
eu-cybersecurity-acttitle-i/article-2 - consumer 4 clauses:
eu-ai-actchapter-xiii/article-113;eu-cyber-resilience-actchapter-i/article-3;nist-ai-600-112;nistir-81837 - content delivery network 1 clause:
eu-nis2chapter-i/article-6 - control material 1 clause:
eu-ivdrchapter-i/section-1/article-2 - corrective action 31 clauses:
eu-ai-actchapter-iii/section-3/article-20/2·chapter-iii/section-5/article-44/3·chapter-ix/section-2/article-73/6·chapter-ix/section-3/article-79/5·chapter-ix/section-3/article-80/2·chapter-ix/section-3/article-80/6;eu-gmp-annex-1annex-1/11;eu-ivdrannex-vii/4.10·chapter-i/section-1/article-2·chapter-ii/article-16/3·chapter-vii/section-1/article-78/3·chapter-vii/section-2/article-82/1·chapter-vii/section-2/article-84/7·chapter-vii/section-2/article-84/8·chapter-vii/section-2/article-84/9·chapter-vii/section-2/article-87/7·chapter-vii/section-3/article-90/4;eu-mdrannex-vi/part-a/2.1·annex-vii/4.10·chapter-i/article-2·chapter-ii/article-16/3·chapter-vii/section-1/article-83/3·chapter-vii/section-2/article-87/1·chapter-vii/section-2/article-89/7·chapter-vii/section-2/article-89/8·chapter-vii/section-2/article-89/9·chapter-vii/section-2/article-92/7·chapter-vii/section-3/article-95/4;fda-device-cybersecurity-20266;ich-q124;ich-q9r125 - critical infrastructure 4 clauses:
eu-ai-actchapter-i/article-3·chapter-vi/article-59/1;nist-ai-600-112;nistir-81837 - CSIRT designated as coordinator 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - custom-made device 4 clauses:
eu-mdrchapter-i/article-2·chapter-iii/article-29/2·chapter-iii/article-30/3·chapter-iii/article-31/1 - cyber threat 4 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-cybersecurity-acttitle-i/article-2;eu-nis2chapter-i/article-6;fda-device-cybersecurity-20266 - cybersecurity 19 clauses:
eu-ai-actannex-iv/2·chapter-iii/section-2/article-13/3·chapter-iii/section-2/article-15/5·chapter-vi/article-58/2·chapter-xiii/article-113;eu-cyber-resilience-actannex-vii·annex-viii/part-iv/3.2·chapter-i/article-3·chapter-i/article-7/2·chapter-v/article-57/1;eu-cybersecurity-acttitle-i/article-2;eu-digital-omnibus-aiarticle-1/5;eu-nis2chapter-i/article-6·chapter-iv/article-21/2;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-600-112;nist-ai-rmf6;nistir-81837 - cybersecurity risk 9 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-v/article-57/1;eu-nis2chapter-i/article-6·chapter-iv/article-21/2;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-600-112;nist-ai-rmf6;nistir-81837 - danger zone 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - data centre service 1 clause:
eu-nis2chapter-i/article-6 - deep fake 2 clauses:
eu-ai-actchapter-i/article-3·chapter-iv/article-50/4 - deployer 26 clauses:
eu-ai-actannex-iv/1·annex-viii/13·chapter-i/article-3·chapter-iii/section-1/article-7/2·chapter-iii/section-2/article-13/1·chapter-iii/section-2/article-14/3·chapter-iii/section-2/article-14/4·chapter-iii/section-2/article-14/5·chapter-iii/section-2/article-9/5·chapter-iii/section-3/article-20/2·chapter-iii/section-3/article-25/1·chapter-iii/section-3/article-26/10·chapter-iii/section-3/article-26/4·chapter-iii/section-3/article-26/5·chapter-iii/section-3/article-27/1·chapter-iii/section-3/article-27/2·chapter-iii/section-5/article-43/4·chapter-iv/article-50/2·chapter-ix/section-2/article-73/2·chapter-ix/section-2/article-73/4·chapter-ix/section-4/article-86/1·chapter-vi/article-60/4·chapter-viii/article-71/5;eu-digital-omnibus-aiarticle-1/3·article-1/4·article-1/6 - derivative 4 clauses:
eu-mdrannex-ix/chapter-ii·annex-xi/part-a·annex-xi/part-b·chapter-i/article-2 - device deficiency 4 clauses:
eu-ivdrchapter-i/section-1/article-2·chapter-vi/article-76/2;eu-mdrchapter-i/article-2·chapter-vi/article-80/2 - device for near-patient testing 1 clause:
eu-ivdrchapter-i/section-1/article-2 - device for performance study 1 clause:
eu-ivdrchapter-i/section-1/article-2 - device for self-testing 1 clause:
eu-ivdrchapter-i/section-1/article-2 - device software function 1 clause:
fda-device-cybersecurity-20266 - diagnostic sensitivity 2 clauses:
eu-ivdrannex-i/chapter-ii·chapter-i/section-1/article-2 - diagnostic specificity 2 clauses:
eu-ivdrannex-i/chapter-ii·chapter-i/section-1/article-2 - digital service 2 clauses:
eu-cybersecurity-acttitle-i/article-2;eu-nis2chapter-i/article-6 - digital service provider 1 clause:
eu-cybersecurity-acttitle-i/article-2 - distributor 14 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-24/2·chapter-iii/section-3/article-24/4·chapter-iii/section-3/article-25/1·chapter-iii/section-3/article-26/5·chapter-iii/section-3/article-26/8;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2·chapter-ii/article-16/3·chapter-ii/article-16/4;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2·chapter-ii/article-16/3·chapter-ii/article-16/4 - DNS 1 clause:
eu-nis2chapter-i/article-6 - DNS service provider 1 clause:
eu-nis2chapter-i/article-6 - domain name system 2 clauses:
eu-nis2chapter-i/article-2/2·chapter-i/article-6 - downstream provider 1 clause:
eu-ai-actchapter-i/article-3 - Driver 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - Dynamic test 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - economic operator 13 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-v/article-57/1;eu-ivdrchapter-i/section-1/article-2·chapter-iii/article-28/4·chapter-vii/section-3/article-88/7·chapter-vii/section-3/article-90/4·chapter-vii/section-3/article-92/2;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2·chapter-iii/article-31/4·chapter-vii/section-3/article-93/7·chapter-vii/section-3/article-95/4·chapter-vii/section-3/article-97/2 - electronic communications service 1 clause:
eu-nis2chapter-i/article-6 - electronic information system 2 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-v/article-57/1 - Electronic record 1 clause:
eu-gmp-annex-11-draft17.5 - emotion recognition system 2 clauses:
eu-ai-actchapter-i/article-3·chapter-iv/article-50/3 - end-point 2 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-i/article-7/2 - end-to-end 1 clause:
fda-device-cybersecurity-20266 - entity 14 clauses:
ema-data-quality-framework10;eu-ai-actchapter-i/article-3;eu-gmp-annex-236;eu-gmp-chapter-5part-1;eu-ivdrchapter-iii/article-24/2;eu-mdrchapter-iii/article-27/2·chapter-iii/article-29/2;eu-nis2chapter-i/article-2/2·chapter-i/article-6·chapter-iv/article-21/2·chapter-v/article-26/5;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18 - entity providing domain name registration services 1 clause:
eu-nis2chapter-i/article-6 - essential health and safety requirements 8 clauses:
eu-machinery-regulationannex-iii/part-b/5·annex-iv/part-a·annex-iv/part-b·annex-ix/3.2·annex-ix/3.3·annex-x/2·chapter-i/article-3·chapter-v/article-38/3 - ethics committee 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - European cybersecurity certificate 1 clause:
eu-cybersecurity-acttitle-i/article-2 - European cybersecurity certification scheme 1 clause:
eu-cybersecurity-acttitle-i/article-2 - European standard 3 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - exploitable vulnerability 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - falsified device 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - Federal Food, Drug, and Cosmetic Act 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - field safety corrective action 13 clauses:
eu-ivdrchapter-i/section-1/article-2·chapter-vii/section-1/article-78/3·chapter-vii/section-2/article-82/1·chapter-vii/section-2/article-84/8·chapter-vii/section-2/article-84/9·chapter-vii/section-2/article-87/7;eu-mdrannex-vi/part-a/2.1·chapter-i/article-2·chapter-vii/section-1/article-83/3·chapter-vii/section-2/article-87/1·chapter-vii/section-2/article-89/8·chapter-vii/section-2/article-89/9·chapter-vii/section-2/article-92/7 - field safety notice 4 clauses:
eu-ivdrchapter-i/section-1/article-2·chapter-vii/section-2/article-84/8;eu-mdrchapter-i/article-2·chapter-vii/section-2/article-89/8 - floating-point operation 1 clause:
eu-ai-actchapter-i/article-3 - free and open-source software 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - fully refurbishing 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - general-purpose AI model 3 clauses:
eu-ai-actchapter-i/article-3·chapter-ix/section-3/article-75/1·chapter-ix/section-3/article-75/3 - general-purpose AI system 2 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-25/1 - generic device group 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - guard 3 clauses:
eu-gmp-chapter-8part-1;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - Guided load 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - hardware 19 clauses:
ema-annex11-concept-paper1;eu-ai-actannex-iv/1·chapter-iii/section-2/article-13/3;eu-cyber-resilience-actannex-vii·chapter-i/article-3;eu-gmp-annex-1117·4.3;eu-gmp-annex-11-draft17·17.5;eu-ivdrannex-i/chapter-ii·annex-ii/3.1;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-i/chapter-ii;fda-device-cybersecurity-20266;ich-q9r125;nist-ai-600-112;nist-ai-rmf1.2.1·1.2.4;nistir-81837 - Harm 2 clauses:
fda-device-cybersecurity-20266;nist-ai-600-112 - harmonised standard 11 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-5/article-43/1;eu-cyber-resilience-actannex-viii/part-iv/3.3·chapter-i/article-3;eu-ivdrannex-ix/chapter-i/2.3·chapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·annex-ix/3.3·chapter-i/article-3;eu-mdrannex-ix/chapter-i/2.3·chapter-i/article-2 - Hazard / hazard 8 clauses:
eu-ai-actchapter-iii/section-2/article-9/5;eu-gmp-annex-1annex-1/11;eu-gmp-chapter-2part-1;eu-gmp-chapter-3part-1;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;ich-q9r125·8 - Hazard Identification 1 clause:
ich-q9r18 - health institution 3 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2·chapter-ii/article-17/3 - high-impact capabilities 1 clause:
eu-ai-actchapter-i/article-3 - ICT process 2 clauses:
eu-cybersecurity-acttitle-i/article-2;eu-nis2chapter-i/article-6 - ICT product 2 clauses:
eu-cybersecurity-acttitle-i/article-2;eu-nis2chapter-i/article-6 - ICT service 2 clauses:
eu-cybersecurity-acttitle-i/article-2;eu-nis2chapter-i/article-6 - identity management 1 clause:
fda-device-cybersecurity-20266 - implantable device 1 clause:
eu-mdrchapter-i/article-2 - importer 21 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-23/2·chapter-iii/section-3/article-24/1·chapter-iii/section-3/article-24/2·chapter-iii/section-3/article-24/4·chapter-iii/section-3/article-25/1·chapter-iii/section-3/article-26/5;eu-cyber-resilience-actchapter-i/article-3;eu-gmp-annex-137;eu-gmp-chapter-5part-1;eu-ivdrchapter-i/section-1/article-2·chapter-ii/article-16/3·chapter-ii/article-16/4·chapter-iii/article-27/1·chapter-iii/article-28/2;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2·chapter-ii/article-16/3·chapter-ii/article-16/4·chapter-iii/article-30/1·chapter-iii/article-31/2 - in vitro diagnostic medical device 1 clause:
eu-ivdrchapter-i/section-1/article-2 - incident 29 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-17/1·chapter-iii/section-3/article-26/5·chapter-ix/section-2/article-73/2·chapter-ix/section-2/article-73/4·chapter-ix/section-2/article-73/6·chapter-vi/article-60/7;eu-cyber-resilience-actchapter-i/article-3;eu-cybersecurity-acttitle-i/article-2;eu-gmp-annex-1annex-1/11;eu-gmp-annex-1113;eu-gmp-annex-11-draft17;eu-gmp-annex-236;eu-ivdrchapter-i/section-1/article-2·chapter-vii/section-2/article-82/1·chapter-vii/section-2/article-84/7·chapter-vii/section-2/article-84/9·chapter-vii/section-2/article-87/5;eu-mdrchapter-i/article-2·chapter-vii/section-2/article-87/1·chapter-vii/section-2/article-89/7·chapter-vii/section-2/article-89/9·chapter-vii/section-2/article-92/5;eu-nis2chapter-i/article-6·chapter-iv/article-21/2;fda-device-cybersecurity-20266;nist-ai-600-112;nist-ai-rmf5.2;nistir-81837 - incident handling 4 clauses:
eu-cybersecurity-acttitle-i/article-2;eu-nis2chapter-i/article-6·chapter-iv/article-21/2;nistir-81837 - indirect connection 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - informed consent 9 clauses:
eu-ai-actchapter-i/article-3·chapter-vi/article-60/4·chapter-vi/article-61/1;eu-ivdrchapter-i/section-1/article-2·chapter-vi/article-59/2;eu-mdrchapter-i/article-2·chapter-vi/article-63/2;fda-device-cybersecurity-20266;nist-ai-600-112 - Injured skin or mucous membrane 1 clause:
eu-mdrannex-viii/chapter-i/2 - input data 11 clauses:
eu-ai-actannex-iv/3·chapter-i/article-3·chapter-iii/section-2/article-12/3·chapter-iii/section-2/article-13/3·chapter-iii/section-3/article-26/4·chapter-iv/article-50/2;eu-gmp-annex-2210.5;ich-q1413.2;ich-q2r2annex-2/4;nist-ai-600-112·3 - instructions for use 30 clauses:
eu-ai-actannex-iv/1·chapter-i/article-3·chapter-iii/section-2/article-13/3·chapter-iii/section-3/article-23/1·chapter-iii/section-3/article-23/5·chapter-iii/section-3/article-24/1·chapter-iii/section-3/article-26/5·chapter-iii/section-3/article-27/1·chapter-vi/article-60/4;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrannex-i/chapter-ii·annex-ix/chapter-ii·annex-vii/4.10·annex-xii/chapter-i/4·chapter-i/section-1/article-2·chapter-ii/article-16/4·chapter-v/section-2/article-50/1·chapter-vii/section-1/article-78/3;eu-machinery-regulationannex-iii/part-b/5·annex-iv/part-a·chapter-i/article-3;eu-mdrannex-i/chapter-ii·annex-ix/chapter-ii·annex-vii/4.10·annex-xii/chapter-i/4·chapter-i/article-2·chapter-ii/article-16/4·chapter-v/section-2/article-55/1·chapter-vii/section-1/article-83/3·chapter-x/article-123/3 - intended purpose 53 clauses:
eu-ai-actannex-iv/1·annex-iv/3·annex-ix/3·annex-vii/4.7·annex-viii/13·annex-viii/5·chapter-i/article-3·chapter-iii/section-1/article-7/2·chapter-iii/section-2/article-10/2·chapter-iii/section-2/article-10/3·chapter-iii/section-2/article-10/4·chapter-iii/section-2/article-12/2·chapter-iii/section-2/article-13/3·chapter-iii/section-2/article-14/2·chapter-iii/section-2/article-8/1·chapter-iii/section-2/article-9/2·chapter-iii/section-2/article-9/8·chapter-iii/section-2/article-9/9·chapter-iii/section-3/article-19/1·chapter-iii/section-3/article-25/1·chapter-iii/section-3/article-26/4·chapter-iii/section-3/article-26/6·chapter-iii/section-3/article-27/1;eu-cyber-resilience-actannex-vii·chapter-i/article-3;eu-digital-omnibus-aiarticle-1·article-1/3;eu-gmp-annex-1410;eu-gmp-annex-1512;eu-gmp-chapter-3part-1;eu-ivdrannex-i/chapter-ii·annex-ii/1.1·annex-ix/chapter-i/2.3·annex-ix/chapter-ii·annex-xii/chapter-i/4·chapter-i/section-1/article-2·chapter-vi/article-70/1;eu-machinery-regulationchapter-i/article-3;eu-mdrannex-i/chapter-ii·annex-ii/1.1·annex-ix/chapter-i/2.3·annex-ix/chapter-ii·annex-vi/part-a/2.1·annex-viii/chapter-iii·annex-xii/chapter-i/4·chapter-i/article-2·chapter-ii/article-22/1·chapter-ii/article-22/4·chapter-vi/article-74/1;ich-q1413.2;ich-q2r2annex-2/2·annex-2/4;nist-ai-600-112 - intended use 27 clauses:
ema-data-quality-framework10;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-236;eu-gmp-annex-2210;eu-gmp-chapter-1chapter-1;eu-gmp-chapter-6part-1;eu-ivdrannex-i/chapter-i/3·annex-i/chapter-ii·annex-ix/chapter-ii·annex-vii/4.5.2;eu-machinery-regulationannex-iii/part-b/5·annex-iv/part-a·chapter-i/article-6/5;eu-mdrannex-i/chapter-i/3·annex-i/chapter-ii·annex-vii/4.5.2·annex-vii/4.9·annex-xi/part-a;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r125·8;nist-ai-600-112;nist-ai-rmf3.1·3.4·5.2 - interchangeable equipment 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - international standard 2 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-gmp-annex-1annex-1/11 - internet exchange point 1 clause:
eu-nis2chapter-i/article-6 - interventional clinical performance study 1 clause:
eu-ivdrchapter-i/section-1/article-2 - invasive device 2 clauses:
eu-mdrannex-viii/chapter-i/2·chapter-i/article-2 - investigational device 2 clauses:
eu-mdrchapter-i/article-2·chapter-vi/article-80/2 - investigator 4 clauses:
eu-ivdrchapter-i/section-1/article-2·chapter-vi/article-65/2;eu-mdrchapter-i/article-2·chapter-vi/article-69/2 - kit 1 clause:
eu-ivdrchapter-i/section-1/article-2 - label 15 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-132.1;eu-gmp-chapter-5part-1;eu-gmp-chapter-6part-1;eu-ivdrannex-i/chapter-ii·annex-ix/chapter-ii·chapter-i/section-1/article-2·chapter-ii/article-16/4·chapter-iii/article-24/1;eu-mdrannex-i/chapter-ii·chapter-i/article-2·chapter-ii/article-16/4·chapter-iii/article-27/1;ich-q9r125;nist-ai-600-112 - large-scale cybersecurity incident 1 clause:
eu-nis2chapter-i/article-6 - law enforcement 14 clauses:
eu-ai-actannex-x/4·chapter-i/article-3·chapter-ii/article-5/1·chapter-ii/article-5/2·chapter-ii/article-5/3·chapter-ii/article-5/4·chapter-iii/section-2/article-14/5·chapter-iii/section-3/article-26/10·chapter-iii/section-3/article-26/11·chapter-iii/section-3/article-26/5·chapter-iii/section-5/article-43/1·chapter-vi/article-59/1·chapter-vi/article-60/4;eu-digital-omnibus-aiarticle-1/6 - law enforcement authority 2 clauses:
eu-ai-actchapter-i/article-3·chapter-ii/article-5/2 - lay person 3 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrannex-i/chapter-ii·chapter-i/article-2 - lifetime 12 clauses:
eu-ai-actchapter-iii/section-2/article-12/1·chapter-iii/section-2/article-13/3·chapter-ix/section-1/article-72/2;eu-ivdrannex-i/chapter-ii·chapter-i/section-1/article-2·chapter-vii/section-1/article-78/2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrannex-vi/part-c/6.4.4·chapter-i/article-2·chapter-vii/section-1/article-83/2;nist-ai-rmf3.1 - lifting accessory 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - Lifting operation 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - likelihood ratio 2 clauses:
eu-ivdrannex-i/chapter-ii·chapter-i/section-1/article-2 - logical connection 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - machinery 16 clauses:
eu-ai-actchapter-xiii/article-113;eu-ivdrchapter-x/article-113/3;eu-machinery-regulationannex-iii/part-b/5·annex-iii/part-b/5.5·annex-iii/part-b/6.1.1·annex-iv/part-a·annex-iv/part-b·annex-ix/2·annex-ix/3.1·annex-ix/3.2·annex-ix/3.3·annex-ix/6·annex-x/2·chapter-i/article-3·chapter-i/article-6/5;eu-mdrchapter-x/article-123/3 - Machinery or related products for plant protection products application 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - Machinery or related products presenting risks due to their mobility 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - making available on the market 6 clauses:
eu-ai-actchapter-i/article-3·chapter-xiii/article-113;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2 - managed security service provider 1 clause:
eu-nis2chapter-i/article-6 - managed service provider 1 clause:
eu-nis2chapter-i/article-6 - manufacturer 150 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-25/3;eu-cyber-resilience-actannex-vii·annex-viii/part-iv/2·annex-viii/part-iv/3.1·annex-viii/part-iv/3.2·annex-viii/part-iv/3.3·annex-viii/part-iv/3.4·annex-viii/part-iv/3.5·annex-viii/part-iv/4.1·annex-viii/part-iv/4.2·annex-viii/part-iv/4.3·annex-viii/part-iv/6·chapter-i/article-3·chapter-v/article-57/1;eu-cybersecurity-acttitle-i/article-2;eu-digital-omnibus-aiarticle-1/5;eu-gmp-annex-1annex-1/11;eu-gmp-annex-104;eu-gmp-annex-113.1;eu-gmp-annex-132·7·8;eu-gmp-annex-1410;eu-gmp-annex-1512;eu-gmp-annex-175;eu-gmp-annex-236;eu-gmp-annex-83·5;eu-gmp-chapter-1chapter-1;eu-gmp-chapter-2part-1;eu-gmp-chapter-5part-1;eu-gmp-chapter-6part-1;eu-gmp-chapter-8part-1;eu-ivdrannex-i/chapter-ii·annex-ii/1.1·annex-ix/chapter-i/1·annex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-ix/chapter-i/2.3·annex-ix/chapter-i/2.4·annex-ix/chapter-i/3.1·annex-ix/chapter-i/3.2·annex-ix/chapter-i/3.3·annex-ix/chapter-ii·annex-vii/3.2.6·annex-vii/4.10·annex-vii/4.3·annex-vii/4.5.1·annex-vii/4.5.2·annex-vii/4.6·annex-vii/4.8·annex-vii/4.9·annex-xi/1·annex-xi/3.1·annex-xi/3.2·annex-xi/3.3·annex-xii/chapter-i/3·annex-xii/chapter-i/4·annex-xiii/part-a/1.3.3·chapter-i/section-1/article-2·chapter-ii/article-10/8·chapter-ii/article-16/3·chapter-ii/article-16/4·chapter-iii/article-24/1·chapter-iii/article-27/1·chapter-iii/article-27/3·chapter-iii/article-28/2·chapter-iv/article-40/5·chapter-iv/article-42/6·chapter-v/section-2/article-49/2·chapter-vii/section-1/article-78·chapter-vii/section-1/article-78/1·chapter-vii/section-1/article-78/3·chapter-vii/section-2/article-83/1·chapter-vii/section-2/article-84/5·chapter-vii/section-2/article-84/7·chapter-vii/section-2/article-84/8·chapter-vii/section-2/article-84/9·chapter-vii/section-2/article-85·chapter-vii/section-2/article-87/7·chapter-vii/section-2/article-87/8;eu-machinery-regulationannex-iii/part-b/5·annex-iv/part-a·annex-iv/part-b·annex-ix/2·annex-ix/3.1·annex-ix/3.2·annex-ix/3.3·annex-ix/3.4·annex-ix/3.5·annex-ix/4.1·annex-ix/4.2·annex-ix/4.3·annex-ix/4.4·annex-ix/6·annex-x/2·chapter-i/article-3·chapter-v/article-38/3;eu-mdrannex-i/chapter-ii·annex-ii/1.1·annex-ix/chapter-i/1·annex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-ix/chapter-i/2.3·annex-ix/chapter-i/2.4·annex-ix/chapter-i/3.1·annex-ix/chapter-i/3.2·annex-ix/chapter-i/3.3·annex-ix/chapter-ii·annex-vii/3.2.6·annex-vii/4.10·annex-vii/4.3·annex-vii/4.5.1·annex-vii/4.5.2·annex-vii/4.6·annex-vii/4.8·annex-vii/4.9·annex-viii/chapter-i/2·annex-xi/part-a·annex-xi/part-b·annex-xii/chapter-i/3·annex-xii/chapter-i/4·chapter-i/article-2·chapter-ii/article-10/9·chapter-ii/article-16/3·chapter-ii/article-16/4·chapter-ii/article-22/4·chapter-iii/article-27/1·chapter-iii/article-30/1·chapter-iii/article-30/3·chapter-iii/article-31/2·chapter-iv/article-44/5·chapter-iv/article-46/7·chapter-v/section-2/article-53/2·chapter-vii/section-1/article-83·chapter-vii/section-1/article-83/1·chapter-vii/section-1/article-83/3·chapter-vii/section-2/article-88/1·chapter-vii/section-2/article-89/5·chapter-vii/section-2/article-89/7·chapter-vii/section-2/article-89/8·chapter-vii/section-2/article-89/9·chapter-vii/section-2/article-90·chapter-vii/section-2/article-92/7·chapter-vii/section-2/article-92/8;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;nistir-81837 - market surveillance 93 clauses:
eu-ai-actchapter-i/article-3·chapter-ii/article-5/4·chapter-iii/section-3/article-20/2·chapter-iii/section-3/article-22/3·chapter-iii/section-3/article-23/2·chapter-iii/section-3/article-26/10·chapter-iii/section-3/article-26/5·chapter-iii/section-5/article-43/1·chapter-iii/section-5/article-45/1·chapter-iii/section-5/article-46/3·chapter-iii/section-5/article-46/5·chapter-ix/section-3/article-74/6·chapter-ix/section-3/article-75/1·chapter-ix/section-3/article-75/3·chapter-ix/section-3/article-76/5·chapter-ix/section-3/article-77/3·chapter-ix/section-3/article-79/2·chapter-ix/section-3/article-79/5·chapter-ix/section-3/article-79/6·chapter-ix/section-3/article-79/7·chapter-ix/section-3/article-79/9·chapter-ix/section-3/article-80/1·chapter-ix/section-3/article-80/2·chapter-ix/section-3/article-80/3·chapter-ix/section-3/article-80/7·chapter-ix/section-3/article-82/1·chapter-ix/section-3/article-83/2·chapter-vi/article-57/7·chapter-vi/article-60/4·chapter-vi/article-60/7·chapter-xii/article-99/7·chapter-xiii/article-113;eu-cyber-resilience-actannex-vii·chapter-i/article-3·chapter-v/article-57/1·chapter-vii/article-64/6;eu-digital-omnibus-aiarticle-1/6;eu-ivdrannex-i/chapter-i/3·annex-ix/chapter-i/2.1·annex-ix/chapter-i/3.2·annex-ix/chapter-i/3.3·annex-ix/chapter-ii·annex-vii/4.10·annex-vii/4.5.2·annex-vii/4.8·annex-xiii/part-a/1.3.3·chapter-i/section-1/article-2·chapter-ii/article-10/8·chapter-ii/article-10/9·chapter-ii/article-15/3·chapter-ii/article-8/1·chapter-iii/article-30/2·chapter-iv/article-42/6·chapter-vii/section-1/article-78·chapter-vii/section-1/article-78/1·chapter-vii/section-1/article-78/2·chapter-vii/section-1/article-78/3·chapter-vii/section-1/article-79·chapter-vii/section-2/article-83/1·chapter-vii/section-2/article-87·chapter-vii/section-3/article-88/8·chapter-vii/section-3/article-95·chapter-vii/section-3/article-95/1·chapter-x/article-113/3;eu-machinery-regulationchapter-i/article-3·chapter-i/article-6/5·chapter-v/article-40/1;eu-mdrannex-i/chapter-i/3·annex-ix/chapter-i/2.1·annex-ix/chapter-i/3.2·annex-ix/chapter-i/3.3·annex-ix/chapter-ii·annex-vii/4.10·annex-vii/4.5.2·annex-vii/4.8·annex-xi/part-b·chapter-i/article-2·chapter-ii/article-10/10·chapter-ii/article-10/9·chapter-ii/article-15/3·chapter-ii/article-8/1·chapter-iii/article-33/2·chapter-vii/section-1/article-83·chapter-vii/section-1/article-83/1·chapter-vii/section-1/article-83/2·chapter-vii/section-1/article-83/3·chapter-vii/section-1/article-84·chapter-vii/section-2/article-88/1·chapter-vii/section-2/article-92·chapter-vii/section-3/article-100·chapter-vii/section-3/article-100/1·chapter-vii/section-3/article-93/8·chapter-x/article-123/3 - market surveillance authority 28 clauses:
eu-ai-actchapter-i/article-3·chapter-ii/article-5/4·chapter-iii/section-3/article-26/10·chapter-iii/section-3/article-26/5·chapter-iii/section-5/article-43/1·chapter-iii/section-5/article-46/3·chapter-iii/section-5/article-46/5·chapter-ix/section-3/article-74/6·chapter-ix/section-3/article-75/1·chapter-ix/section-3/article-75/3·chapter-ix/section-3/article-76/5·chapter-ix/section-3/article-77/3·chapter-ix/section-3/article-79/2·chapter-ix/section-3/article-79/5·chapter-ix/section-3/article-79/7·chapter-ix/section-3/article-80/1·chapter-ix/section-3/article-80/2·chapter-ix/section-3/article-80/3·chapter-ix/section-3/article-80/7·chapter-ix/section-3/article-82/1·chapter-ix/section-3/article-83/2·chapter-vi/article-60/4·chapter-vi/article-60/7;eu-cyber-resilience-actannex-vii·chapter-i/article-3·chapter-v/article-57/1;eu-digital-omnibus-aiarticle-1/6;eu-machinery-regulationchapter-i/article-3 - medical device 7 clauses:
eu-gmp-annex-1410;eu-ivdrchapter-i/section-1/article-2·chapter-iii/article-24/12;eu-mdrchapter-i/article-2·chapter-iii/article-27/12;fda-ai-guidance7;fda-device-cybersecurity-20266 - Metadata 2 clauses:
ema-data-quality-framework10;nist-ai-600-112 - micro, small and medium-sized enterprise 1 clause:
eu-digital-omnibus-aiarticle-1 - nanomaterial 3 clauses:
eu-mdrannex-viii/chapter-iii·chapter-i/article-2·chapter-x/article-123/3 - national accreditation body 2 clauses:
eu-cybersecurity-acttitle-i/article-2;eu-machinery-regulationchapter-i/article-3 - national competent authority 11 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-16·chapter-iii/section-4/article-36/9·chapter-vi/article-57/12·chapter-vi/article-57/7·chapter-vi/article-58/2;eu-digital-omnibus-aiarticle-1/6;eu-gmp-annex-137;eu-gmp-annex-1410;eu-gmp-annex-236;eu-ivdrchapter-iv/article-42/6 - national cybersecurity certification scheme 1 clause:
eu-cybersecurity-acttitle-i/article-2 - national cybersecurity strategy 1 clause:
eu-nis2chapter-i/article-6 - national strategy on the security of network and information systems 1 clause:
eu-cybersecurity-acttitle-i/article-2 - near miss 2 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-nis2chapter-i/article-6 - negative predictive value 2 clauses:
eu-ivdrannex-i/chapter-ii·chapter-i/section-1/article-2 - network and information system 3 clauses:
eu-cybersecurity-acttitle-i/article-2;eu-nis2chapter-i/article-6·chapter-v/article-26/5 - non-personal data 2 clauses:
eu-ai-actchapter-i/article-3·chapter-vi/article-59/1 - non-viable 5 clauses:
eu-gmp-annex-1annex-1/11;eu-mdrannex-i/chapter-ii·annex-ix/chapter-ii·annex-viii/chapter-iii·chapter-i/article-2 - notified body 134 clauses:
eu-ai-actannex-vii/3.1·annex-vii/3.2·annex-vii/3.4·annex-vii/4.1·annex-vii/4.4·annex-vii/4.5·annex-vii/4.6·annex-vii/4.7·annex-vii/5.1·annex-vii/5.3·chapter-i/article-3·chapter-iii/section-3/article-20/2·chapter-iii/section-3/article-22/3·chapter-iii/section-3/article-23/5·chapter-iii/section-4/article-34/2·chapter-iii/section-4/article-36/8·chapter-iii/section-4/article-36/9·chapter-iii/section-5/article-43/1·chapter-iii/section-5/article-44/3·chapter-iii/section-5/article-45/2·chapter-iii/section-5/article-48/4·chapter-ix/section-2/article-73/6·chapter-ix/section-3/article-79/2;eu-cyber-resilience-actannex-viii/part-iv/3.1·annex-viii/part-iv/3.3·annex-viii/part-iv/3.5·annex-viii/part-iv/4.2·annex-viii/part-iv/4.3·annex-viii/part-iv/6·annex-viii/part-iv/7·chapter-i/article-3;eu-digital-omnibus-aiarticle-1/5·article-1/6;eu-ivdrannex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-ix/chapter-i/2.3·annex-ix/chapter-i/2.4·annex-ix/chapter-i/3.2·annex-ix/chapter-i/3.3·annex-ix/chapter-ii·annex-vi/part-a/2.1·annex-vii/2.1·annex-vii/2.2·annex-vii/2.3·annex-vii/3.1.1·annex-vii/3.1.2·annex-vii/3.2.3·annex-vii/3.2.7·annex-vii/4.10·annex-vii/4.3·annex-vii/4.5.1·annex-vii/4.5.2·annex-vii/4.6·annex-vii/4.8·annex-vii/4.9·annex-xi/3.1·annex-xi/3.3·annex-xii/chapter-i/5·annex-xii/chapter-i/7·chapter-i/section-1/article-2·chapter-ii/article-16/4·chapter-iii/article-28/1·chapter-iv/article-38/10·chapter-iv/article-40/5·chapter-iv/article-42/2·chapter-iv/article-42/6·chapter-iv/article-43/4·chapter-v/section-2/article-49/2·chapter-v/section-2/article-50/1·chapter-v/section-2/article-51/5·chapter-vii/section-1/article-81/2·chapter-vii/section-2/article-87/9·chapter-vii/section-3/article-90/2·chapter-vii/section-3/article-90/4·chapter-vii/section-3/article-94/4·chapter-vii/section-3/article-95/2·chapter-x/article-113/3;eu-machinery-regulationannex-ix/3.1·annex-ix/3.3·annex-ix/3.5·annex-ix/4.2·annex-ix/4.3·annex-ix/4.4·annex-ix/6·annex-ix/7·annex-x/2·chapter-i/article-3·chapter-v/article-38/3·chapter-v/article-40/1;eu-mdrannex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-ix/chapter-i/2.3·annex-ix/chapter-i/2.4·annex-ix/chapter-i/3.2·annex-ix/chapter-i/3.3·annex-ix/chapter-ii·annex-vi/part-a/2.1·annex-vii/2.1·annex-vii/2.2·annex-vii/2.3·annex-vii/3.1.1·annex-vii/3.1.2·annex-vii/3.2.3·annex-vii/3.2.7·annex-vii/4.10·annex-vii/4.3·annex-vii/4.5.1·annex-vii/4.5.2·annex-vii/4.6·annex-vii/4.8·annex-vii/4.9·annex-xi/part-a·annex-xi/part-b·annex-xii/chapter-i/5·annex-xii/chapter-i/7·chapter-i/article-2·chapter-ii/article-16/4·chapter-iii/article-31/1·chapter-iv/article-42/10·chapter-iv/article-44/5·chapter-iv/article-46/2·chapter-iv/article-46/7·chapter-iv/article-47/4·chapter-v/section-2/article-53/2·chapter-v/section-2/article-54/3·chapter-v/section-2/article-55/1·chapter-v/section-2/article-56/5·chapter-vii/section-1/article-86/2·chapter-vii/section-2/article-92/9·chapter-vii/section-3/article-100/2·chapter-vii/section-3/article-95/2·chapter-vii/section-3/article-95/4·chapter-vii/section-3/article-99/4·chapter-x/article-123/3 - notifying authority 8 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-4/article-36/8·chapter-iii/section-5/article-45/1;eu-cyber-resilience-actchapter-i/article-3·chapter-iv/article-43/2;eu-digital-omnibus-aiarticle-1/5;eu-machinery-regulationannex-ix/7·chapter-v/article-40/1 - online marketplace 1 clause:
eu-nis2chapter-i/article-6 - online search engine 2 clauses:
eu-digital-omnibus-aiarticle-1/6;eu-nis2chapter-i/article-6 - open-source software steward 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - operator 37 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-24/4·chapter-iii/section-4/article-31/4·chapter-ix/section-3/article-79/2·chapter-ix/section-3/article-79/5·chapter-ix/section-3/article-79/6·chapter-ix/section-3/article-82/1·chapter-xii/article-99/7;eu-cyber-resilience-actchapter-i/article-3·chapter-v/article-57/1;eu-cybersecurity-acttitle-i/article-2;eu-digital-omnibus-aiarticle-1/6·article-1/8;eu-gmp-annex-1annex-1/11;eu-gmp-annex-116;eu-gmp-annex-236;eu-gmp-annex-2210·10.5;eu-gmp-chapter-2part-1;eu-ivdrchapter-i/section-1/article-2·chapter-iii/article-28/4·chapter-vii/section-3/article-88/7·chapter-vii/section-3/article-90/4·chapter-vii/section-3/article-92/2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrchapter-i/article-2·chapter-iii/article-31/4·chapter-vii/section-3/article-93/7·chapter-vii/section-3/article-95/4·chapter-vii/section-3/article-97/2;fda-device-cybersecurity-20266;nist-ai-600-112;nist-ai-rmf3.4·5.2·6;nistir-81837 - operator of essential services 1 clause:
eu-cybersecurity-acttitle-i/article-2 - particle 6 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-1512;eu-gmp-annex-28;eu-mdrchapter-i/article-2;ich-q1413.2;ich-q9r125 - partly completed machinery 4 clauses:
eu-machinery-regulationannex-iii/part-b/5·annex-iv/part-a·annex-iv/part-b·chapter-i/article-3 - performance 111 clauses:
ema-data-quality-framework10;ema-pics-annex15-concept2;eu-ai-actannex-iv/2·annex-iv/3·annex-iv/4·annex-iv/9·chapter-i/article-3·chapter-iii/section-2/article-13/3·chapter-iii/section-2/article-14/4·chapter-iii/section-2/article-15/5·chapter-iii/section-4/article-31/8·chapter-iii/section-5/article-40/2·chapter-iii/section-5/article-43/4·chapter-ix/section-1/article-72/2;eu-digital-omnibus-aiarticle-1/3·article-1/6;eu-gmp-annex-1annex-1/11;eu-gmp-annex-114.6;eu-gmp-annex-11-draft17·17.5;eu-gmp-annex-1512;eu-gmp-annex-175;eu-gmp-annex-236;eu-gmp-annex-2210·10.3·10.5;eu-gmp-chapter-1chapter-1;eu-gmp-chapter-2part-1;eu-gmp-chapter-5part-1;eu-gmp-chapter-6part-1;eu-ivdrannex-i/chapter-ii·annex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-ix/chapter-ii·annex-vi/part-a/2.1·annex-vii/3.1.1·annex-vii/4.10·annex-vii/4.5.1·annex-vii/4.5.2·annex-vii/4.6·annex-vii/4.8·annex-xiii/part-a/1.3.3·chapter-i/section-1/article-2·chapter-ii/article-10/8·chapter-ii/article-15/3·chapter-ii/article-8/1·chapter-iii/article-24/1·chapter-iii/article-30/2·chapter-v/section-2/article-50/1·chapter-v/section-2/article-52·chapter-vi/article-59/2·chapter-vi/article-59/6·chapter-vi/article-65/2·chapter-vi/article-66/1·chapter-vi/article-66/3·chapter-vi/article-69·chapter-vi/article-69/1·chapter-vi/article-69/2·chapter-vi/article-70/1·chapter-vi/article-71/1·chapter-vi/article-72/3·chapter-vi/article-73/1·chapter-vi/article-73/5·chapter-vi/article-73/7·chapter-vi/article-74/1·chapter-vi/article-74/11·chapter-vi/article-74/8·chapter-vi/article-76/2·chapter-vi/article-76/3·chapter-vi/article-76/4·chapter-vi/article-77·chapter-vii/section-1/article-78/2·chapter-vii/section-1/article-78/3·chapter-vii/section-2/article-82/1·chapter-vii/section-2/article-83/1·chapter-x/article-113/3;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-i/chapter-ii·annex-ii/1.1·annex-ix/chapter-i/2.2·annex-ix/chapter-ii·annex-vi/part-a/2.1·annex-vii/3.1.1·annex-vii/4.10·annex-vii/4.5.2·annex-viii/chapter-iii·chapter-i/article-2·chapter-ii/article-10/9·chapter-ii/article-17/3·chapter-v/section-2/article-55/1·chapter-v/section-2/article-57/1·chapter-vi/article-81·chapter-vii/section-1/article-83/2·chapter-vii/section-1/article-83/3·chapter-x/article-123/3;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;ich-q1413.2;ich-q2r2annex-2/2·annex-2/4;ich-q9r125·8;nist-ai-600-112·6;nist-ai-rmf1.1·3.1·5.2·5.3·6;nistir-81837 - performance evaluation 12 clauses:
eu-ivdrannex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-ix/chapter-ii·annex-vii/4.10·annex-vii/4.5.1·annex-vii/4.5.2·annex-vii/4.6·annex-vii/4.8·annex-xiii/part-a/1.3.3·chapter-i/section-1/article-2·chapter-ii/article-10/8·chapter-vii/section-1/article-78/3 - performance of a device 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - performance of an AI system 1 clause:
eu-ai-actchapter-i/article-3 - performance study 22 clauses:
eu-ivdrannex-vi/part-a/2.1·chapter-i/section-1/article-2·chapter-ii/article-10/8·chapter-vi/article-59/2·chapter-vi/article-59/6·chapter-vi/article-65/2·chapter-vi/article-66/1·chapter-vi/article-66/3·chapter-vi/article-69/1·chapter-vi/article-70/1·chapter-vi/article-71/1·chapter-vi/article-72/3·chapter-vi/article-73/1·chapter-vi/article-73/5·chapter-vi/article-73/7·chapter-vi/article-74/1·chapter-vi/article-74/11·chapter-vi/article-74/8·chapter-vi/article-76/2·chapter-vi/article-76/3·chapter-vi/article-76/4·chapter-vii/section-2/article-82/1 - performance study plan 3 clauses:
eu-ivdrchapter-i/section-1/article-2·chapter-vi/article-73/5·chapter-vi/article-76/3 - personal data 20 clauses:
eu-ai-actannex-v/5·chapter-i/article-3·chapter-iii/section-1/article-7/2·chapter-iii/section-2/article-10/2·chapter-iii/section-3/article-19/1·chapter-iii/section-3/article-26/10·chapter-iii/section-3/article-26/6·chapter-iv/article-50/3·chapter-vi/article-59/1·chapter-vi/article-60/4·chapter-viii/article-71/5·chapter-xiii/article-113;eu-cyber-resilience-actchapter-i/article-3·chapter-i/article-7/2;eu-digital-omnibus-aiarticle-1·article-1/3·article-1/6;eu-ivdrchapter-x/article-113/3;eu-mdrchapter-x/article-123/3;nist-ai-600-112 - physical connection 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - placing on the market 17 clauses:
eu-ai-actchapter-i/article-2/1·chapter-i/article-3·chapter-ii/article-5/1·chapter-iii/section-1/article-6/1·chapter-iii/section-3/article-17/1·chapter-iii/section-5/article-49/1·chapter-iii/section-5/article-49/2·chapter-ix/section-3/article-74/6·chapter-vi/article-60/2;eu-cyber-resilience-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/3·article-1/6;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrchapter-i/article-2·chapter-iii/article-29/2 - positive predictive value 2 clauses:
eu-ivdrannex-i/chapter-ii·chapter-i/section-1/article-2 - post-market monitoring system 8 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-2/article-9/2·chapter-iii/section-3/article-17/1·chapter-ix/section-1/article-72/1·chapter-ix/section-1/article-72/2·chapter-ix/section-1/article-72/3·chapter-ix/section-1/article-72/4;eu-digital-omnibus-aiarticle-1/6 - post-market surveillance 44 clauses:
eu-ivdrannex-i/chapter-i/3·annex-ix/chapter-i/2.1·annex-ix/chapter-i/3.2·annex-ix/chapter-i/3.3·annex-ix/chapter-ii·annex-vii/4.10·annex-vii/4.5.2·annex-vii/4.8·annex-xiii/part-a/1.3.3·chapter-i/section-1/article-2·chapter-ii/article-10/8·chapter-ii/article-10/9·chapter-ii/article-15/3·chapter-ii/article-8/1·chapter-iii/article-30/2·chapter-vii/section-1/article-78/1·chapter-vii/section-1/article-78/2·chapter-vii/section-1/article-78/3·chapter-vii/section-1/article-79·chapter-vii/section-2/article-83/1·chapter-vii/section-2/article-87·chapter-x/article-113/3;eu-mdrannex-i/chapter-i/3·annex-ix/chapter-i/2.1·annex-ix/chapter-i/3.2·annex-ix/chapter-i/3.3·annex-ix/chapter-ii·annex-vii/4.10·annex-vii/4.5.2·annex-vii/4.8·annex-xi/part-b·chapter-i/article-2·chapter-ii/article-10/10·chapter-ii/article-10/9·chapter-ii/article-15/3·chapter-ii/article-8/1·chapter-iii/article-33/2·chapter-vii/section-1/article-83/1·chapter-vii/section-1/article-83/2·chapter-vii/section-1/article-83/3·chapter-vii/section-1/article-84·chapter-vii/section-2/article-88/1·chapter-vii/section-2/article-92·chapter-x/article-123/3 - post-remote biometric identification system 2 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-26/10 - predictive value 2 clauses:
eu-ivdrannex-i/chapter-ii·chapter-i/section-1/article-2 - procedure pack 9 clauses:
eu-mdrannex-vi/part-c/6.3.1·annex-vi/part-c/6.3.2·annex-vi/part-c/6.3.3·chapter-i/article-2·chapter-ii/article-22/1·chapter-ii/article-22/2·chapter-ii/article-22/4·chapter-ii/article-22/5·chapter-iii/article-29/2 - Product Lifecycle 4 clauses:
fda-ai-guidance7;ich-q124;ich-q1413.2;ich-q9r18 - product with digital elements 6 clauses:
eu-cyber-resilience-actannex-vii·annex-viii/part-iv/3.3·annex-viii/part-iv/6·chapter-i/article-3·chapter-i/article-7/2·chapter-v/article-57/1 - professional user 2 clauses:
eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2 - profiling 3 clauses:
eu-ai-actchapter-i/article-3·chapter-ii/article-5/1·chapter-iii/section-1/article-6/3 - protective device 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - provider 85 clauses:
ema-annex11-concept-paper1·8;ema-data-quality-framework10;eu-ai-actannex-iv/1·annex-iv/2·annex-iv/6·annex-vi/2·annex-vi/3·annex-vi/4·annex-vii/3.1·annex-vii/3.2·annex-vii/3.3·annex-vii/3.4·annex-vii/4.1·annex-vii/4.4·annex-vii/4.6·annex-vii/4.7·annex-vii/5.1·annex-vii/5.3·annex-viii/13·chapter-i/article-3·chapter-iii/section-1/article-6/4·chapter-iii/section-2/article-13/1·chapter-iii/section-2/article-13/3·chapter-iii/section-2/article-14/3·chapter-iii/section-3/article-18/1·chapter-iii/section-3/article-20/2·chapter-iii/section-3/article-22/3·chapter-iii/section-3/article-23/1·chapter-iii/section-3/article-23/2·chapter-iii/section-3/article-24/1·chapter-iii/section-3/article-24/2·chapter-iii/section-3/article-24/4·chapter-iii/section-3/article-25/1·chapter-iii/section-3/article-25/2·chapter-iii/section-3/article-25/3·chapter-iii/section-3/article-25/4·chapter-iii/section-3/article-26/5·chapter-iii/section-3/article-26/8·chapter-iii/section-3/article-27/1·chapter-iii/section-3/article-27/2·chapter-iii/section-4/article-31/4·chapter-iii/section-4/article-31/8·chapter-iii/section-4/article-34/2·chapter-iii/section-4/article-36/8·chapter-iii/section-4/article-36/9·chapter-iii/section-5/article-43/1·chapter-iii/section-5/article-43/4·chapter-iii/section-5/article-44/3·chapter-iii/section-5/article-47/1·chapter-iii/section-5/article-48/4·chapter-iii/section-5/article-49/1·chapter-iii/section-5/article-49/2·chapter-ix/section-1/article-72/2·chapter-ix/section-2/article-73/2·chapter-ix/section-2/article-73/4·chapter-ix/section-2/article-73/6·chapter-ix/section-3/article-74/13·chapter-ix/section-3/article-75/1·chapter-ix/section-3/article-80/1·chapter-ix/section-3/article-80/2·chapter-ix/section-3/article-80/3·chapter-ix/section-3/article-80/4·chapter-ix/section-3/article-80/6·chapter-ix/section-3/article-80/7·chapter-vi/article-57/7·chapter-vi/article-58/2·chapter-vi/article-59/1·chapter-vi/article-60/4·chapter-vi/article-60/7·chapter-vi/article-61/1·chapter-viii/article-71/5;eu-cybersecurity-acttitle-i/article-2;eu-digital-omnibus-aiarticle-1/3·article-1/4·article-1/5·article-1/6;eu-gmp-annex-11-draft17;eu-gmp-annex-2210;eu-nis2annex-i/1·chapter-i/article-2/2·chapter-i/article-6;fda-device-cybersecurity-20266;nist-ai-600-112;nistir-81837 - public administration entity 2 clauses:
eu-nis2chapter-i/article-2/2·chapter-i/article-6 - public electronic communications network 1 clause:
eu-nis2chapter-i/article-6 - publicly accessible space 1 clause:
eu-ai-actchapter-i/article-3 - putting into service 17 clauses:
eu-ai-actchapter-i/article-2/1·chapter-i/article-3·chapter-ii/article-5/1·chapter-iii/section-1/article-6/1·chapter-iii/section-3/article-17/1·chapter-iii/section-3/article-26/7·chapter-iii/section-5/article-49/1·chapter-iii/section-5/article-49/2·chapter-iii/section-5/article-49/3·chapter-ix/section-3/article-74/6·chapter-vi/article-60/2;eu-digital-omnibus-aiarticle-1/3·article-1/6;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrchapter-i/article-2 - qualified trust service 1 clause:
eu-nis2chapter-i/article-6 - qualified trust service provider 1 clause:
eu-nis2chapter-i/article-6 - Quality 46 clauses:
ema-annex11-concept-paper1;ema-data-quality-framework10·20;eu-ai-actannex-vii/3·chapter-iii/section-3/article-17;eu-cyber-resilience-actannex-viii/part-iv/3;eu-gmp-annex-1annex-1/11·annex-1/3;eu-gmp-annex-104;eu-gmp-annex-113.4;eu-gmp-annex-11-draft17·3;eu-gmp-annex-137;eu-gmp-annex-1410;eu-gmp-annex-1511.4·12;eu-gmp-annex-162.2;eu-gmp-annex-175;eu-gmp-annex-236;eu-gmp-annex-213·3.1·5.1.1;eu-gmp-annex-2210;eu-gmp-annex-83·5;eu-gmp-chapter-1chapter-1;eu-gmp-chapter-2part-1;eu-gmp-chapter-3part-1;eu-gmp-chapter-5part-1;eu-gmp-chapter-6part-1;eu-gmp-chapter-8part-1;eu-ivdrannex-ix/chapter-i/2·annex-vii/4.5.2·annex-xi/3;eu-machinery-regulationannex-ix/3;eu-mdrannex-ix/chapter-i/2·annex-vii/4.5.2·annex-xi/part-a;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;ich-q1413.2;ich-q2r2annex-2/1.2;ich-q9r125·8;nistir-81837 - Quality Risk Management 12 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-162.2;eu-gmp-annex-2210;eu-gmp-chapter-1chapter-1;eu-gmp-chapter-3part-1;eu-gmp-chapter-5part-1;eu-gmp-chapter-8part-1;fda-ai-guidance7;ich-q124;ich-q1413.2;ich-q9r18 - Quality System 17 clauses:
ema-annex11-concept-paper1;ema-data-quality-framework10;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17·3;eu-gmp-annex-175;eu-gmp-annex-213·3.1·5.1.1;eu-gmp-chapter-1chapter-1;eu-gmp-chapter-2part-1;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;ich-q1413.2;ich-q2r2annex-2/1.2;ich-q9r18 - real-time remote biometric identification system 1 clause:
eu-ai-actchapter-i/article-3 - real-world testing plan 3 clauses:
eu-ai-actchapter-i/article-3·chapter-vi/article-60/4;eu-digital-omnibus-aiarticle-1/6 - reasonably foreseeable misuse 11 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-2/article-13/3·chapter-iii/section-2/article-14/2·chapter-iii/section-2/article-9/2;eu-cyber-resilience-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/3;eu-ivdrannex-i/chapter-i/3;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-6/5;eu-mdrannex-i/chapter-i/3;fda-device-cybersecurity-20266 - reasonably foreseeable use 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - recall 20 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-20/1·chapter-iii/section-3/article-24/4·chapter-ix/section-3/article-79/2·chapter-ix/section-3/article-79/5·chapter-vi/article-60/7;eu-cyber-resilience-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/6;eu-gmp-annex-236;eu-gmp-chapter-1chapter-1;eu-gmp-chapter-8part-1;eu-ivdrchapter-i/section-1/article-2·chapter-vii/section-3/article-90/4;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2·chapter-vii/section-3/article-95/4;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r125·8 - recall of an AI system 1 clause:
eu-ai-actchapter-i/article-3 - remote biometric identification system 5 clauses:
eu-ai-actchapter-i/article-3·chapter-ii/article-5/2·chapter-ii/article-5/3·chapter-ii/article-5/4·chapter-iii/section-3/article-26/10 - remote data processing 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - removable mechanical transmission device 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - representative 69 clauses:
ema-data-quality-framework10;eu-ai-actannex-vii/3.1·annex-vii/3.2·annex-vii/4.6·annex-viii/13·chapter-i/article-3·chapter-iii/section-2/article-10/3·chapter-iii/section-2/article-13/3·chapter-iii/section-3/article-20/1·chapter-iii/section-3/article-22/3·chapter-iii/section-3/article-23/1·chapter-iii/section-3/article-23/2·chapter-iii/section-3/article-26/4·chapter-iii/section-5/article-48/4·chapter-iii/section-5/article-49/1·chapter-iii/section-5/article-49/2·chapter-vi/article-60/4·chapter-vi/article-61/1·chapter-xiii/article-113;eu-cyber-resilience-actannex-viii/part-iv/3.1·annex-viii/part-iv/3.3·chapter-i/article-3;eu-digital-omnibus-aiarticle-1/6;eu-gmp-annex-1annex-1/11;eu-gmp-annex-161.5.5;eu-gmp-annex-175;eu-gmp-annex-236;eu-gmp-annex-2210;eu-gmp-chapter-6part-1;eu-ivdrannex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-ix/chapter-i/2.3·annex-ix/chapter-i/3.2·annex-vii/4.3·annex-vii/4.5.1·chapter-i/section-1/article-2·chapter-iii/article-27/1·chapter-iii/article-27/3·chapter-iii/article-28/2·chapter-vi/article-59/2·chapter-vii/section-2/article-85;eu-machinery-regulationannex-iii/part-b/5·annex-ix/3.1·annex-ix/3.3·annex-x/2·chapter-i/article-3;eu-mdrannex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-ix/chapter-i/2.3·annex-ix/chapter-i/3.2·annex-vii/4.3·annex-vii/4.5.1·annex-xi/part-a·annex-xi/part-b·chapter-i/article-2·chapter-iii/article-30/1·chapter-iii/article-30/3·chapter-iii/article-31/2·chapter-vi/article-63/2·chapter-vii/section-2/article-90;eu-nis2chapter-i/article-6;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;ich-q1413.2;nist-ai-600-112·6;nist-ai-rmf3.7;nistir-81837 - reprocessing 6 clauses:
eu-gmp-annex-1410;eu-gmp-chapter-5part-1;eu-gmp-chapter-6part-1;eu-mdrchapter-i/article-2·chapter-ii/article-17/3;ich-q9r125 - Requirements 13 clauses:
ema-data-quality-framework10;ema-pics-annex15-concept2;eu-gmp-annex-1annex-1/11;eu-gmp-annex-114.4;eu-gmp-annex-11-draft17·6;eu-gmp-annex-1410;eu-ivdrchapter-x/article-113/3;eu-machinery-regulationannex-iii/part-b/5;eu-mdrchapter-x/article-123/3;fda-device-cybersecurity-20266;ich-q124;nistir-81837 - research organisation 1 clause:
eu-nis2chapter-i/article-6 - Reusable surgical instrument 1 clause:
eu-mdrannex-viii/chapter-i/2 - Risk / risk 231 clauses:
ema-annex11-concept-paper1;ema-pics-annex15-concept2;eu-ai-actannex-iv/5·annex-vii/4.5·annex-viii/13·chapter-i/article-2/12·chapter-i/article-3·chapter-ii/article-5/1·chapter-iii/section-1/article-6/1·chapter-iii/section-1/article-6/3·chapter-iii/section-1/article-6/4·chapter-iii/section-1/article-7/3·chapter-iii/section-2/article-10/2·chapter-iii/section-2/article-10/3·chapter-iii/section-2/article-10/4·chapter-iii/section-2/article-11/1·chapter-iii/section-2/article-11/2·chapter-iii/section-2/article-12/1·chapter-iii/section-2/article-12/2·chapter-iii/section-2/article-12/3·chapter-iii/section-2/article-13/1·chapter-iii/section-2/article-13/3·chapter-iii/section-2/article-14/2·chapter-iii/section-2/article-14/3·chapter-iii/section-2/article-14/4·chapter-iii/section-2/article-14/5·chapter-iii/section-2/article-15/4·chapter-iii/section-2/article-15/5·chapter-iii/section-2/article-8/1·chapter-iii/section-2/article-8/2·chapter-iii/section-2/article-9·chapter-iii/section-2/article-9/1·chapter-iii/section-2/article-9/2·chapter-iii/section-2/article-9/3·chapter-iii/section-2/article-9/5·chapter-iii/section-2/article-9/8·chapter-iii/section-2/article-9/9·chapter-iii/section-3/article-16·chapter-iii/section-3/article-17/1·chapter-iii/section-3/article-18/1·chapter-iii/section-3/article-19/1·chapter-iii/section-3/article-20/1·chapter-iii/section-3/article-20/2·chapter-iii/section-3/article-21/1·chapter-iii/section-3/article-21/2·chapter-iii/section-3/article-22/3·chapter-iii/section-3/article-23/1·chapter-iii/section-3/article-23/2·chapter-iii/section-3/article-23/3·chapter-iii/section-3/article-23/4·chapter-iii/section-3/article-23/5·chapter-iii/section-3/article-23/6·chapter-iii/section-3/article-23/7·chapter-iii/section-3/article-24/1·chapter-iii/section-3/article-24/2·chapter-iii/section-3/article-24/3·chapter-iii/section-3/article-24/4·chapter-iii/section-3/article-24/5·chapter-iii/section-3/article-24/6·chapter-iii/section-3/article-25/1·chapter-iii/section-3/article-25/2·chapter-iii/section-3/article-25/3·chapter-iii/section-3/article-25/4·chapter-iii/section-3/article-26/10·chapter-iii/section-3/article-26/11·chapter-iii/section-3/article-26/12·chapter-iii/section-3/article-26/4·chapter-iii/section-3/article-26/5·chapter-iii/section-3/article-26/6·chapter-iii/section-3/article-26/7·chapter-iii/section-3/article-26/8·chapter-iii/section-3/article-27/1·chapter-iii/section-3/article-27/2·chapter-iii/section-4/article-31/4·chapter-iii/section-4/article-34/2·chapter-iii/section-4/article-36/8·chapter-iii/section-4/article-36/9·chapter-iii/section-5/article-40/2·chapter-iii/section-5/article-43/1·chapter-iii/section-5/article-43/4·chapter-iii/section-5/article-46/2·chapter-iii/section-5/article-46/3·chapter-iii/section-5/article-47/1·chapter-iii/section-5/article-47/2·chapter-iii/section-5/article-47/3·chapter-iii/section-5/article-48/2·chapter-iii/section-5/article-48/3·chapter-iii/section-5/article-48/4·chapter-iii/section-5/article-48/5·chapter-iii/section-5/article-49/1·chapter-iii/section-5/article-49/2·chapter-iii/section-5/article-49/3·chapter-ix/section-1/article-72/1·chapter-ix/section-1/article-72/2·chapter-ix/section-1/article-72/4·chapter-ix/section-2/article-73/4·chapter-ix/section-2/article-73/6·chapter-ix/section-3/article-74/13·chapter-ix/section-3/article-74/6·chapter-ix/section-3/article-75/3·chapter-ix/section-3/article-77/3·chapter-ix/section-3/article-79/2·chapter-ix/section-3/article-79/6·chapter-ix/section-3/article-80/1·chapter-ix/section-3/article-80/2·chapter-ix/section-3/article-80/7·chapter-ix/section-3/article-82/1·chapter-ix/section-3/article-82/3·chapter-ix/section-3/article-83/2·chapter-ix/section-4/article-86/1·chapter-vi/article-60/2·chapter-vi/article-60/4·chapter-vi/article-63/1;eu-cyber-resilience-actchapter-i/article-3·chapter-i/article-7/2·chapter-v/article-57/1;eu-digital-omnibus-aiarticle-1·article-1/3·article-1/4·article-1/5·article-1/6;eu-gmp-annex-1annex-1/11;eu-gmp-annex-111·16·4.4·6·9;eu-gmp-annex-11-draft17;eu-gmp-annex-1410;eu-gmp-annex-1511.4·12;eu-gmp-annex-162.2;eu-gmp-annex-175;eu-gmp-annex-225·36·5·8;eu-gmp-annex-215.1.1;eu-gmp-annex-2210;eu-gmp-chapter-1chapter-1;eu-gmp-chapter-2part-1;eu-gmp-chapter-3part-1;eu-gmp-chapter-5part-1;eu-gmp-chapter-6part-1;eu-gmp-chapter-8part-1;eu-ivdrannex-i/chapter-i/3·annex-i/chapter-ii·annex-ii/1.1·annex-ix/chapter-i/2.2·annex-ix/chapter-i/3.2·annex-ix/chapter-ii·annex-vi/part-a/2.1·annex-vii/3.2.6·annex-vii/4.10·annex-vii/4.5.1·annex-vii/4.8·annex-xii/chapter-i/4·chapter-i/section-1/article-2·chapter-ii/article-10/2·chapter-ii/article-10/8·chapter-ii/article-8/1·chapter-iii/article-24/12·chapter-iv/article-42/6·chapter-vii/section-1/article-78/1·chapter-vii/section-1/article-78/3·chapter-vii/section-2/article-83/1·chapter-vii/section-2/article-84/7·chapter-vii/section-2/article-84/8·chapter-vii/section-2/article-85·chapter-vii/section-3/article-95/1;eu-machinery-regulationannex-iii/part-b/5·annex-iii/part-b/6.1.1·annex-iv/part-a·annex-iv/part-b·annex-x/2·chapter-i/article-3;eu-mdrannex-i/chapter-i/3·annex-i/chapter-ii·annex-ii/1.1·annex-ix/chapter-i/2.2·annex-ix/chapter-i/3.2·annex-ix/chapter-ii·annex-vi/part-a/2.1·annex-vii/3.2.6·annex-vii/4.10·annex-vii/4.5.1·annex-vii/4.8·annex-xii/chapter-i/4·chapter-i/article-2·chapter-ii/article-10/2·chapter-ii/article-10/9·chapter-ii/article-17/3·chapter-ii/article-8/1·chapter-iii/article-27/12·chapter-iv/article-46/7·chapter-vii/section-1/article-83/1·chapter-vii/section-1/article-83/3·chapter-vii/section-2/article-88/1·chapter-vii/section-2/article-89/7·chapter-vii/section-2/article-89/8·chapter-vii/section-2/article-90·chapter-vii/section-3/article-100/1;eu-nis2chapter-i/article-2/2·chapter-i/article-6·chapter-iv/article-21/2;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;ich-q1413.2;ich-q2r2annex-2/1.2;ich-q9r125·8;nist-ai-600-112·3·9;nist-ai-rmf1.1·1.2.1·1.2.3·1.2.4·3.3·3.5·3.7·4·5·5.1·5.2·5.3·5.4·6;nistir-81836·7 - Risk Acceptance 1 clause:
ich-q9r18 - Risk Analysis 1 clause:
ich-q9r18 - Risk Assessment 4 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18;nistir-81837 - Risk Control 1 clause:
ich-q9r18 - Risk Evaluation 1 clause:
ich-q9r18 - Risk Management 19 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-111;eu-gmp-annex-11-draft17;eu-gmp-annex-162.2;eu-gmp-annex-2210;eu-gmp-chapter-1chapter-1;eu-gmp-chapter-3part-1;eu-gmp-chapter-5part-1;eu-gmp-chapter-8part-1;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;ich-q1413.2;ich-q9r18;nist-ai-600-112·3;nist-ai-rmf6;nistir-81836·7 - Risk Reduction 1 clause:
ich-q9r18 - Risk Review 1 clause:
ich-q9r18 - ropes 3 clauses:
eu-machinery-regulationannex-iii/part-b/5·annex-iii/part-b/6.1.1·chapter-i/article-3 - safety component 5 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-1/article-6/1;eu-digital-omnibus-aiarticle-1·article-1/5;eu-machinery-regulationchapter-i/article-3 - safety function 4 clauses:
eu-ai-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - sandbox plan 2 clauses:
eu-ai-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/6 - scientific validity of an analyte 1 clause:
eu-ivdrchapter-i/section-1/article-2 - security of network and information systems 2 clauses:
eu-cybersecurity-acttitle-i/article-2;eu-nis2chapter-i/article-6 - sensitive operational data 6 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-26/10·chapter-iii/section-3/article-26/5·chapter-iii/section-5/article-46/3·chapter-ix/section-1/article-72/2·chapter-vi/article-59/1 - serious adverse event 6 clauses:
eu-gmp-annex-1410;eu-gmp-annex-236;eu-ivdrchapter-i/section-1/article-2·chapter-vi/article-76/2;eu-mdrchapter-i/article-2·chapter-vi/article-80/2 - serious incident 15 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-17/1·chapter-iii/section-3/article-26/5·chapter-ix/section-2/article-73/2·chapter-ix/section-2/article-73/4·chapter-ix/section-2/article-73/6·chapter-vi/article-60/7;eu-ivdrchapter-i/section-1/article-2·chapter-vii/section-2/article-82/1·chapter-vii/section-2/article-84/7·chapter-vii/section-2/article-84/9;eu-mdrchapter-i/article-2·chapter-vii/section-2/article-87/1·chapter-vii/section-2/article-89/7·chapter-vii/section-2/article-89/9 - serious public health threat 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - significant cyber threat 1 clause:
eu-nis2chapter-i/article-6 - significant cybersecurity risk 3 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-v/article-57/1;fda-device-cybersecurity-20266 - single-use device 3 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrannex-vi/part-a/2.1·chapter-i/article-2 - small mid-cap enterprise 1 clause:
eu-digital-omnibus-aiarticle-1 - SMC 2 clauses:
eu-digital-omnibus-aiarticle-1·article-1/3 - SME 6 clauses:
eu-ai-actchapter-iii/section-2/article-11/1;eu-digital-omnibus-aiarticle-1·article-1/3;eu-gmp-annex-11-draft17;eu-gmp-annex-2210;nist-ai-rmf6 - social networking services platform 1 clause:
eu-nis2chapter-i/article-6 - software 40 clauses:
ema-annex11-concept-paper1;ema-data-quality-framework10;eu-ai-actannex-iv/1·annex-iv/2·annex-xi/section-2/3·chapter-iii/section-2/article-13/3;eu-cyber-resilience-actannex-vii·chapter-i/article-3;eu-gmp-annex-1117·3.4·4.3;eu-gmp-annex-11-draft17·17.5;eu-ivdrannex-i/chapter-ii·annex-ii/1.1·annex-ii/3.1·annex-vi/part-c/6.2.1·annex-vi/part-c/6.2.4·chapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·annex-iv/part-a·annex-iv/part-b·chapter-i/article-3;eu-mdrannex-i/chapter-ii·annex-ii/1.1·annex-vi/part-c/6.5.1·annex-vi/part-c/6.5.4·annex-viii/chapter-iii·chapter-i/article-2;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q1413.2;ich-q9r125;nist-ai-600-112·3;nist-ai-rmf1.2.1·1.2.4·5.3·6;nistir-81837 - software bill of materials 2 clauses:
eu-cyber-resilience-actannex-vii·chapter-i/article-3 - source code 6 clauses:
eu-ai-actchapter-ix/section-3/article-74/13;eu-cyber-resilience-actchapter-i/article-3;eu-machinery-regulationannex-iv/part-a·annex-iv/part-b·chapter-i/article-3;fda-device-cybersecurity-20266 - special categories of personal data 3 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-1/article-7/2;eu-digital-omnibus-aiarticle-1/3 - specimen receptacle 1 clause:
eu-ivdrchapter-i/section-1/article-2 - sponsor 41 clauses:
eu-gmp-annex-137·8;eu-gmp-chapter-8part-1;eu-ivdrchapter-i/section-1/article-2·chapter-vi/article-65/2·chapter-vi/article-66/1·chapter-vi/article-66/2·chapter-vi/article-66/3·chapter-vi/article-69/1·chapter-vi/article-70/1·chapter-vi/article-71/1·chapter-vi/article-72/3·chapter-vi/article-72/4·chapter-vi/article-73/1·chapter-vi/article-73/5·chapter-vi/article-74/1·chapter-vi/article-74/11·chapter-vi/article-74/8·chapter-vi/article-76/2·chapter-vi/article-76/3·chapter-vi/article-76/4;eu-mdrchapter-i/article-2·chapter-vi/article-69/2·chapter-vi/article-70/1·chapter-vi/article-70/2·chapter-vi/article-70/3·chapter-vi/article-73/1·chapter-vi/article-74/1·chapter-vi/article-75/1·chapter-vi/article-76/3·chapter-vi/article-76/4·chapter-vi/article-77/1·chapter-vi/article-77/5·chapter-vi/article-78/1·chapter-vi/article-78/11·chapter-vi/article-78/8·chapter-vi/article-80/2·chapter-vi/article-80/3·chapter-vi/article-80/4;fda-ai-guidance7;fda-device-cybersecurity-20266 - Stakeholder 1 clause:
nist-ai-600-112 - standard 33 clauses:
ema-data-quality-framework10;eu-ai-actchapter-i/article-3·chapter-iii/section-5/article-43/1·chapter-iv/article-50/2;eu-cyber-resilience-actannex-viii/part-iv/3.3·chapter-i/article-3;eu-cybersecurity-acttitle-i/article-2;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-1410;eu-gmp-annex-1512;eu-gmp-chapter-6part-1;eu-ivdrannex-ix/chapter-i/2.3·annex-vi/part-c/6.2.4·annex-vii/4.6·chapter-i/section-1/article-2·chapter-viii/article-100/5;eu-machinery-regulationannex-iii/part-b/5·annex-ix/3.3·chapter-i/article-3;eu-mdrannex-ix/chapter-i/2.3·annex-vi/part-c/6.5.4·annex-vii/4.6·annex-xi/part-b·chapter-i/article-2;eu-nis2chapter-i/article-6;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q1413.2;ich-q2r2annex-2/4;ich-q9r18;nist-ai-600-112;nist-ai-rmf6 - Static test 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - subject 88 clauses:
ema-annex11-concept-paper1;ema-data-quality-framework10;eu-ai-actannex-vii/2·annex-vii/4.5·chapter-i/article-3·chapter-ii/article-5/3·chapter-iii/section-1/article-6/4·chapter-iii/section-2/article-10/2·chapter-iii/section-3/article-17/4·chapter-iii/section-3/article-25/1·chapter-iii/section-3/article-25/3·chapter-iii/section-3/article-26/10·chapter-iii/section-3/article-26/11·chapter-iii/section-3/article-26/5·chapter-iii/section-3/article-26/6·chapter-iii/section-3/article-26/7·chapter-iii/section-5/article-43/4·chapter-iii/section-5/article-47/3·chapter-iii/section-5/article-48/5·chapter-iv/article-50/1·chapter-iv/article-50/3·chapter-ix/section-1/article-72/4·chapter-ix/section-3/article-80/4·chapter-ix/section-3/article-80/7·chapter-ix/section-4/article-86/1·chapter-vi/article-60/4·chapter-vi/article-61/1·chapter-xii/article-100/1·chapter-xii/article-100/3;eu-cyber-resilience-actannex-viii/part-iv/2·chapter-i/article-3;eu-digital-omnibus-aiarticle-1/3·article-1/6·article-1/8;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-138;eu-gmp-annex-1410;eu-gmp-annex-1512;eu-gmp-annex-175;eu-gmp-annex-225·36;eu-gmp-annex-2210;eu-gmp-chapter-2part-1;eu-gmp-chapter-6part-1;eu-ivdrannex-i/chapter-ii·annex-ix/chapter-i/1·annex-vi/part-c/6.2.1·annex-vii/4.9·annex-xi/1·chapter-i/section-1/article-2·chapter-ii/article-16/4·chapter-vi/article-59/2·chapter-vi/article-59/6·chapter-vi/article-74/11·chapter-vi/article-74/8·chapter-vii/section-2/article-82/1·chapter-vii/section-3/article-88/7;eu-machinery-regulationannex-iii/part-b/5·annex-ix/2;eu-mdrannex-ix/chapter-i/1·annex-vi/part-c/6.5.1·annex-vii/4.9·annex-xi/part-a·annex-xi/part-b·chapter-i/article-2·chapter-ii/article-16/4·chapter-ii/article-22/2·chapter-ii/article-22/4·chapter-vi/article-63/2·chapter-vi/article-63/6·chapter-vi/article-78/11·chapter-vi/article-78/8·chapter-vii/section-2/article-87/1·chapter-vii/section-3/article-93/7;eu-nis2chapter-i/article-6;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;ich-q1413.2;ich-q9r18;nist-ai-600-112·3·9;nist-ai-rmf3·3.4·5.3·6 - substantial modification 7 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-2/article-12/2·chapter-iii/section-3/article-25/1·chapter-iii/section-5/article-43/4·chapter-x/article-96/1;eu-cyber-resilience-actchapter-i/article-3;eu-machinery-regulationchapter-i/article-3 - Supervisor 5 clauses:
eu-ai-actchapter-i/article-3·chapter-vi/article-58/2·chapter-xii/article-100/1;eu-digital-omnibus-aiarticle-1/6;eu-machinery-regulationannex-iii/part-b/5 - Supervisory function 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - support period 4 clauses:
eu-cyber-resilience-actannex-vii·annex-viii/part-iv/2·annex-viii/part-iv/6·chapter-i/article-3 - Surgically invasive device 1 clause:
eu-mdrannex-viii/chapter-i/2 - systemic risk 2 clauses:
eu-ai-actchapter-i/article-3;eu-nis2chapter-i/article-2/2 - technical specification 3 clauses:
eu-cyber-resilience-actannex-viii/part-iv/3.3;eu-cybersecurity-acttitle-i/article-2;eu-nis2chapter-i/article-6 - technical specifications 10 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-17/1·chapter-x/article-96/1;eu-cyber-resilience-actannex-vii·annex-viii/part-iv/3.2;eu-machinery-regulationannex-iv/part-a·annex-iv/part-b·annex-ix/3.2·chapter-i/article-3;eu-mdrannex-ii/1.1 - Test coefficient 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - testing data 7 clauses:
eu-ai-actannex-iv/2·chapter-i/article-3·chapter-iii/section-2/article-10/2·chapter-iii/section-2/article-10/3·chapter-iii/section-2/article-13/3;eu-digital-omnibus-aiarticle-1/3;eu-gmp-annex-1annex-1/11 - testing in real-world conditions 3 clauses:
eu-ai-actchapter-i/article-3·chapter-vi/article-60/4;eu-digital-omnibus-aiarticle-1/6 - TLD name registry 1 clause:
eu-nis2chapter-i/article-6 - top-level domain name registry 1 clause:
eu-nis2chapter-i/article-6 - training data 12 clauses:
eu-ai-actannex-iv/2·chapter-i/article-3·chapter-iii/section-2/article-15/5;eu-gmp-annex-2210·10.5;fda-ai-guidance7;nist-ai-600-112·3·6·9;nist-ai-rmf3.3·3.4 - Trend 1 clause:
eu-gmp-chapter-6part-1 - trust service 2 clauses:
eu-nis2chapter-i/article-2/2·chapter-i/article-6 - trust service provider 1 clause:
eu-nis2chapter-i/article-6 - UDI 36 clauses:
eu-ivdrannex-ii/1.1·annex-vi/part-a/2.1·annex-vi/part-c/6.2.1·annex-vi/part-c/6.2.4·annex-xii/chapter-i/4·chapter-i/section-1/article-2·chapter-ii/article-10/6·chapter-ii/article-10/8·chapter-iii/article-24/1·chapter-iii/article-24/11·chapter-iii/article-24/12·chapter-iii/article-24/2·chapter-iii/article-30/2·chapter-vii/section-2/article-87/1·chapter-x/article-113/3;eu-mdrannex-ii/1.1·annex-vi/part-a/2.1·annex-vi/part-c/6.3.1·annex-vi/part-c/6.3.2·annex-vi/part-c/6.3.3·annex-vi/part-c/6.4.4·annex-vi/part-c/6.5.1·annex-vi/part-c/6.5.4·annex-xii/chapter-i/4·chapter-i/article-2·chapter-ii/article-10/7·chapter-ii/article-10/9·chapter-iii/article-27/1·chapter-iii/article-27/11·chapter-iii/article-27/12·chapter-iii/article-27/2·chapter-iii/article-29/2·chapter-iii/article-33/2·chapter-vii/section-2/article-92/1·chapter-x/article-123/3;fda-device-cybersecurity-20266 - Union harmonisation legislation 19 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-1/article-6/1·chapter-iii/section-2/article-11/2·chapter-iii/section-2/article-8/2·chapter-iii/section-3/article-25/3·chapter-iii/section-5/article-40/2·chapter-iii/section-5/article-47/3·chapter-ix/section-1/article-72/4·chapter-ix/section-3/article-79/2·chapter-x/article-96/1;eu-cyber-resilience-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1·article-1/5·article-1/6;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·annex-iv/part-a·chapter-i/article-3;eu-mdrchapter-i/article-2 - Unique Device Identifier 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - Unit Operation 1 clause:
ich-q1413.2 - user 40 clauses:
ema-annex11-concept-paper1;eu-ai-actannex-iv/1;eu-cyber-resilience-actannex-vii;eu-digital-omnibus-aiarticle-1/3;eu-gmp-annex-1annex-1/11;eu-gmp-annex-114.5;eu-gmp-annex-11-draft17·17.5;eu-gmp-annex-1512·3.1;eu-gmp-annex-2210;eu-ivdrannex-i/chapter-ii·annex-ii/1.1·annex-ix/chapter-ii·annex-vi/part-c/6.2.4·chapter-i/section-1/article-2·chapter-vi/article-59/6·chapter-vi/article-69/5·chapter-vi/article-73/5;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrannex-i/chapter-ii·annex-ii/1.1·annex-ix/chapter-ii·annex-vi/part-c/6.5.4·chapter-i/article-2·chapter-vi/article-63/6·chapter-vi/article-73/5·chapter-vi/article-77/5;eu-nis2chapter-i/article-6;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-600-112·3;nist-ai-rmf3.4·3.5·5·5.2·6;nistir-81837 - validation data 4 clauses:
eu-ai-actchapter-i/article-3;ich-q124;ich-q1413.2;ich-q2r2annex-2/2 - validation data set 1 clause:
eu-ai-actchapter-i/article-3 - vulnerability 10 clauses:
eu-cyber-resilience-actannex-vii·annex-viii/part-iv/2·annex-viii/part-iv/3.2·chapter-i/article-3;eu-gmp-annex-11-draft17;eu-nis2chapter-i/article-6·chapter-iv/article-21/2;fda-device-cybersecurity-20266;nist-ai-600-112;nistir-81837 - webbing 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - widespread infringement 1 clause:
eu-ai-actchapter-i/article-3 - withdrawal 20 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-4/article-36/9·chapter-iii/section-5/article-45/1·chapter-ix/section-3/article-79/9·chapter-ix/section-3/article-81/2;eu-cyber-resilience-actchapter-i/article-3·chapter-v/article-57/1;eu-gmp-annex-1410;eu-ivdrannex-vii/4.8·chapter-i/section-1/article-2·chapter-iv/article-42/6·chapter-iv/article-43/4·chapter-v/section-2/article-52;eu-machinery-regulationchapter-i/article-3·chapter-v/article-40/1;eu-mdrannex-vii/4.8·chapter-i/article-2·chapter-iv/article-46/7·chapter-iv/article-47/4·chapter-v/section-2/article-57/1 - withdrawal of an AI system 1 clause:
eu-ai-actchapter-i/article-3 - Working coefficient 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - written 45 clauses:
eu-ai-actannex-vii/3.1·chapter-i/article-3·chapter-iii/section-3/article-17/1·chapter-iii/section-3/article-25/4·chapter-iii/section-5/article-47/1·chapter-vi/article-57/7;eu-cyber-resilience-actannex-viii/part-iv/3.1·annex-viii/part-iv/3.2·chapter-i/article-3;eu-digital-omnibus-aiarticle-1/4·article-1/6;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-132·7;eu-gmp-annex-1410;eu-gmp-annex-161.5.5·2.2;eu-gmp-annex-236;eu-gmp-chapter-1chapter-1;eu-gmp-chapter-2part-1;eu-gmp-chapter-3part-1;eu-gmp-chapter-5part-1;eu-gmp-chapter-6part-1;eu-gmp-chapter-8part-1;eu-ivdrannex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-vii/4.3·annex-xi/3.2·chapter-i/section-1/article-2·chapter-iv/article-42/6;eu-machinery-regulationannex-iii/part-b/5·annex-ix/3.1·annex-ix/3.2·annex-x/2·chapter-i/article-3;eu-mdrannex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-ix/chapter-ii·annex-vii/4.3·annex-xi/part-a·chapter-i/article-2;ich-q124;nist-ai-600-112·3
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17bed942038f unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
6d68d146b07c (current) | 0 | 16 | 4 |
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90f72782b398 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
ebaf707c409d (current) | 0 | 108 | 48 |
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e2ad4536a9bd unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
4d30b7bae7dd (current) | 0 | 4 | 18 |
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08b4462d76fa unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
acd195a087c3 (current) | 0 | 0 | 1 |
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208b17ec5cbe | 0 | 0 | 4 | |
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| First observed | Text | Defined | In normative sentences | In body |
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58dbc3006d27 | 0 | 302 | 133 | |
9d16077b1d3b (current) | 0 | 302 | 133 |
| First observed | Text | Defined | In normative sentences | In body |
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9206a43954eb (current) | 0 | 33 | 9 |
| First observed | Text | Defined | In normative sentences | In body |
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1fe6027daa2c (current) | 0 | 4 | 5 |
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92eb86f25281 (current) | 0 | 45 | 24 |
| First observed | Text | Defined | In normative sentences | In body |
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2f3d52a59156 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
1d99797d3b8b (current) | 0 | 63 | 20 |
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1bf6c7c62112 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
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50a728365a3b unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
db59da980bed (current) | 0 | 8 | 5 |
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c69969906e63 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
2f7bb1a97c67 (current) | 0 | 5 | 0 |
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d15b6167fee9 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
507358780b13 (current) | 0 | 5 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
053f731102ad unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
c1a1d8a7fee4 (current) | 0 | 9 | 3 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
45769b002c01 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
6e2055f21776 (current) | 0 | 3 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
797a882ba0ea | 0 | 0 | 2 | |
07dc6a9975d1 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
f8b98469078e (current) | 0 | 5 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
2cb8ccdb053c unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
743cfcdd11a7 (current) | 0 | 4 | 2 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
10131cf8966a unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
1787513e049d (current) | 0 | 3 | 6 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
e6dfb22ae579 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
fd6b0dfbb7fd (current) | 0 | 1 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
04e1593f805c unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
1be3d183419f (current) | 0 | 2 | 3 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
0c75116285b8 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
cfea967f8325 (current) | 0 | 10 | 9 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
6d54bcfeb8e7 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
313242556edd (current) | 0 | 5 | 3 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
dccc2d038791 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
c0432468bd32 (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
ef49f58a80fe unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
b9143ae11461 (current) | 0 | 7 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
85a680107f4d unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
8f04120f403b (current) | 0 | 27 | 6 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
f30eb798ed40 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
172395cf624f (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
2ebf88652dc3 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
6ec505fc00ef (current) | 0 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
723340abc9bd unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
d5d92da2b929 (current) | 0 | 2 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
6af0146c0d0b unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
880033e05d95 (current) | 0 | 2 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
903e40aaebe6 (current) | 0 | 178 | 19 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
1fc20ae2ffd8 | 0 | 48 | 4 | |
82fb682a6c54 (current) | 0 | 48 | 4 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
14d00b77d5c8 | 1 | 191 | 27 | |
fab624c8e1dc (current) | 1 | 191 | 27 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
023dc18395dc (current) | 0 | 13 | 12 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
61d4603ff66e | 0 | 0 | 0 | |
088a7a37c55d | 0 | 0 | 0 | |
630bd27c7b42 | 0 | 0 | 0 | |
5c61f4c6351d (current) | 0 | 4 | 4 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
7d8bfb6d13ca | 0 | 0 | 269 | |
a55b6f369034 | 0 | 0 | 285 | |
f0d90446093e (current) | 0 | 0 | 285 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
4843091843f0 (current) | 0 | 0 | 5 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
b52b706d5cca (current) | 0 | 0 | 3 | |
d34d8c706d88 | 0 | 50 | 87 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
b52b706d5cca | 0 | 0 | 3 | |
27c5d1a28e3d unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
d34d8c706d88 (current) | 0 | 50 | 87 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
06b24bf9ebcb unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
74c586849092 (current) | 0 | 28 | 21 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
b970b2dbbcaa unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
60a8c7bb10cf (current) | 0 | 0 | 4 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
f5e8806992b5 | 0 | 0 | 0 | |
ae6842a2cdd8 (current) | 0 | 0 | 2 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
a5590943862c (current) | 0 | 3 | 11 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
206fc2d61445 (current) | 0 | 12 | 13 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
06273204f50b (current) | 1 | 22 | 54 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
5e9388123e17 (current) | 0 | 1 | 17 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
bb656b9e84a8 (current) | 0 | 0 | 8 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
57c484f5daed (current) | 0 | 3 | 23 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
7337fc5e71ae | 0 | 0 | 0 | |
6e98d69dcbc7 | 0 | 0 | 0 | |
5ccba04e90a2 | 0 | 0 | 0 | |
aa1a23f2db97 | 0 | 0 | 0 | |
dd2f48968ac3 | 0 | 0 | 0 | |
6f27b489239b | 0 | 0 | 0 | |
d1d2dd4818e2 | 0 | 0 | 0 | |
a16f7063df22 | 0 | 0 | 0 | |
53985e50d069 | 0 | 0 | 0 | |
2cf39acc83b7 | 0 | 0 | 1 | |
0465b20f61c7 (current) | 0 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
c330704e7caa | 0 | 0 | 2 | |
13971812bd57 | 0 | 0 | 2 | |
6903993ae01b | 0 | 0 | 2 | |
aadc8bf62498 | 0 | 0 | 2 | |
9a0948cb5e5b | 0 | 0 | 2 | |
5f23d775ccaa | 0 | 0 | 2 | |
f4ddeaad589b | 0 | 0 | 2 | |
fe6722320c02 | 0 | 0 | 2 | |
ced856cd0b5a | 0 | 0 | 2 | |
c59c1f4d8377 (current) | 0 | 0 | 2 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
c0ab0e6263b3 | 0 | 0 | 0 | |
edcebd0e3a36 | 0 | 0 | 0 | |
9d19d28e1a57 | 0 | 0 | 0 | |
f2734caa33bb | 0 | 0 | 0 | |
8727e7836a62 | 0 | 0 | 0 | |
e6bfd1f64b25 | 0 | 0 | 1 | |
67d33a19b1a7 | 0 | 0 | 1 | |
05c0bdbc196e | 0 | 0 | 1 | |
8e07db344887 | 0 | 0 | 1 | |
84a3e0382b0e | 0 | 0 | 1 | |
6f9c326c480f | 0 | 0 | 1 | |
b413d56295e8 | 0 | 0 | 1 | |
e3d94d289c0b | 0 | 0 | 1 | |
d800e5bf4d9b (current) | 0 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
a5ad5867c187 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
caa03fc84948 (current) | 0 | 18 | 120 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
8afebcc0941a | 0 | 0 | 0 | |
c240f2675bd3 | 0 | 0 | 0 | |
4c10dc03228b (current) | 0 | 16 | 86 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
eae63eec79c3 | 0 | 0 | 2 | |
3e7e350389ef (current) | 0 | 0 | 2 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
92b7bfe588c4 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
fe392d207918 (current) | 0 | 7 | 278 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
f0554d5c3fab | 0 | 6 | 5 | |
6a4d277ca4f8 | 0 | 6 | 5 | |
95bf4a66f2d4 | 0 | 6 | 5 | |
98ed07f87cdd | 0 | 6 | 5 | |
15f94377c4fc | 0 | 6 | 5 | |
9269c75204ff | 0 | 6 | 5 | |
4d93ac00b602 | 0 | 6 | 5 | |
825750c5633d | 0 | 6 | 5 | |
39db0dd17f53 | 0 | 6 | 5 | |
244eba4196bb | 0 | 6 | 5 | |
605180a389c7 | 0 | 6 | 5 | |
ed1c9acbb776 | 0 | 6 | 5 | |
bbbd805d0905 (current) | 0 | 6 | 4 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
393b48f902b8 | 0 | 16 | 2 | |
5997ebbb6661 | 0 | 16 | 2 | |
9d7b6d9aa4e1 | 0 | 16 | 2 | |
18e04a0c925a | 0 | 16 | 2 | |
1e7f13684129 | 0 | 16 | 2 | |
f24b92ecdf42 | 0 | 16 | 2 | |
b670ac9656b7 | 0 | 16 | 2 | |
bc527e48bcd8 | 0 | 16 | 2 | |
4edb9480421c | 0 | 16 | 2 | |
cd3e1c0c936b | 0 | 16 | 2 | |
75605421c92f (current) | 0 | 16 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
8b8ac787c687 | 0 | 2 | 9 | |
fa65ecef3a81 | 0 | 2 | 9 | |
8ee8e1aad0a5 | 0 | 2 | 9 | |
f3605b69e136 | 0 | 2 | 9 | |
baa155d883e3 | 0 | 2 | 9 | |
ac6e97a3c75d | 0 | 2 | 9 | |
bb66b9cbb2c4 | 0 | 2 | 9 | |
0e1bbcb2d14d | 0 | 2 | 9 | |
0eb9eade1868 | 0 | 2 | 9 | |
94a77d5625e8 | 0 | 2 | 9 | |
ca64082d7f23 (current) | 0 | 2 | 8 |
Feed
/atom/term/system.atom carries one entry for each text of a row whose counts above differ from the row’s previous text, and one for the first text of a row holding the term, dated by the text’s first observation. A new version of the derivation is a change of method and is never an entry.
How this page is derived
From the terms-index derivation’s current version, first derived on
, read from
state/terms-index.jsonl. Threshold: a key enters the index when at least 1 observed text of a tracked row defines it, under the definitions derivation's current version. Its version, its rules and
term set, and the versions of the clause-anchor, definitions and sentence derivations it joins, are on
the derivation methods page, which lists every version of each with
the day it was first derived: a change there is a change of method, never a change in a text.
Not read: a term printed in a form no definition under its key carries: a plural or other ending, another letter case, another spacing or a line break between its words, a hyphenated or abbreviated form, a translation; a term a document defines in a form head 3's rules do not read (its own not_reached names them), which enters no key; an occurrence in a text head 1 refused, which is not read; a title is read for its row and is not dated by a text. A position states where an occurrence lies in a text and nothing about what the text says of the term.
| Entry | text_retained | licence_class | quote_allowed | snapshot_available |
|---|---|---|---|---|
| EU MDR | true | open | true | true |
| ICH Q13 | true | open | true | true |
| EU IVDR | true | open | true | true |
| EU Cybersecurity Act | true | open | true | true |
| EU Machinery Regulation | true | open | true | true |
| 21 CFR Part 11 | true | open | true | true |
| EU Cyber Resilience Act | true | open | true | true |
| EU AI Act | true | open | true | true |
| EU GMP Annex 22 | true | open | true | true |
| FDA device cybersecurity | true | open | true | true |
| FDA device cybersecurity (2026) | true | open | true | true |
| EU GMP Annex 11 | true | open | true | true |
| FDA electronic systems (clinical) | true | open | true | true |
| EU NIS2 Directive | true | open | true | true |
| 21 CFR Part 820 (QMSR) | true | open | true | true |
| ICH Q9(R1) | true | open | true | true |
| Regulation (EU) 2026/1744 | true | open | true | true |
| EU GMP Chapter 4 | true | open | true | true |
One row for each entry whose own characters this page prints: a text defining a form printed here, or a definition quoted. A row named or linked without its characters printed, or whose title only or sentence clauses only are given, has no row.
Each value is read by the same function the API reads, and each field is defined in the published schema. None of the four is a grant.
Last updated: