Risk / risk
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 6 definitions in this view are quoted and 6 are withheld with the reason. No reading here says that two of them agree or differ.
Canada
- 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
- 1
EU
- Defined in
- EU AI Act
chapter-i/article-3(2): text withheld (over the cap: its term and text are 18 words)EU IVDRchapter-i/section-1/article-2(16): text withheld (over the cap: its term and text are 17 words)EU Machinery Regulationannex-iii/part-a(e): text withheld (over the cap: its term and text are 24 words)EU MDRchapter-i/article-2(23): text withheld (over the cap: its term and text are 17 words)EU NIS2 Directivechapter-i/article-6(9): text withheld (over the cap: its term and text are 36 words) - Rows printing it in a normative sentence
- 34
- Rows printing it in a title
- 0
- Rows printing it in body
- 26
International
- Defined in
- ICH Q9(R1)no clause given: text withheld (over the cap: its term and text are 19 words)
- Rows printing it in a normative sentence
- 7
- Rows printing it in a title
- 5
- Rows printing it in body
- 9
US
- Defined in
- no current text of a row of this jurisdiction defines it
- Rows printing it in a normative sentence
- 8
- Rows printing it in a title
- 0
- Rows printing it in body
- 13
These forms are printed by the
tracked documents, each as a document defines it. The index’s key is
risk (the definitions derivation’s fold:
case set aside, spaces collapsed; each form is matched exactly as printed).
9 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
6 definitions in 6 current texts, as the definitions derivation’s rules read them, quoted where the term and its text together sit under the quote cap.
- EU AI Act
EUtext first observedchapter-i/article-3(2)risk: text withheld (over the cap: its term and text are 18 words)
- EU IVDR
EUtext first observedchapter-i/section-1/article-2(16)risk: text withheld (over the cap: its term and text are 17 words)
- EU Machinery Regulation
EUtext first observedannex-iii/part-a(e)risk: text withheld (over the cap: its term and text are 24 words)
- EU MDR
EUtext first observedchapter-i/article-2(23)risk: text withheld (over the cap: its term and text are 17 words)
- EU NIS2 Directive
EUtext first observedchapter-i/article-6(9)risk: text withheld (over the cap: its term and text are 36 words)
- ICH Q9(R1)
Internationaltext first observed- no clause given (its definitions section's heading carries no number the clause anchors placed) Risk: text withheld (over the cap: its term and text are 19 words)
In normative sentences
1407 sentences in 49 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
EU3 sentences; text first observed1: 3 sentences (should, may) - EMA CT computerised systems
EU31 sentences; text first observedid repeats in this text: 1 sentence (should) · follows a withheld heading: 13 sentences (should, may) · id repeats in this text: 17 sentences (should, may, is expected) - Annex 15 revision concept paper
International2 sentences; text first observed1: 1 sentence (should) ·6: 1 sentence (should) - EU AI Act
EU363 sentences; text first observedno clause anchor before this sentence: 132 sentences (should, may) ·chapter-i/article-3: 1 sentence (may, shall) ·chapter-ii/article-5/1: 1 sentence (shall) ·chapter-iii/section-1/article-6/1: 1 sentence (shall) ·chapter-iii/section-1/article-6/2: 1 sentence (shall) ·chapter-iii/section-1/article-6/3: 2 sentences (shall) ·chapter-iii/section-1/article-6/4: 1 sentence (shall) ·chapter-iii/section-1/article-6/5: 1 sentence (shall) ·chapter-iii/section-2/article-8/1: 2 sentences (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-9/4: 1 sentence (shall) ·chapter-iii/section-2/article-9/5: 3 sentences (shall) ·chapter-iii/section-2/article-9/6: 2 sentences (shall) ·chapter-iii/section-2/article-9/8: 2 sentences (shall) ·chapter-iii/section-2/article-9/9: 1 sentence (shall) ·chapter-iii/section-2/article-9/10: 1 sentence (may) ·chapter-iii/section-2/article-10/1: 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-10/5: 1 sentence (may) ·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-13/2: 1 sentence (shall) ·chapter-iii/section-2/article-13/3: 1 sentence (shall, may) ·chapter-iii/section-2/article-14/1: 1 sentence (shall) ·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: 2 sentences (shall) ·chapter-iii/section-2/article-15/1: 1 sentence (shall) ·chapter-iii/section-2/article-15/3: 1 sentence (shall) ·chapter-iii/section-2/article-15/4: 3 sentences (shall, may) ·chapter-iii/section-2/article-15/5: 2 sentences (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-17/2: 1 sentence (shall) ·chapter-iii/section-3/article-17/3: 1 sentence (may) ·chapter-iii/section-3/article-18/1: 1 sentence (shall) ·chapter-iii/section-3/article-19/1: 2 sentences (shall) ·chapter-iii/section-3/article-19/2: 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-22/1: 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: 2 sentences (shall, may) ·chapter-iii/section-3/article-26/1: 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: 2 sentences (shall) ·chapter-iii/section-3/article-26/9: 1 sentence (shall) ·chapter-iii/section-3/article-26/10: 4 sentences (shall) ·chapter-iii/section-3/article-26/11: 2 sentences (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: 3 sentences (shall) ·chapter-iii/section-4/article-31/5: 1 sentence (shall) ·chapter-iii/section-4/article-34/1: 1 sentence (shall) ·chapter-iii/section-4/article-34/2: 2 sentences (shall) ·chapter-iii/section-4/article-36/3: 2 sentences (may, shall) ·chapter-iii/section-4/article-36/7: 1 sentence (shall) ·chapter-iii/section-4/article-36/8: 1 sentence (shall) ·chapter-iii/section-4/article-36/9: 1 sentence (shall) ·chapter-iii/section-4/article-38/1: 1 sentence (shall) ·chapter-iii/section-5/article-40/1: 1 sentence (shall) ·chapter-iii/section-5/article-40/2: 2 sentences (shall) ·chapter-iii/section-5/article-41/3: 1 sentence (shall) ·chapter-iii/section-5/article-41/5: 1 sentence (shall) ·chapter-iii/section-5/article-42/1: 1 sentence (shall) ·chapter-iii/section-5/article-42/2: 1 sentence (shall) ·chapter-iii/section-5/article-43/1: 3 sentences (shall) ·chapter-iii/section-5/article-43/2: 1 sentence (shall) ·chapter-iii/section-5/article-43/3: 3 sentences (shall) ·chapter-iii/section-5/article-43/4: 2 sentences (shall) ·chapter-iii/section-5/article-46/1: 1 sentence (may) ·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-46/7: 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: 2 sentences (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-iii/section-5/article-49/4: 1 sentence (shall) ·chapter-iii/section-5/article-49/5: 1 sentence (shall) ·chapter-v/section-1/article-51/1: 1 sentence (shall) ·chapter-v/section-1/article-52/1: 1 sentence (may) ·chapter-v/section-1/article-52/2: 1 sentence (may, should) ·chapter-v/section-1/article-52/3: 1 sentence (shall) ·chapter-v/section-1/article-52/5: 2 sentences (shall, may) ·chapter-v/section-1/article-52/6: 1 sentence (shall) ·chapter-v/section-3/article-55/1: 1 sentence (shall, may) ·chapter-v/section-3/article-55/2: 1 sentence (may) ·chapter-vi/article-60/1: 2 sentences (may, shall) ·chapter-vi/article-60/2: 1 sentence (may) ·chapter-vi/article-60/3: 1 sentence (shall) ·chapter-vi/article-60/4: 1 sentence (may, shall) ·chapter-vi/article-60/6: 1 sentence (shall) ·chapter-vi/article-63/1: 1 sentence (shall, may) ·chapter-vii/section-1/article-68/3: 1 sentence (shall) ·chapter-viii/article-71/1: 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-72/4: 2 sentences (shall) ·chapter-ix/section-2/article-73/1: 1 sentence (shall) ·chapter-ix/section-2/article-73/4: 1 sentence (shall) ·chapter-ix/section-2/article-73/6: 1 sentence (shall) ·chapter-ix/section-2/article-73/9: 1 sentence (shall) ·chapter-ix/section-2/article-73/10: 1 sentence (shall) ·chapter-ix/section-3/article-74/3: 1 sentence (shall) ·chapter-ix/section-3/article-74/6: 1 sentence (shall) ·chapter-ix/section-3/article-74/8: 1 sentence (shall) ·chapter-ix/section-3/article-74/10: 1 sentence (shall) ·chapter-ix/section-3/article-74/11: 1 sentence (shall) ·chapter-ix/section-3/article-74/12: 1 sentence (shall) ·chapter-ix/section-3/article-74/13: 1 sentence (shall) ·chapter-ix/section-3/article-75/2: 1 sentence (shall) ·chapter-ix/section-3/article-75/3: 2 sentences (may, shall) ·chapter-ix/section-3/article-77/1: 1 sentence (shall) ·chapter-ix/section-3/article-77/3: 1 sentence (may) ·chapter-ix/section-3/article-78/2: 1 sentence (shall) ·chapter-ix/section-3/article-78/3: 2 sentences (shall) ·chapter-ix/section-3/article-79/1: 1 sentence (shall) ·chapter-ix/section-3/article-79/2: 2 sentences (shall) ·chapter-ix/section-3/article-79/6: 2 sentences (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-80/7: 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-ix/section-5/article-90/1: 1 sentence (may) ·chapter-ix/section-5/article-90/3: 1 sentence (shall) ·chapter-ix/section-5/article-92/1: 1 sentence (may) ·chapter-ix/section-5/article-93/1: 1 sentence (may) ·chapter-ix/section-5/article-93/3: 1 sentence (may) ·chapter-x/article-95/1: 1 sentence (shall) ·chapter-xii/article-101/1: 1 sentence (may) ·chapter-xiii/article-111/2: 2 sentences (shall) ·chapter-xiii/article-112/7: 1 sentence (shall) ·chapter-xiii/article-112/11: 1 sentence (shall) ·annex-vii/4.5: 1 sentence (shall) ·annex-viii: 1 sentence (shall) ·annex-viii/12: 1 sentence (shall) ·annex-viii/13: 2 sentences (shall) ·annex-ix: 1 sentence (shall) ·annex-xi/section-1: 1 sentence (shall) ·annex-xiii: 1 sentence (shall) - EU Cyber Resilience Act
EU73 sentences; text first observedno clause anchor before this sentence: 36 sentences (should, may, is expected) ·chapter-i/article-3: 1 sentence (may) ·chapter-i/article-7/3: 1 sentence (shall) ·chapter-i/article-8/1: 1 sentence (shall) ·chapter-i/article-12/1: 1 sentence (shall) ·chapter-i/article-12/2: 1 sentence (shall) ·chapter-i/article-12/3: 1 sentence (shall) ·chapter-ii/article-13/3: 3 sentences (shall, is expected) ·chapter-ii/article-13/4: 2 sentences (shall, may) ·chapter-ii/article-13/7: 1 sentence (shall) ·chapter-ii/article-14/8: 1 sentence (shall) ·chapter-ii/article-15/1: 1 sentence (may) ·chapter-ii/article-16/2: 1 sentence (shall) ·chapter-ii/article-19/3: 2 sentences (shall, may) ·chapter-ii/article-19/5: 1 sentence (shall) ·chapter-ii/article-20/3: 1 sentence (shall) ·chapter-ii/article-20/4: 1 sentence (shall) ·chapter-iii/article-30/3: 1 sentence (may) ·chapter-iv/article-47/2: 1 sentence (shall) ·chapter-v/article-52/14: 1 sentence (shall) ·chapter-v/article-54/1: 2 sentences (shall, may) ·chapter-v/article-54/2: 2 sentences (shall) ·chapter-v/article-54/6: 1 sentence (shall) ·chapter-v/article-56/1: 2 sentences (shall, may) ·chapter-v/article-56/2: 2 sentences (shall) ·chapter-v/article-56/5: 1 sentence (may) ·chapter-v/article-57/1: 1 sentence (shall) ·chapter-v/article-57/3: 1 sentence (shall) ·chapter-v/article-57/9: 1 sentence (may) ·annex-i/part-i: 1 sentence (shall) - EU Cybersecurity Act
EU19 sentences; text first observedno clause anchor before this sentence: 10 sentences (should) ·title-ii/chapter-ii/article-5: 1 sentence (shall) ·title-ii/chapter-ii/article-8/5: 1 sentence (shall) ·title-ii/chapter-ii/article-11: 1 sentence (shall) ·title-iii/article-47/3: 1 sentence (shall) ·title-iii/article-52/1: 1 sentence (shall) ·title-iii/article-52/4: 1 sentence (shall) ·title-iii/article-52/6: 1 sentence (shall) ·title-iii/article-52/7: 1 sentence (shall) ·title-iii/article-53/1: 1 sentence (shall) - Regulation (EU) 2026/1744
EU52 sentences; text first observedno clause anchor before this sentence: 22 sentences (should, may) ·article-1: 4 sentences (shall, may) ·article-1/3: 7 sentences (may, shall) ·article-1/4: 1 sentence (shall) ·article-1/5: 5 sentences (shall) ·article-1/6: 7 sentences (may, shall) ·article-1/9: 4 sentences (shall, may) ·article-3: 2 sentences (shall) - EU GMP Annex 1
EU77 sentences; text first observedannex-1/11: 77 sentences (should, may, must) - EU GMP Annex 11
EU9 sentences; text first observedno clause anchor before this sentence: 1 sentence (should) ·1: 2 sentences (should) ·3.2: 1 sentence (should) ·4.1: 1 sentence (should) ·4.4: 1 sentence (should) ·6: 1 sentence (should) ·9: 1 sentence (should) ·16: 1 sentence (should) - EU GMP Annex 11 (draft)
EU21 sentences; text first observed17: 21 sentences (should) - EU GMP Annex 12
EU1 sentence; text first observed28: 1 sentence (may) - EU GMP Annex 13
EU5 sentences; text first observedno clause anchor before this sentence: 1 sentence (may) ·1: 1 sentence (shall) ·4: 2 sentences (should) ·6.5: 1 sentence (must) - EU GMP Annex 14
EU8 sentences; text first observed10: 8 sentences (should, must, may) - EU GMP Annex 15
EU16 sentences; text first observedno clause anchor before this sentence: 2 sentences (should) ·1.7: 3 sentences (should) ·5.7: 1 sentence (should) ·5.12: 1 sentence (should) ·5.16: 1 sentence (may) ·5.19: 1 sentence (should) ·6.3: 1 sentence (should) ·8.3: 1 sentence (should, may) ·10.6: 2 sentences (should) ·10.7: 1 sentence (should) ·10.13: 1 sentence (should) ·11.4: 1 sentence (should) - EU GMP Annex 16
EU7 sentences; text first observed1.5.6: 1 sentence (should) ·1.5.7: 1 sentence (may) ·1.7.2: 1 sentence (should) ·2.2: 2 sentences (should) ·3.1: 2 sentences (should) - EU GMP Annex 17
EU7 sentences; text first observed5: 7 sentences (should, may) - EU GMP Annex 19
EU1 sentence; text first observed9.2: 1 sentence (should) - EU GMP Annex 2
EU14 sentences; text first observed5: 3 sentences (should, must) ·8: 1 sentence (may, should) ·11: 1 sentence (should, may) ·17: 2 sentences (must) ·25: 1 sentence (should) ·30: 1 sentence (should) ·31: 1 sentence (may, should) ·32: 1 sentence (must) ·36: 3 sentences (should) - EU GMP Annex 21
EU1 sentence; text first observed5.1.1: 1 sentence (should) - EU GMP Annex 22
EU2 sentences; text first observed10: 2 sentences (should) - EU GMP Annex 3
EU6 sentences; text first observed12: 1 sentence (should) ·17: 2 sentences (should) ·26: 1 sentence (may) ·34: 1 sentence (should) ·48: 1 sentence (shall) - EU GMP Annex 6
EU3 sentences; text first observed8: 1 sentence (should) ·11: 1 sentence (should) ·12: 1 sentence (should) - EU GMP Annex 9
EU1 sentence; text first observed4: 1 sentence (should) - EU GMP Chapter 1
EU5 sentences; text first observedchapter-1: 5 sentences (must, should) - EU GMP Chapter 2
EU1 sentence; text first observedpart-1: 1 sentence (should, must) - EU GMP Chapter 3
EU7 sentences; text first observedpart-1: 7 sentences (must, should, may) - EU GMP Chapter 4 (draft)
EU30 sentences; text first observedno numbering read: 30 sentences (should, may) - EU GMP Chapter 5
EU13 sentences; text first observedpart-1: 13 sentences (should, may) - EU GMP Chapter 6
EU5 sentences; text first observedpart-1: 5 sentences (should, may) - EU GMP Chapter 7
EU1 sentence; text first observedno numbering read: 1 sentence (should) - EU GMP Chapter 8
EU15 sentences; text first observedpart-1: 15 sentences (should, may) - EU IVDR
EU101 sentences; text first observedno clause anchor before this sentence: 12 sentences (should, may) ·chapter-i/section-1/article-2: 2 sentences (shall, may) ·chapter-ii/article-7: 1 sentence (shall, may) ·chapter-ii/article-8/1: 1 sentence (shall) ·chapter-ii/article-10/2: 1 sentence (shall) ·chapter-ii/article-10/8: 2 sentences (shall) ·chapter-ii/article-10/11: 1 sentence (shall) ·chapter-ii/article-10/15: 1 sentence (shall) ·chapter-ii/article-13/2: 1 sentence (shall) ·chapter-ii/article-13/7: 1 sentence (shall) ·chapter-ii/article-14/2: 1 sentence (shall) ·chapter-ii/article-14/4: 1 sentence (shall) ·chapter-ii/article-18/4: 1 sentence (may) ·chapter-iii/article-24/12: 1 sentence (shall) ·chapter-iv/article-41/2: 1 sentence (shall) ·chapter-iv/article-42/6: 1 sentence (shall) ·chapter-v/section-2/article-48/13: 1 sentence (may) ·chapter-vi/article-56/1: 1 sentence (shall) ·chapter-vi/article-58/5: 1 sentence (may) ·chapter-vi/article-60/1: 1 sentence (may) ·chapter-vi/article-61/1: 1 sentence (may, shall) ·chapter-vi/article-62: 1 sentence (may) ·chapter-vi/article-64/1: 1 sentence (may) ·chapter-vi/article-65/1: 1 sentence (shall) ·chapter-vi/article-66/7: 1 sentence (may) ·chapter-vi/article-67/3: 1 sentence (shall) ·chapter-vii/section-1/article-78/1: 1 sentence (shall) ·chapter-vii/section-1/article-78/3: 1 sentence (shall) ·chapter-vii/section-1/article-81/1: 1 sentence (shall) ·chapter-vii/section-2/article-83/1: 1 sentence (shall, may) ·chapter-vii/section-2/article-84/1: 1 sentence (shall) ·chapter-vii/section-2/article-84/3: 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-85: 1 sentence (shall) ·chapter-vii/section-3/article-88/1: 1 sentence (shall) ·chapter-vii/section-3/article-88/5: 1 sentence (may) ·chapter-vii/section-3/article-89: 1 sentence (may, shall) ·chapter-vii/section-3/article-90/1: 1 sentence (shall) ·chapter-vii/section-3/article-90/5: 1 sentence (shall) ·chapter-vii/section-3/article-91/3: 1 sentence (may) ·chapter-vii/section-3/article-92/1: 1 sentence (shall) ·chapter-vii/section-3/article-93/1: 1 sentence (should, may) ·chapter-vii/section-3/article-94/2: 1 sentence (shall) ·chapter-vii/section-3/article-95/1: 1 sentence (shall) ·annex-i/chapter-i/3: 3 sentences (shall) ·annex-i/chapter-i/4: 2 sentences (shall) ·annex-i/chapter-ii: 10 sentences (shall) ·annex-i/chapter-iii: 1 sentence (shall) ·annex-ii/1.1: 1 sentence (may) ·annex-ii/5: 1 sentence (shall) ·annex-iii/1: 1 sentence (shall) ·annex-vi/part-a/2.1: 1 sentence (shall) ·annex-vi/part-b: 1 sentence (shall) ·annex-vii/1.4.2: 1 sentence (shall) ·annex-vii/3.2.5: 1 sentence (shall) ·annex-vii/3.2.6: 1 sentence (shall) ·annex-vii/4.5.1: 1 sentence (shall) ·annex-vii/4.5.3: 1 sentence (shall) ·annex-vii/4.5.4: 2 sentences (shall) ·annex-vii/4.8: 1 sentence (shall) ·annex-vii/4.10: 1 sentence (shall) ·annex-vii/4.11: 1 sentence (shall) ·annex-ix/chapter-i/2.2: 1 sentence (shall) ·annex-ix/chapter-i/3.2: 1 sentence (shall) ·annex-ix/chapter-ii: 2 sentences (shall) ·annex-xii/chapter-i/4: 1 sentence (shall) ·annex-xiii/part-a/1: 1 sentence (shall) ·annex-xiii/part-a/1.1: 1 sentence (shall) ·annex-xiii/part-b: 4 sentences (shall) ·annex-xiv/chapter-i/4.6: 1 sentence (shall) - EU Machinery Regulation
EU105 sentences; text first observedno clause anchor before this sentence: 14 sentences (should) ·chapter-i/article-3: 1 sentence (may) ·chapter-i/article-6/4: 1 sentence (shall) ·chapter-i/article-6/7: 2 sentences (shall) ·chapter-ii/article-10/9: 1 sentence (shall) ·chapter-ii/article-11/9: 1 sentence (shall) ·chapter-ii/article-13/2: 1 sentence (shall) ·chapter-ii/article-13/7: 1 sentence (shall) ·chapter-ii/article-14/2: 1 sentence (shall) ·chapter-ii/article-14/6: 1 sentence (shall) ·chapter-ii/article-15/3: 1 sentence (shall) ·chapter-ii/article-15/5: 1 sentence (shall) ·chapter-ii/article-16/3: 1 sentence (shall) ·chapter-ii/article-16/5: 1 sentence (shall) ·chapter-ii/article-18: 1 sentence (shall) ·chapter-iii/article-24/4: 1 sentence (may) ·chapter-vi/article-43/1: 2 sentences (shall) ·chapter-vi/article-43/4: 1 sentence (shall) ·chapter-vi/article-43/5: 1 sentence (shall) ·chapter-vi/article-45/1: 1 sentence (shall) ·chapter-vi/article-45/3: 2 sentences (shall) ·annex-iii/part-a: 1 sentence (may) ·annex-iii/part-b/1: 5 sentences (shall, may) ·annex-iii/part-b/4: 1 sentence (shall) ·annex-iii/part-b/5: 52 sentences (shall, may, should) ·annex-iii/part-b/6.1.1: 1 sentence (shall) ·annex-iii/part-b/6.2: 1 sentence (may) ·annex-iii/part-b/6.3.2: 2 sentences (shall, should) ·annex-iii/part-b/6.3.3: 1 sentence (shall) ·annex-iii/part-b/6.4.1: 1 sentence (shall) ·annex-iv/part-a: 1 sentence (shall) ·annex-iv/part-b: 1 sentence (shall) ·annex-x/2: 1 sentence (shall) - EU MDR
EU115 sentences; text first observedno clause anchor before this sentence: 13 sentences (should, may) ·chapter-i/article-1/2: 1 sentence (shall) ·chapter-i/article-2: 1 sentence (shall, may) ·chapter-ii/article-7: 1 sentence (shall, may) ·chapter-ii/article-8/1: 1 sentence (shall) ·chapter-ii/article-10/2: 1 sentence (shall) ·chapter-ii/article-10/9: 2 sentences (shall) ·chapter-ii/article-10/12: 1 sentence (shall) ·chapter-ii/article-10/16: 1 sentence (shall) ·chapter-ii/article-13/2: 1 sentence (shall) ·chapter-ii/article-13/7: 1 sentence (shall) ·chapter-ii/article-14/2: 1 sentence (shall) ·chapter-ii/article-14/4: 1 sentence (shall) ·chapter-ii/article-17/3: 1 sentence (may) ·chapter-ii/article-20/4: 1 sentence (may) ·chapter-iii/article-27/12: 1 sentence (shall) ·chapter-iv/article-45/2: 1 sentence (shall) ·chapter-iv/article-46/7: 1 sentence (shall) ·chapter-v/section-2/article-52/14: 1 sentence (may) ·chapter-v/section-2/article-54/2: 1 sentence (shall) ·chapter-vi/article-61/1: 1 sentence (shall) ·chapter-vi/article-61/10: 1 sentence (shall) ·chapter-vi/article-62/4: 1 sentence (may) ·chapter-vi/article-68/1: 1 sentence (may) ·chapter-vi/article-69/1: 1 sentence (shall) ·chapter-vi/article-71/3: 2 sentences (shall, may) ·chapter-vii/section-1/article-83/1: 1 sentence (shall) ·chapter-vii/section-1/article-83/3: 1 sentence (shall) ·chapter-vii/section-1/article-86/1: 1 sentence (shall) ·chapter-vii/section-2/article-88/1: 1 sentence (shall, may) ·chapter-vii/section-2/article-89/1: 1 sentence (shall) ·chapter-vii/section-2/article-89/3: 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-90: 1 sentence (shall) ·chapter-vii/section-3/article-93/1: 1 sentence (shall) ·chapter-vii/section-3/article-93/5: 1 sentence (may) ·chapter-vii/section-3/article-94: 1 sentence (may, shall) ·chapter-vii/section-3/article-95/1: 1 sentence (shall) ·chapter-vii/section-3/article-95/5: 1 sentence (shall) ·chapter-vii/section-3/article-96/3: 1 sentence (may) ·chapter-vii/section-3/article-97/1: 1 sentence (shall) ·chapter-vii/section-3/article-98/1: 1 sentence (should, may) ·chapter-vii/section-3/article-99/2: 1 sentence (shall) ·chapter-vii/section-3/article-100/1: 1 sentence (shall) ·annex-i/chapter-i/3: 3 sentences (shall) ·annex-i/chapter-i/4: 2 sentences (shall) ·annex-i/chapter-i/9: 1 sentence (shall) ·annex-i/chapter-ii: 13 sentences (shall) ·annex-i/chapter-iii: 2 sentences (shall, should) ·annex-ii/5: 1 sentence (shall) ·annex-iii: 1 sentence (shall) ·annex-vi/part-a/2.1: 1 sentence (may) ·annex-vi/part-b: 1 sentence (shall) ·annex-vii/1.4.2: 1 sentence (shall) ·annex-vii/3.2.5: 1 sentence (shall) ·annex-vii/3.2.6: 1 sentence (shall) ·annex-vii/4.5.1: 1 sentence (shall) ·annex-vii/4.5.3: 1 sentence (shall) ·annex-vii/4.5.4: 1 sentence (shall) ·annex-vii/4.5.5: 2 sentences (shall) ·annex-vii/4.8: 1 sentence (shall) ·annex-vii/4.10: 1 sentence (shall) ·annex-vii/4.11: 1 sentence (shall) ·annex-ix/chapter-i/2.2: 1 sentence (shall) ·annex-ix/chapter-i/3.2: 1 sentence (shall) ·annex-ix/chapter-ii: 11 sentences (shall, may) ·annex-xii/chapter-i/4: 1 sentence (shall) ·annex-xiv/part-a/1: 1 sentence (shall) ·annex-xiv/part-b: 3 sentences (shall) ·annex-xv/chapter-i/2.1: 1 sentence (shall) ·annex-xv/chapter-ii/4.6: 1 sentence (shall) - EU NIS2 Directive
EU67 sentences; text first observedno clause anchor before this sentence: 41 sentences (should, may) ·chapter-i/article-4/1: 1 sentence (shall) ·chapter-i/article-4/2: 1 sentence (shall) ·chapter-i/article-6: 1 sentence (may) ·chapter-ii/article-7/2: 1 sentence (shall) ·chapter-ii/article-11/3: 2 sentences (shall, may) ·chapter-iii/article-14/4: 1 sentence (shall) ·chapter-iii/article-18/1: 1 sentence (shall) ·chapter-iii/article-19/1: 1 sentence (shall) ·chapter-iii/article-19/8: 1 sentence (shall) ·chapter-iv/article-20/1: 1 sentence (shall) ·chapter-iv/article-20/2: 1 sentence (shall) ·chapter-iv/article-21/2: 1 sentence (shall) ·chapter-iv/article-21/3: 1 sentence (shall) ·chapter-iv/article-22/1: 1 sentence (may) ·chapter-iv/article-22/2: 1 sentence (shall, may) ·chapter-v/article-26/2: 1 sentence (shall) ·chapter-vii/article-31/2: 2 sentences (shall, may) ·chapter-vii/article-32/2: 2 sentences (shall) ·chapter-vii/article-32/4: 1 sentence (shall) ·chapter-vii/article-32/7: 1 sentence (shall) ·chapter-vii/article-33/2: 2 sentences (shall) ·chapter-vii/article-33/4: 1 sentence (shall) - FDA AI guidance
US22 sentences; text first observed7: 22 sentences (may, should) - FDA CSA
US1 sentence; text first observedno numbering read: 1 sentence (may) - FDA device cybersecurity (2026)
US65 sentences; text first observed6: 65 sentences (may, shall, should, must, is expected) - FDA electronic systems (clinical)
US11 sentences; text first observedno clause anchor before this sentence: 11 sentences (should, may, must) - FDA Part 11 scope
US1 sentence; text first observedno numbering read: 1 sentence (may) - FDA postmarket cybersecurity
US1 sentence; text first observedno numbering read: 1 sentence (may) - ICH Q12
International22 sentences; text first observed4: 22 sentences (should, must, may) - ICH Q13
International5 sentences; text first observedfollows a withheld heading: 5 sentences (may, should) - ICH Q14
International18 sentences; text first observed13.2: 17 sentences (may, should) · id repeats in this text: 1 sentence (may) - ICH Q2(R2)
International1 sentence; text first observedannex-2/3.3.2.2: 1 sentence (should) - ICH Q9(R1)
International38 sentences; text first observed8: 36 sentences (may, should) ·25: 2 sentences (should) - NIST AI 600-1
US11 sentences; text first observed3: 2 sentences (may) ·12: 9 sentences (may, should) - NIST AI RMF
International20 sentences; text first observedno clause anchor before this sentence: 1 sentence (may) ·1.2.1: 2 sentences (may) ·1.2.2: 4 sentences (may, should) ·1.2.3: 1 sentence (may) ·1.2.4: 2 sentences (should, may) ·3.2: 2 sentences (may, should) ·3.5: 1 sentence (may) ·5: 1 sentence (should) ·5.1: 1 sentence (should) ·5.2: 1 sentence (may) ·6: 4 sentences (may, should) - NISTIR 8183
US4 sentences; text first observed7: 4 sentences (may, should)
In titles
5 tracked rows whose titles print one of the forms in the heading, read from the title this record holds, by the same exact rule.
- ICH Q9(R1) — Quality Risk Management
International - ISO 14971 — Application of risk management to medical devices
International - ISO/IEC 23894 — AI guidance on risk management
International - ISPE GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition)
International - NIST AI Risk Management Framework 1.0
International
In body
1098 occurrences in 49 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.
- EMA CT computerised systems
EU16 occurrences; text first observed16 where the heading before it is withheld - Annex 15 revision concept paper
International5 occurrences; text first observed2: 2 ·6: 3 - DI revision concept paper
International1 occurrence; text first observed1 where no numbering read in this text - EU AI Act
EU82 occurrences; text first observedannex-iii: 2 ·annex-iii/5: 1 ·annex-iii/6: 2 ·annex-iii/7: 4 ·annex-iv/5: 1 ·annex-viii/13: 2 ·annex-xi/section-2: 1 ·chapter-i/article-1/2: 1 ·chapter-i/article-2/12: 1 ·chapter-i/article-2/2: 2 ·chapter-iii/section-1: 1 ·chapter-iii/section-1/article-6: 1 ·chapter-iii/section-1/article-6/6: 1 ·chapter-iii/section-1/article-7/1: 5 ·chapter-iii/section-1/article-7/3: 2 ·chapter-iii/section-2: 1 ·chapter-iii/section-2/article-10/6: 1 ·chapter-iii/section-2/article-9: 1 ·chapter-iii/section-3: 1 ·chapter-iii/section-3/article-22: 1 ·chapter-iii/section-3/article-26: 1 ·chapter-iii/section-3/article-27: 1 ·chapter-iii/section-3/article-27/2: 1 ·chapter-iii/section-5/article-43/6: 1 ·chapter-ix/section-1/article-72: 1 ·chapter-ix/section-3/article-79: 1 ·chapter-ix/section-3/article-80: 1 ·chapter-ix/section-3/article-82: 1 ·chapter-v/section-1/article-51: 1 ·chapter-v/section-3: 1 ·chapter-v/section-3/article-55: 1 ·chapter-vi/article-60: 1 ·chapter-viii/article-71: 1 · 37 where no heading is read before it - EU Cyber Resilience Act
EU16 occurrences; text first observedchapter-i/article-12: 1 ·chapter-i/article-7/2: 1 ·chapter-ii/article-16/2: 1 ·chapter-v/article-54: 1 ·chapter-v/article-56: 1 ·chapter-v/article-57: 1 · 10 where no heading is read before it - EU Cybersecurity Act
EU3 occurrences; text first observed3 where no heading is read before it - Regulation (EU) 2026/1744
EU35 occurrences; text first observedarticle-1/5: 2 · 33 where no heading is read before it - EU GMP Annex 1
EU14 occurrences; text first observedannex-1/11: 14 - EU GMP Annex 11
EU1 occurrence; text first observed1 where no heading is read before it - EU GMP Annex 11 (draft)
EU8 occurrences; text first observed17: 7 ·4: 1 - EU GMP Annex 13
EU2 occurrences; text first observed2 where no heading is read before it - EU GMP Annex 14
EU2 occurrences; text first observed10: 1 · 1 where no heading is read before it - EU GMP Annex 15
EU3 occurrences; text first observed12: 3 - EU GMP Annex 17
EU1 occurrence; text first observed1 where no heading is read before it - EU GMP Annex 19
EU1 occurrence; text first observed9.1: 1 - EU GMP Annex 2
EU3 occurrences; text first observed36: 2 ·5: 1 - EU GMP Annex 3
EU1 occurrence; text first observed1: 1 - EU GMP Chapter 1
EU8 occurrences; text first observedchapter-1: 8 - EU GMP Chapter 2
EU1 occurrence; text first observed1 where no heading is read before it - EU GMP Chapter 3
EU1 occurrence; text first observedpart-1: 1 - EU GMP Chapter 4
EU1 occurrence; text first observed1 where no numbering read in this text - EU GMP Chapter 4 (draft)
EU11 occurrences; text first observed11 where no numbering read in this text - EU GMP Chapter 5
EU6 occurrences; text first observedpart-1: 6 - EU GMP Chapter 8
EU2 occurrences; text first observedpart-1: 2 - EU IVDR
EU17 occurrences; text first observedannex-i/chapter-i/2: 1 ·annex-iv/5: 1 ·annex-viii/2.1: 1 ·annex-viii/2.3: 5 ·annex-xiv/chapter-i/2.1: 1 ·annex-xiv/chapter-i/2.5: 2 ·annex-xiv/chapter-i/2.6: 1 ·chapter-i/section-1/article-2: 2 ·chapter-vi/article-67/3: 2 ·chapter-vii/section-3/article-90: 1 - EU Machinery Regulation
EU8 occurrences; text first observedannex-iii/part-b/5: 2 ·annex-iii/part-b/6.1.2: 1 ·chapter-vi/article-43: 1 ·chapter-vi/article-45: 1 · 3 where no heading is read before it - EU MDR
EU9 occurrences; text first observedannex-i/chapter-i/2: 1 ·annex-ii/1.1: 1 ·annex-iv/5: 1 ·annex-xv/chapter-ii/2.1: 1 ·annex-xv/chapter-ii/2.5: 2 ·annex-xv/chapter-ii/2.6: 1 ·chapter-vii/section-3/article-95: 1 · 1 where no heading is read before it - EU NIS2 Directive
EU13 occurrences; text first observedchapter-i/article-1/2: 1 ·chapter-i/article-2/2: 2 ·chapter-iv/article-21: 1 ·chapter-iv/article-22: 1 · 8 where no heading is read before it - FDA AI guidance
US39 occurrences; text first observed3: 1 ·7: 37 · 1 where no heading is read before it - FDA AI device list
US1 occurrence; text first observed1 where no numbering read in this text - FDA CDRH AI/ML
US1 occurrence; text first observed1 where no numbering read in this text - FDA device cybersecurity
US1 occurrence; text first observed1 where no numbering read in this text - FDA device cybersecurity (2026)
US89 occurrences; text first observed1: 1 ·2: 1 ·6: 87 - FDA electronic systems (clinical)
US8 occurrences; text first observed12: 1 · 7 where no heading is read before it - FDA/EMA AI principles
International7 occurrences; text first observed7 where no numbering read in this text - FDA Part 11 scope
US7 occurrences; text first observed7 where no numbering read in this text - FDA postmarket cybersecurity
US1 occurrence; text first observed1 where no numbering read in this text - Health Canada ML
Canada7 occurrences; text first observed7 where no numbering read in this text - ICH Q12
International27 occurrences; text first observed4: 27 - ICH Q13
International18 occurrences; text first observed18 where the heading before it is withheld - ICH Q14
International59 occurrences; text first observed13.2: 51 ·4: 1 ·4.2: 1 · 6 where the heading before it is withheld - ICH Q2(R2)
International2 occurrences; text first observedannex-2/1.2: 1 ·annex-2/2.2: 1 - ICH Q9(R1)
International291 occurrences; text first observed10: 1 ·19: 1 ·21: 1 ·25: 59 ·3: 1 ·4: 1 ·4.2: 1 ·4.3: 1 ·4.4: 1 ·4.5: 1 ·4.6: 1 ·5: 1 ·5.1: 1 ·5.2: 1 ·6: 1 ·6.1: 1 ·8: 215 · 2 where no heading is read before it - NIST AI 600-1
US94 occurrences; text first observed12: 76 ·3: 15 ·9: 1 · 2 where no heading is read before it - NIST AI RMF
International85 occurrences; text first observed1: 2 ·1.1: 3 ·1.2.1: 10 ·1.2.2: 9 ·1.2.3: 7 ·1.2.4: 1 ·10: 1 ·2: 1 ·3.3: 1 ·3.5: 1 ·3.7: 1 ·4: 1 ·5.1: 10 ·5.2: 6 ·5.3: 6 ·5.4: 6 ·6: 13 · 6 where no heading is read before it - NIST AI RMF Playbook
US1 occurrence; text first observed1 where no numbering read in this text - NIST CSF 2.0
US5 occurrences; text first observed5 where no numbering read in this text - NIST SP 800-82
US2 occurrences; text first observed2 where no numbering read in this text - NISTIR 8183
US82 occurrences; text first observed6: 1 ·6.3: 1 ·7: 76 · 4 where no heading is read before it
Co-occurrence
281 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. 577 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 1 clause:
eu-machinery-regulationchapter-i/article-3 - Act 4 clauses:
eu-digital-omnibus-aiarticle-3;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124 - active device 1 clause:
eu-mdrchapter-i/article-2 - actively exploited vulnerability 2 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-14/8 - adverse event 6 clauses:
eu-gmp-annex-1410;eu-gmp-annex-236;eu-gmp-chapter-8part-1;eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2;nist-ai-rmf3.3 - Agency 5 clauses:
eu-gmp-annex-1410;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 14 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-25/4·chapter-ix/section-3/article-74/11·chapter-ix/section-3/article-75/2·chapter-ix/section-3/article-75/3·chapter-ix/section-5/article-90/1·chapter-ix/section-5/article-92/1·chapter-v/section-3/article-55/1·chapter-vii/section-1/article-68/3·chapter-x/article-95/1·chapter-xiii/article-112/11;eu-digital-omnibus-aiarticle-1/5·article-1/6·article-1/9 - AI regulatory sandbox 2 clauses:
eu-ai-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/6 - AI system 117 clauses:
eu-ai-actannex-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-12/2·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-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-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-ix/section-1/article-72/1·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;eu-digital-omnibus-aiarticle-1·article-1/3·article-1/4·article-1/5·article-1/6;nist-ai-600-112·3·9;nist-ai-rmf1.2.1·1.2.3·1.2.4·3.3·3.5·3.7·4·5·5.1·5.2·5.3·5.4·6 - allow-list 1 clause:
fda-device-cybersecurity-20266 - analytical performance 6 clauses:
eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii·annex-xiii/part-a/1·chapter-i/section-1/article-2·chapter-vi/article-58/5·chapter-vi/article-67/3 - Application 9 clauses:
eu-digital-omnibus-aiarticle-1/9;eu-machinery-regulationannex-iii/part-b/5;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;ich-q9r110;nist-ai-rmf2·6;nistir-81837 - assurance level 6 clauses:
eu-cyber-resilience-actchapter-i/article-8/1;eu-cybersecurity-acttitle-iii/article-52/1·title-iii/article-52/6·title-iii/article-52/7·title-iii/article-53/1;eu-gmp-annex-1annex-1/11 - Audits 1 clause:
eu-gmp-chapter-5part-1 - authorised representative 37 clauses:
eu-ai-actannex-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-22/1·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-actchapter-i/article-3;eu-ivdrannex-i/chapter-iii·annex-ix/chapter-i/2.2·annex-vi/part-b·chapter-i/section-1/article-2·chapter-ii/article-10/11·chapter-ii/article-13/2·chapter-ii/article-13/7·chapter-ii/article-14/2·chapter-ii/article-14/4·chapter-vii/section-2/article-85·chapter-vii/section-3/article-90/1;eu-machinery-regulationannex-iii/part-b/5·annex-x/2·chapter-i/article-3;eu-mdrannex-i/chapter-iii·annex-ix/chapter-i/2.2·annex-vi/part-b·chapter-i/article-2·chapter-ii/article-10/12·chapter-ii/article-13/2·chapter-ii/article-13/7·chapter-ii/article-14/2·chapter-ii/article-14/4·chapter-vii/section-2/article-90·chapter-vii/section-3/article-95/1 - Autonomous mobile machinery 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - benefit-risk determination 10 clauses:
eu-ivdrannex-ix/chapter-ii·chapter-i/section-1/article-2·chapter-vii/section-1/article-78/3·chapter-vii/section-1/article-81/1·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-1/article-86/1·chapter-vii/section-2/article-90 - biometric categorisation system 1 clause:
eu-ai-actchapter-i/article-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 4 clauses:
eu-ai-actchapter-i/article-3·chapter-ii/article-5/1·chapter-iii/section-3/article-26/10;eu-digital-omnibus-aiarticle-1/9 - biometric verification 1 clause:
eu-ai-actchapter-i/article-3 - 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·chapter-iii/article-30/3;eu-ivdrannex-xiii/part-b·chapter-i/section-1/article-2·chapter-ii/article-18/4;eu-machinery-regulationchapter-i/article-3·chapter-ii/article-13/2·chapter-iii/article-24/4;eu-mdrannex-xiv/part-b·chapter-i/article-2·chapter-ii/article-20/4 - CE marking of conformity 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - chains 14 clauses:
eu-cyber-resilience-actchapter-v/article-54/2·chapter-v/article-56/2;eu-gmp-annex-236;eu-machinery-regulationannex-iii/part-b/5·annex-iii/part-b/6.1.1·chapter-i/article-3;eu-nis2chapter-iii/article-14/4·chapter-iv/article-21/3·chapter-iv/article-22·chapter-iv/article-22/1;ich-q124;ich-q9r125·8;nist-ai-600-112 - clinical benefit 7 clauses:
eu-ivdrchapter-i/section-1/article-2·chapter-vii/section-2/article-84/3;eu-mdrannex-i/chapter-ii·annex-i/chapter-iii·annex-xv/chapter-ii/2.6·chapter-i/article-2·chapter-vii/section-2/article-89/3 - clinical data 13 clauses:
eu-ivdrannex-vii/4.10·annex-vii/4.11·chapter-i/section-1/article-2;eu-mdrannex-ix/chapter-ii·annex-vii/4.10·annex-vii/4.11·annex-vii/4.5.4·annex-vii/4.5.5·annex-xiv/part-a/1·annex-xiv/part-b·chapter-i/article-2·chapter-vi/article-61/1·chapter-vi/article-61/10 - clinical evaluation 23 clauses:
eu-ivdrannex-ix/chapter-i/2.2;eu-mdrannex-ix/chapter-i/2.2·annex-ix/chapter-ii·annex-vii/3.2.5·annex-vii/4.10·annex-vii/4.11·annex-vii/4.5.1·annex-vii/4.5.3·annex-vii/4.5.4·annex-vii/4.5.5·annex-vii/4.8·annex-xiv/part-a/1·annex-xiv/part-b·chapter-i/article-1/2·chapter-i/article-2·chapter-ii/article-10/9·chapter-ii/article-8/1·chapter-v/section-2/article-54/2·chapter-vi/article-61/1·chapter-vi/article-61/10·chapter-vi/article-62/4·chapter-vi/article-71/3·chapter-vii/section-1/article-83/3 - clinical evidence 12 clauses:
eu-ivdrannex-ix/chapter-ii·annex-vii/4.5.4·annex-xiii/part-a/1·annex-xiii/part-b·chapter-i/section-1/article-2·chapter-ii/article-8/1·chapter-vi/article-56/1;eu-mdrannex-ix/chapter-ii·annex-vii/4.5.5·annex-xiv/part-a/1·chapter-i/article-2·chapter-vi/article-61/1 - clinical investigation 9 clauses:
eu-mdrannex-i/chapter-iii·annex-vi/part-a/2.1·annex-vii/4.5.5·chapter-i/article-2·chapter-vi/article-62/4·chapter-vi/article-68/1·chapter-vi/article-69/1·chapter-vi/article-71/3;fda-ai-guidance7 - clinical investigation plan 4 clauses:
eu-mdrannex-vii/4.5.5·chapter-i/article-2·chapter-vi/article-62/4·chapter-vi/article-68/1 - clinical performance 16 clauses:
eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii·annex-xiii/part-a/1·annex-xiii/part-a/1.1·annex-xiii/part-b·chapter-i/section-1/article-2·chapter-vi/article-56/1·chapter-vi/article-58/5·chapter-vi/article-64/1·chapter-vi/article-67/3;eu-mdrannex-i/chapter-iii·annex-vi/part-a/2.1·annex-xiv/part-a/1·chapter-i/article-2·chapter-vi/article-61/10·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 4 clauses:
eu-ivdrannex-i/chapter-iii·annex-ii/1.1·annex-ix/chapter-ii·chapter-i/section-1/article-2 - Component / component 18 clauses:
eu-ai-actchapter-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·article-3;eu-gmp-annex-1annex-1/11;eu-gmp-annex-1410;eu-gmp-annex-236;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 63 clauses:
eu-ai-actchapter-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-4/article-31/5·chapter-iii/section-4/article-34/1·chapter-iii/section-4/article-36/3·chapter-iii/section-4/article-38/1·chapter-iii/section-5/article-43/1·chapter-iii/section-5/article-43/2·chapter-iii/section-5/article-43/3·chapter-iii/section-5/article-43/4·chapter-iii/section-5/article-43/6·chapter-iii/section-5/article-46/1·chapter-iii/section-5/article-46/7·chapter-iii/section-5/article-48/4;eu-cyber-resilience-actchapter-i/article-12/2·chapter-i/article-12/3·chapter-i/article-3·chapter-i/article-7/3·chapter-i/article-8/1;eu-digital-omnibus-aiarticle-1/3·article-1/5·article-1/6·article-1/9;eu-ivdrannex-ix/chapter-i/2.2·annex-ix/chapter-ii·annex-vii/3.2.5·annex-vii/3.2.6·annex-vii/4.5.1·annex-vii/4.5.3·annex-vii/4.5.4·annex-xii/chapter-i/4·annex-xiii/part-b·chapter-i/section-1/article-2·chapter-ii/article-10/8·chapter-ii/article-7·chapter-v/section-2/article-48/13;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3·chapter-ii/article-13/2·chapter-ii/article-18;eu-mdrannex-i/chapter-ii·annex-ix/chapter-i/2.2·annex-ix/chapter-ii·annex-vii/3.2.5·annex-vii/3.2.6·annex-vii/4.5.1·annex-vii/4.5.3·annex-vii/4.5.5·annex-xii/chapter-i/4·annex-xiv/part-b·chapter-i/article-2·chapter-ii/article-10/9·chapter-ii/article-7·chapter-v/section-2/article-52/14;nist-ai-600-112 - conformity assessment body 8 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-4/article-31/4·chapter-iii/section-4/article-31/5;eu-cyber-resilience-actchapter-i/article-3;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-iii/article-53/1 - consumer 3 clauses:
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 33 clauses:
eu-ai-actchapter-iii/section-3/article-20/2·chapter-ix/section-2/article-73/6·chapter-ix/section-3/article-80/2;eu-gmp-annex-1annex-1/11;eu-ivdrannex-vii/4.10·chapter-i/section-1/article-2·chapter-ii/article-10/11·chapter-ii/article-13/7·chapter-ii/article-14/4·chapter-vii/section-1/article-78/3·chapter-vii/section-2/article-84/1·chapter-vii/section-2/article-84/3·chapter-vii/section-2/article-84/7·chapter-vii/section-2/article-84/8·chapter-vii/section-3/article-90/1;eu-machinery-regulationchapter-vi/article-43/1·chapter-vi/article-43/4;eu-mdrannex-vi/part-a/2.1·annex-vi/part-b·annex-vii/4.10·chapter-i/article-2·chapter-ii/article-10/12·chapter-ii/article-13/7·chapter-ii/article-14/4·chapter-vii/section-1/article-83/3·chapter-vii/section-2/article-89/1·chapter-vii/section-2/article-89/3·chapter-vii/section-2/article-89/7·chapter-vii/section-2/article-89/8·chapter-vii/section-3/article-95/1;fda-device-cybersecurity-20266;ich-q124;ich-q9r125 - critical infrastructure 3 clauses:
eu-ai-actchapter-i/article-3;nist-ai-600-112;nistir-81837 - CSIRT designated as coordinator 3 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-15/1·chapter-ii/article-16/2 - custom-made device 2 clauses:
eu-mdrannex-i/chapter-iii·chapter-i/article-2 - cyber threat 7 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-cybersecurity-acttitle-iii/article-47/3;eu-nis2chapter-i/article-6·chapter-iii/article-18/1·chapter-vii/article-32/4·chapter-vii/article-33/4;fda-device-cybersecurity-20266 - cybersecurity 67 clauses:
eu-ai-actchapter-iii/section-2/article-13/3·chapter-iii/section-2/article-15/1·chapter-iii/section-2/article-15/5·chapter-iii/section-5/article-42/2·chapter-ix/section-3/article-78/2·chapter-v/section-3/article-55/1;eu-cyber-resilience-actannex-i/part-i·chapter-i/article-12/1·chapter-i/article-12/2·chapter-i/article-12/3·chapter-i/article-3·chapter-i/article-7/2·chapter-i/article-7/3·chapter-i/article-8/1·chapter-ii/article-13/3·chapter-ii/article-13/4·chapter-ii/article-13/7·chapter-ii/article-16/2·chapter-ii/article-19/3·chapter-ii/article-19/5·chapter-ii/article-20/3·chapter-ii/article-20/4·chapter-iii/article-30/3·chapter-iv/article-47/2·chapter-v/article-54·chapter-v/article-54/1·chapter-v/article-54/2·chapter-v/article-54/6·chapter-v/article-56·chapter-v/article-56/1·chapter-v/article-56/2·chapter-v/article-57·chapter-v/article-57/1;eu-cybersecurity-acttitle-ii/chapter-ii/article-11·title-ii/chapter-ii/article-5·title-iii/article-47/3·title-iii/article-52/1·title-iii/article-52/4·title-iii/article-52/6·title-iii/article-52/7·title-iii/article-53/1;eu-digital-omnibus-aiarticle-1/5;eu-nis2chapter-i/article-1/2·chapter-i/article-4/1·chapter-i/article-4/2·chapter-i/article-6·chapter-ii/article-11/3·chapter-ii/article-7/2·chapter-iii/article-14/4·chapter-iii/article-18/1·chapter-iii/article-19/1·chapter-iii/article-19/8·chapter-iv/article-20/1·chapter-iv/article-20/2·chapter-iv/article-21/2·chapter-iv/article-21/3·chapter-v/article-26/2·chapter-vii/article-32/2·chapter-vii/article-32/4·chapter-vii/article-32/7·chapter-vii/article-33/2·chapter-vii/article-33/4;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-600-112;nist-ai-rmf6;nistir-81837 - cybersecurity risk 43 clauses:
eu-cyber-resilience-actannex-i/part-i·chapter-i/article-3·chapter-i/article-7/3·chapter-i/article-8/1·chapter-ii/article-13/3·chapter-ii/article-13/4·chapter-ii/article-13/7·chapter-ii/article-16/2·chapter-ii/article-19/3·chapter-ii/article-19/5·chapter-ii/article-20/3·chapter-ii/article-20/4·chapter-iii/article-30/3·chapter-iv/article-47/2·chapter-v/article-54·chapter-v/article-54/1·chapter-v/article-54/2·chapter-v/article-56·chapter-v/article-56/1·chapter-v/article-56/2·chapter-v/article-57·chapter-v/article-57/1;eu-nis2chapter-i/article-1/2·chapter-i/article-4/1·chapter-i/article-4/2·chapter-i/article-6·chapter-ii/article-7/2·chapter-iii/article-18/1·chapter-iii/article-19/1·chapter-iv/article-20/1·chapter-iv/article-20/2·chapter-iv/article-21/2·chapter-v/article-26/2·chapter-vii/article-32/2·chapter-vii/article-32/4·chapter-vii/article-32/7·chapter-vii/article-33/2·chapter-vii/article-33/4;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-600-112;nist-ai-rmf6;nistir-81837 - danger zone 2 clauses:
eu-machinery-regulationannex-iii/part-a·annex-iii/part-b/5 - data centre service 1 clause:
eu-nis2chapter-i/article-6 - deep fake 1 clause:
eu-ai-actchapter-i/article-3 - deployer 23 clauses:
eu-ai-actannex-viii/13·chapter-i/article-3·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-ix/section-2/article-73/4·chapter-ix/section-3/article-78/3·chapter-ix/section-4/article-86/1·chapter-vi/article-60/4;eu-digital-omnibus-aiarticle-1/3·article-1/4·article-1/6·article-1/9 - derivative 4 clauses:
eu-mdrannex-i/chapter-iii·annex-ix/chapter-ii·annex-xv/chapter-ii/2.6·chapter-i/article-2 - device deficiency 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - device for near-patient testing 1 clause:
eu-ivdrchapter-i/section-1/article-2 - device for performance study 3 clauses:
eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2·chapter-vi/article-67/3 - device for self-testing 1 clause:
eu-ivdrchapter-i/section-1/article-2 - device software function 1 clause:
fda-device-cybersecurity-20266 - diagnostic sensitivity 3 clauses:
eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii·chapter-i/section-1/article-2 - diagnostic specificity 3 clauses:
eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii·chapter-i/section-1/article-2 - digital service 1 clause:
eu-nis2chapter-i/article-6 - distributor 17 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·chapter-ii/article-20/3;eu-ivdrchapter-i/section-1/article-2·chapter-ii/article-14/2·chapter-ii/article-14/4;eu-machinery-regulationchapter-i/article-3·chapter-ii/article-15/3·chapter-ii/article-16/3;eu-mdrchapter-i/article-2·chapter-ii/article-14/2·chapter-ii/article-14/4 - 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 19 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-v/article-54/1·chapter-v/article-54/6·chapter-v/article-57/1;eu-ivdrchapter-i/section-1/article-2·chapter-vii/section-3/article-90/1·chapter-vii/section-3/article-90/5·chapter-vii/section-3/article-92/1·chapter-vii/section-3/article-94/2;eu-machinery-regulationchapter-i/article-3·chapter-vi/article-43/1·chapter-vi/article-43/4·chapter-vi/article-43/5·chapter-vi/article-45/1;eu-mdrchapter-i/article-2·chapter-vii/section-3/article-95/1·chapter-vii/section-3/article-95/5·chapter-vii/section-3/article-97/1·chapter-vii/section-3/article-99/2 - 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 - emotion recognition system 1 clause:
eu-ai-actchapter-i/article-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 17 clauses:
eu-ai-actchapter-i/article-3;eu-gmp-annex-236;eu-gmp-chapter-5part-1;eu-ivdrchapter-vi/article-58/5;eu-mdrchapter-vi/article-62/4;eu-nis2chapter-i/article-2/2·chapter-i/article-6·chapter-ii/article-11/3·chapter-iv/article-20/2·chapter-iv/article-21/2·chapter-v/article-26/2·chapter-vii/article-32/2·chapter-vii/article-32/7·chapter-vii/article-33/2;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 16 clauses:
eu-digital-omnibus-aiarticle-3;eu-machinery-regulationannex-iii/part-b/1·annex-iii/part-b/4·annex-iii/part-b/5·annex-iv/part-a·annex-iv/part-b·annex-x/2·chapter-i/article-3·chapter-i/article-6/7·chapter-ii/article-11/9·chapter-ii/article-14/2·chapter-ii/article-14/6·chapter-ii/article-16/3·chapter-ii/article-16/5·chapter-vi/article-43/5·chapter-vi/article-45/1 - ethics committee 5 clauses:
eu-ivdrchapter-i/section-1/article-2·chapter-vi/article-58/5·chapter-vi/article-66/7;eu-mdrchapter-i/article-2·chapter-vi/article-62/4 - European cybersecurity certificate 4 clauses:
eu-cyber-resilience-actchapter-i/article-12/3·chapter-i/article-8/1;eu-cybersecurity-acttitle-iii/article-52/6·title-iii/article-52/7 - European cybersecurity certification scheme 3 clauses:
eu-cyber-resilience-actchapter-i/article-8/1;eu-cybersecurity-acttitle-iii/article-52/1·title-iii/article-53/1 - 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 - exposed person 1 clause:
eu-machinery-regulationannex-iii/part-a - falsified device 6 clauses:
eu-ivdrchapter-i/section-1/article-2·chapter-ii/article-13/2·chapter-ii/article-14/2;eu-mdrchapter-i/article-2·chapter-ii/article-13/2·chapter-ii/article-14/2 - Federal Food, Drug, and Cosmetic Act 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - field safety corrective action 12 clauses:
eu-ivdrchapter-i/section-1/article-2·chapter-vii/section-1/article-78/3·chapter-vii/section-2/article-84/1·chapter-vii/section-2/article-84/3·chapter-vii/section-2/article-84/8;eu-mdrannex-vi/part-a/2.1·annex-vi/part-b·chapter-i/article-2·chapter-vii/section-1/article-83/3·chapter-vii/section-2/article-89/1·chapter-vii/section-2/article-89/3·chapter-vii/section-2/article-89/8 - 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 14 clauses:
eu-ai-actannex-xiii·chapter-i/article-3·chapter-ix/section-3/article-75/3·chapter-ix/section-5/article-90/1·chapter-ix/section-5/article-90/3·chapter-ix/section-5/article-92/1·chapter-ix/section-5/article-93/3·chapter-v/section-1/article-51/1·chapter-v/section-1/article-52/1·chapter-v/section-1/article-52/2·chapter-v/section-1/article-52/3·chapter-v/section-1/article-52/5·chapter-v/section-3/article-55/1·chapter-xii/article-101/1 - 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 4 clauses:
eu-gmp-chapter-8part-1;eu-machinery-regulationannex-iii/part-a·annex-iii/part-b/5·chapter-i/article-3 - Guided load 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - hardware 15 clauses:
ema-annex11-concept-paper1;eu-ai-actchapter-iii/section-2/article-13/3;eu-cyber-resilience-actchapter-i/article-3;eu-gmp-annex-11-draft17;eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-i/chapter-ii·annex-i/chapter-iii;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 8 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-5/article-43/1·chapter-v/section-3/article-55/2;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrchapter-i/article-2 - Hazard / hazard 13 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-ivdrannex-i/chapter-i/4·annex-i/chapter-iii;eu-machinery-regulationannex-iii/part-a·annex-iii/part-b/5·chapter-i/article-3·chapter-i/article-6/4;eu-mdrannex-i/chapter-i/4;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 2 clauses:
eu-ai-actannex-xiii·chapter-i/article-3 - ICT process 2 clauses:
eu-cybersecurity-acttitle-iii/article-52/1;eu-nis2chapter-i/article-6 - ICT product 2 clauses:
eu-cybersecurity-acttitle-iii/article-52/1;eu-nis2chapter-i/article-6 - ICT service 2 clauses:
eu-cybersecurity-acttitle-iii/article-52/1;eu-nis2chapter-i/article-6 - identity management 1 clause:
fda-device-cybersecurity-20266 - implantable device 1 clause:
eu-mdrchapter-i/article-2 - importer 23 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·chapter-ii/article-19/3;eu-gmp-chapter-5part-1;eu-ivdrchapter-i/section-1/article-2·chapter-ii/article-13/2·chapter-ii/article-14/2·chapter-ii/article-14/4;eu-machinery-regulationchapter-i/article-3·chapter-ii/article-13/2·chapter-ii/article-14/2·chapter-ii/article-15/3·chapter-ii/article-16/3;eu-mdrchapter-i/article-2·chapter-ii/article-13/2·chapter-ii/article-14/2·chapter-ii/article-14/4 - in vitro diagnostic medical device 2 clauses:
eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2 - incident 36 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-73/1·chapter-ix/section-2/article-73/10·chapter-ix/section-2/article-73/4·chapter-ix/section-2/article-73/6;eu-cyber-resilience-actannex-i/part-i·chapter-i/article-3·chapter-ii/article-14/8;eu-cybersecurity-acttitle-ii/chapter-ii/article-5·title-iii/article-52/1;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-236;eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2·chapter-vii/section-2/article-84/1·chapter-vii/section-2/article-84/3·chapter-vii/section-2/article-84/7;eu-mdrannex-i/chapter-iii·chapter-i/article-2·chapter-vii/section-2/article-89/1·chapter-vii/section-2/article-89/3·chapter-vii/section-2/article-89/7;eu-nis2chapter-i/article-1/2·chapter-i/article-4/2·chapter-i/article-6·chapter-ii/article-11/3·chapter-iv/article-21/2·chapter-vii/article-32/2·chapter-vii/article-32/4;fda-device-cybersecurity-20266;nist-ai-600-112;nist-ai-rmf5.2;nistir-81837 - incident handling 3 clauses:
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 12 clauses:
eu-ai-actchapter-i/article-3·chapter-vi/article-60/4;eu-ivdrchapter-i/section-1/article-2·chapter-vi/article-58/5·chapter-vi/article-60/1·chapter-vi/article-61/1·chapter-vi/article-64/1;eu-mdrchapter-i/article-2·chapter-vi/article-62/4·chapter-vi/article-68/1;fda-device-cybersecurity-20266;nist-ai-600-112 - input data 7 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-2/article-12/3·chapter-iii/section-2/article-13/3·chapter-iii/section-3/article-26/4;ich-q1413.2;nist-ai-600-112·3 - instructions for use 36 clauses:
eu-ai-actannex-viii/12·chapter-i/article-3·chapter-iii/section-2/article-13/2·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-26/1·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-i/chapter-iii·annex-ix/chapter-ii·annex-vi/part-b·annex-vii/4.10·annex-xii/chapter-i/4·chapter-i/section-1/article-2·chapter-ii/article-13/2·chapter-ii/article-7·chapter-vii/section-1/article-78/3;eu-machinery-regulationannex-iii/part-a·annex-iii/part-b/5·annex-iv/part-a·chapter-i/article-3;eu-mdrannex-i/chapter-ii·annex-i/chapter-iii·annex-ix/chapter-ii·annex-vi/part-b·annex-vii/4.10·annex-xii/chapter-i/4·chapter-i/article-2·chapter-ii/article-13/2·chapter-ii/article-7·chapter-vii/section-1/article-83/3 - intended purpose 56 clauses:
eu-ai-actannex-viii/13·chapter-i/article-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-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-9/6·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-i/part-i·chapter-i/article-3·chapter-i/article-8/1·chapter-ii/article-13/3;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-i/chapter-iii·annex-ii/1.1·annex-ix/chapter-ii·annex-xii/chapter-i/4·annex-xiii/part-a/1·annex-xiii/part-a/1.1·annex-xiii/part-b·annex-xiv/chapter-i/2.1·chapter-i/section-1/article-2·chapter-ii/article-7·chapter-vi/article-56/1·chapter-vi/article-58/5;eu-machinery-regulationchapter-i/article-3;eu-mdrannex-i/chapter-ii·annex-i/chapter-iii·annex-ii/1.1·annex-ix/chapter-ii·annex-vi/part-a/2.1·annex-xii/chapter-i/4·annex-xiv/part-a/1·annex-xiv/part-b·annex-xv/chapter-ii/2.1·chapter-i/article-2·chapter-ii/article-7·chapter-v/section-2/article-54/2·chapter-vi/article-61/1;ich-q1413.2;nist-ai-600-112 - intended use 28 clauses:
eu-cybersecurity-acttitle-iii/article-52/1;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/4.5.4·annex-xiii/part-a/1.1·chapter-vi/article-56/1;eu-machinery-regulationannex-iii/part-a·annex-iii/part-b/1·annex-iii/part-b/5·annex-iv/part-a·chapter-i/article-6/4;eu-mdrannex-i/chapter-i/3·annex-i/chapter-ii·annex-vii/4.5.5·chapter-vi/article-61/1;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r125·8;nist-ai-600-112;nist-ai-rmf5.2 - 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 1 clause:
eu-mdrchapter-i/article-2 - investigational device 3 clauses:
eu-mdrchapter-i/article-2·chapter-vi/article-62/4·chapter-vi/article-71/3 - investigator 6 clauses:
eu-ivdrchapter-i/section-1/article-2·chapter-vi/article-60/1·chapter-vi/article-61/1·chapter-vi/article-64/1;eu-mdrchapter-i/article-2·chapter-vi/article-68/1 - kit 2 clauses:
eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2 - label 15 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-chapter-5part-1;eu-gmp-chapter-6part-1;eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii·annex-ix/chapter-ii·annex-vi/part-b·chapter-i/section-1/article-2;eu-mdrannex-i/chapter-ii·annex-i/chapter-iii·annex-vi/part-b·annex-xiv/part-b·chapter-i/article-2;ich-q9r125;nist-ai-600-112 - large-scale cybersecurity incident 1 clause:
eu-nis2chapter-i/article-6 - law enforcement 14 clauses:
eu-ai-actannex-iii/6·annex-viii/12·chapter-i/article-3·chapter-ii/article-5/1·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-iii/section-5/article-49/4·chapter-ix/section-3/article-74/8·chapter-ix/section-3/article-78/3·chapter-vi/article-60/4;eu-digital-omnibus-aiarticle-1/6 - law enforcement authority 1 clause:
eu-ai-actchapter-i/article-3 - lay person 3 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrannex-i/chapter-ii·chapter-i/article-2 - lifetime 14 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·annex-i/chapter-iii·annex-xiii/part-b·chapter-i/section-1/article-2·chapter-vii/section-1/article-81/1;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrannex-i/chapter-iii·annex-xiv/part-b·chapter-i/article-2·chapter-vii/section-1/article-86/1 - 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 25 clauses:
eu-digital-omnibus-aiarticle-1/9;eu-machinery-regulationannex-iii/part-a·annex-iii/part-b/1·annex-iii/part-b/4·annex-iii/part-b/5·annex-iii/part-b/6.1.1·annex-iii/part-b/6.1.2·annex-iii/part-b/6.3.2·annex-iv/part-a·annex-iv/part-b·annex-x/2·chapter-i/article-3·chapter-i/article-6/4·chapter-i/article-6/7·chapter-ii/article-10/9·chapter-ii/article-11/9·chapter-ii/article-13/2·chapter-ii/article-13/7·chapter-ii/article-14/2·chapter-ii/article-14/6·chapter-ii/article-15/3·chapter-ii/article-15/5·chapter-ii/article-16/3·chapter-ii/article-16/5·chapter-ii/article-18 - 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 9 clauses:
eu-ai-actchapter-i/article-3·chapter-ix/section-5/article-93/1;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2·chapter-vii/section-3/article-93/1;eu-machinery-regulationchapter-i/article-3;eu-mdrannex-i/chapter-iii·chapter-i/article-2·chapter-vii/section-3/article-98/1 - managed security service provider 1 clause:
eu-nis2chapter-i/article-6 - managed service provider 1 clause:
eu-nis2chapter-i/article-6 - manufacturer 121 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-25/3·chapter-iii/section-5/article-43/3;eu-cyber-resilience-actannex-i/part-i·chapter-i/article-12/1·chapter-i/article-3·chapter-ii/article-13/3·chapter-ii/article-13/4·chapter-ii/article-14/8·chapter-ii/article-16/2·chapter-ii/article-19/3·chapter-ii/article-19/5·chapter-ii/article-20/3·chapter-ii/article-20/4·chapter-v/article-54/6·chapter-v/article-57/1;eu-cybersecurity-acttitle-iii/article-53/1;eu-digital-omnibus-aiarticle-1/5;eu-gmp-annex-1annex-1/11;eu-gmp-annex-1410;eu-gmp-annex-1512·5.19;eu-gmp-annex-175;eu-gmp-annex-199.2;eu-gmp-annex-236;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-i/chapter-iii·annex-ii/1.1·annex-iii/1·annex-ix/chapter-i/2.2·annex-ix/chapter-i/3.2·annex-ix/chapter-ii·annex-vi/part-b·annex-vii/3.2.6·annex-vii/4.10·annex-vii/4.11·annex-vii/4.5.1·annex-vii/4.5.3·annex-vii/4.5.4·annex-vii/4.8·annex-xii/chapter-i/4·annex-xiii/part-a/1·annex-xiii/part-b·chapter-i/section-1/article-2·chapter-ii/article-10/8·chapter-ii/article-13/2·chapter-ii/article-13/7·chapter-ii/article-14/2·chapter-ii/article-14/4·chapter-iv/article-42/6·chapter-vi/article-56/1·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-84/1·chapter-vii/section-2/article-84/3·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-90/1;eu-machinery-regulationannex-iii/part-b/1·annex-iii/part-b/5·annex-iii/part-b/6.1.2·annex-iv/part-a·annex-iv/part-b·annex-x/2·chapter-i/article-3·chapter-i/article-6/7·chapter-ii/article-13/2·chapter-ii/article-14/2·chapter-ii/article-15/3·chapter-ii/article-16/3·chapter-ii/article-18;eu-mdrannex-i/chapter-ii·annex-i/chapter-iii·annex-ii/1.1·annex-iii·annex-ix/chapter-i/2.2·annex-ix/chapter-i/3.2·annex-ix/chapter-ii·annex-vi/part-b·annex-vii/3.2.6·annex-vii/4.10·annex-vii/4.11·annex-vii/4.5.1·annex-vii/4.5.3·annex-vii/4.5.4·annex-vii/4.5.5·annex-vii/4.8·annex-xii/chapter-i/4·annex-xiv/part-b·annex-xv/chapter-i/2.1·chapter-i/article-2·chapter-ii/article-10/9·chapter-ii/article-13/2·chapter-ii/article-13/7·chapter-ii/article-14/2·chapter-ii/article-14/4·chapter-iv/article-46/7·chapter-v/section-2/article-54/2·chapter-vi/article-61/1·chapter-vi/article-61/10·chapter-vi/article-71/3·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-89/1·chapter-vii/section-2/article-89/3·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-95/1;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;nistir-81837 - market surveillance 93 clauses:
ema-pics-annex15-concept1;eu-ai-actchapter-i/article-1/2·chapter-i/article-3·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-46/1·chapter-iii/section-5/article-46/3·chapter-ix/section-2/article-73/1·chapter-ix/section-3/article-74/10·chapter-ix/section-3/article-74/11·chapter-ix/section-3/article-74/12·chapter-ix/section-3/article-74/3·chapter-ix/section-3/article-74/6·chapter-ix/section-3/article-74/8·chapter-ix/section-3/article-75/2·chapter-ix/section-3/article-75/3·chapter-ix/section-3/article-77/1·chapter-ix/section-3/article-77/3·chapter-ix/section-3/article-78/3·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-83/2·chapter-vi/article-60/4·chapter-vi/article-60/6·chapter-vii/section-1/article-68/3;eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-19/3·chapter-ii/article-19/5·chapter-ii/article-20/3·chapter-ii/article-20/4·chapter-v/article-52/14·chapter-v/article-54/1·chapter-v/article-54/2·chapter-v/article-54/6·chapter-v/article-56/1·chapter-v/article-56/2·chapter-v/article-57/1;eu-digital-omnibus-aiarticle-1/6·article-1/9;eu-ivdrannex-i/chapter-i/3·annex-iii/1·annex-ix/chapter-i/3.2·annex-ix/chapter-ii·annex-vii/4.10·annex-vii/4.11·annex-vii/4.5.4·annex-vii/4.8·annex-xiii/part-b·chapter-i/section-1/article-2·chapter-ii/article-10/8·chapter-ii/article-8/1·chapter-iv/article-42/6·chapter-vii/section-1/article-78/1·chapter-vii/section-1/article-78/3·chapter-vii/section-1/article-81/1·chapter-vii/section-2/article-83/1·chapter-vii/section-3/article-89·chapter-vii/section-3/article-95/1;eu-machinery-regulationchapter-i/article-3·chapter-i/article-6/7·chapter-ii/article-13/2·chapter-ii/article-14/2·chapter-ii/article-15/3·chapter-ii/article-16/3·chapter-vi/article-43/1·chapter-vi/article-43/4·chapter-vi/article-43/5;eu-mdrannex-i/chapter-i/3·annex-iii·annex-ix/chapter-i/3.2·annex-ix/chapter-ii·annex-vii/4.10·annex-vii/4.11·annex-vii/4.5.5·annex-vii/4.8·annex-xiv/part-b·chapter-i/article-2·chapter-ii/article-10/9·chapter-ii/article-8/1·chapter-vii/section-1/article-83/1·chapter-vii/section-1/article-83/3·chapter-vii/section-1/article-86/1·chapter-vii/section-2/article-88/1·chapter-vii/section-3/article-100/1·chapter-vii/section-3/article-94 - market surveillance authority 27 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-43/1·chapter-iii/section-5/article-46/1·chapter-iii/section-5/article-46/3·chapter-ix/section-3/article-74/3·chapter-ix/section-3/article-74/6·chapter-ix/section-3/article-75/3·chapter-ix/section-3/article-77/1·chapter-ix/section-3/article-77/3·chapter-ix/section-3/article-78/3·chapter-ix/section-3/article-79/2·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-83/2·chapter-vi/article-60/4;eu-cyber-resilience-actchapter-i/article-3·chapter-v/article-54/1·chapter-v/article-54/2·chapter-v/article-54/6·chapter-v/article-57/1;eu-digital-omnibus-aiarticle-1/6·article-1/9;eu-machinery-regulationchapter-i/article-3 - medical device 11 clauses:
eu-gmp-annex-1410;eu-ivdrannex-i/chapter-iii·annex-vi/part-b·chapter-i/section-1/article-2·chapter-iii/article-24/12;eu-mdrannex-i/chapter-iii·annex-vi/part-b·chapter-i/article-2·chapter-iii/article-27/12;fda-ai-guidance7;fda-device-cybersecurity-20266 - Metadata 1 clause:
nist-ai-600-112 - micro, small and medium-sized enterprise 1 clause:
eu-digital-omnibus-aiarticle-1 - nanomaterial 1 clause:
eu-mdrchapter-i/article-2 - national accreditation body 1 clause:
eu-machinery-regulationchapter-i/article-3 - national competent authority 12 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-16·chapter-iii/section-4/article-36/9·chapter-ix/section-2/article-73/10·chapter-ix/section-3/article-78/3;eu-digital-omnibus-aiarticle-1/6·article-1/9;eu-gmp-annex-1410;eu-gmp-annex-236;eu-ivdrchapter-iv/article-42/6·chapter-vii/section-2/article-84/3;eu-mdrchapter-vii/section-2/article-89/3 - national cybersecurity strategy 2 clauses:
eu-nis2chapter-i/article-6·chapter-ii/article-7/2 - near miss 2 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-nis2chapter-i/article-6 - negative predictive value 3 clauses:
eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii·chapter-i/section-1/article-2 - network and information system 1 clause:
eu-nis2chapter-i/article-6 - non-personal data 1 clause:
eu-ai-actchapter-i/article-3 - non-viable 6 clauses:
eu-gmp-annex-1annex-1/11;eu-mdrannex-i/chapter-ii·annex-ix/chapter-ii·annex-xiv/part-a/1·annex-xv/chapter-ii/2.6·chapter-i/article-2 - notified body 59 clauses:
eu-ai-actannex-vii/4.5·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-36/3·chapter-iii/section-4/article-36/7·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-43/2·chapter-iii/section-5/article-48/4·chapter-ix/section-2/article-73/6·chapter-ix/section-3/article-79/2;eu-cyber-resilience-actchapter-i/article-3·chapter-v/article-54/1;eu-digital-omnibus-aiarticle-1/5·article-1/6;eu-ivdrannex-ix/chapter-i/2.2·annex-ix/chapter-i/3.2·annex-ix/chapter-ii·annex-vi/part-a/2.1·annex-vii/1.4.2·annex-vii/4.10·annex-vii/4.11·annex-vii/4.5.1·annex-vii/4.5.3·annex-vii/4.5.4·annex-vii/4.8·chapter-i/section-1/article-2·chapter-ii/article-10/11·chapter-ii/article-13/7·chapter-iv/article-41/2·chapter-iv/article-42/6·chapter-vii/section-2/article-84/1;eu-machinery-regulationannex-x/2·chapter-i/article-3·chapter-iii/article-24/4·chapter-vi/article-43/1;eu-mdrannex-ix/chapter-i/2.2·annex-ix/chapter-i/3.2·annex-ix/chapter-ii·annex-vi/part-a/2.1·annex-vii/1.4.2·annex-vii/4.10·annex-vii/4.11·annex-vii/4.5.1·annex-vii/4.5.3·annex-vii/4.5.4·annex-vii/4.5.5·annex-vii/4.8·chapter-i/article-2·chapter-ii/article-10/12·chapter-ii/article-13/7·chapter-iv/article-45/2·chapter-iv/article-46/7·chapter-v/section-2/article-54/2·chapter-vii/section-2/article-89/1 - notifying authority 6 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-4/article-36/3·chapter-iii/section-4/article-36/7·chapter-iii/section-4/article-36/8;eu-cyber-resilience-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/5 - 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 39 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-79/6·chapter-ix/section-3/article-82/1;eu-cyber-resilience-actchapter-i/article-3·chapter-v/article-54/1·chapter-v/article-54/6·chapter-v/article-57/1;eu-digital-omnibus-aiarticle-1/6·article-1/9;eu-gmp-annex-1annex-1/11;eu-gmp-annex-116;eu-gmp-annex-236;eu-gmp-annex-2210;eu-gmp-chapter-2part-1;eu-ivdrchapter-i/section-1/article-2·chapter-vii/section-3/article-90/1·chapter-vii/section-3/article-90/5·chapter-vii/section-3/article-92/1·chapter-vii/section-3/article-94/2;eu-machinery-regulationannex-iii/part-a·annex-iii/part-b/5·chapter-i/article-3·chapter-vi/article-43/1·chapter-vi/article-43/4·chapter-vi/article-43/5·chapter-vi/article-45/1;eu-mdrchapter-i/article-2·chapter-vii/section-3/article-95/1·chapter-vii/section-3/article-95/5·chapter-vii/section-3/article-97/1·chapter-vii/section-3/article-99/2;fda-device-cybersecurity-20266;nist-ai-600-112;nist-ai-rmf5.2·6;nistir-81837 - 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 9 clauses:
eu-machinery-regulationannex-iii/part-b/5·annex-iv/part-a·annex-iv/part-b·chapter-i/article-3·chapter-ii/article-11/9·chapter-ii/article-14/2·chapter-ii/article-14/6·chapter-ii/article-16/3·chapter-ii/article-16/5 - performance 93 clauses:
ema-pics-annex15-concept2;eu-ai-actchapter-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-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-11-draft17;eu-gmp-annex-1512;eu-gmp-annex-175;eu-gmp-annex-236;eu-gmp-annex-2210;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-i/chapter-iii·annex-iii/1·annex-ix/chapter-i/2.2·annex-ix/chapter-ii·annex-vi/part-a/2.1·annex-vii/3.2.5·annex-vii/4.10·annex-vii/4.11·annex-vii/4.5.1·annex-vii/4.5.3·annex-vii/4.5.4·annex-vii/4.8·annex-xiii/part-a/1·annex-xiii/part-a/1.1·annex-xiii/part-b·annex-xiv/chapter-i/2.6·chapter-i/section-1/article-2·chapter-ii/article-10/8·chapter-ii/article-7·chapter-ii/article-8/1·chapter-vi/article-56/1·chapter-vi/article-58/5·chapter-vi/article-60/1·chapter-vi/article-61/1·chapter-vi/article-62·chapter-vi/article-64/1·chapter-vi/article-65/1·chapter-vi/article-66/7·chapter-vi/article-67/3·chapter-vii/section-1/article-78/3·chapter-vii/section-2/article-83/1·chapter-vii/section-3/article-88/1;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-i/chapter-ii·annex-i/chapter-iii·annex-ii/1.1·annex-iii·annex-ix/chapter-i/2.2·annex-ix/chapter-ii·annex-vi/part-a/2.1·annex-vii/3.2.5·annex-vii/4.10·annex-vii/4.11·annex-vii/4.5.3·annex-vii/4.5.5·annex-xiv/part-a/1·annex-xiv/part-b·annex-xv/chapter-i/2.1·annex-xv/chapter-ii/2.6·chapter-i/article-2·chapter-ii/article-10/9·chapter-ii/article-17/3·chapter-ii/article-7·chapter-vi/article-61/1·chapter-vi/article-61/10·chapter-vi/article-62/4·chapter-vi/article-71/3·chapter-vii/section-1/article-83/3·chapter-vii/section-3/article-93/1;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;ich-q1413.2;ich-q2r2annex-2/2.2;ich-q9r125·8;nist-ai-600-112;nist-ai-rmf1.1·5.2·5.3·6;nistir-81837 - performance evaluation 17 clauses:
eu-ivdrannex-ix/chapter-i/2.2·annex-ix/chapter-ii·annex-vii/3.2.5·annex-vii/4.10·annex-vii/4.11·annex-vii/4.5.1·annex-vii/4.5.3·annex-vii/4.5.4·annex-vii/4.8·annex-xiii/part-a/1·annex-xiii/part-a/1.1·annex-xiii/part-b·chapter-i/section-1/article-2·chapter-ii/article-10/8·chapter-vi/article-56/1·chapter-vii/section-1/article-78/3;eu-mdrchapter-vi/article-61/10 - 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 13 clauses:
eu-ivdrannex-i/chapter-iii·annex-vi/part-a/2.1·annex-vii/4.5.4·chapter-i/section-1/article-2·chapter-ii/article-10/8·chapter-vi/article-58/5·chapter-vi/article-60/1·chapter-vi/article-61/1·chapter-vi/article-62·chapter-vi/article-64/1·chapter-vi/article-65/1·chapter-vi/article-66/7·chapter-vi/article-67/3 - performance study plan 4 clauses:
eu-ivdrannex-vii/4.5.4·chapter-i/section-1/article-2·chapter-vi/article-58/5·chapter-vi/article-64/1 - personal data 13 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-2/article-10/2·chapter-iii/section-2/article-10/5·chapter-iii/section-3/article-19/1·chapter-iii/section-3/article-26/10·chapter-iii/section-3/article-26/6·chapter-vi/article-60/4;eu-cyber-resilience-actchapter-i/article-3·chapter-i/article-7/2;eu-digital-omnibus-aiarticle-1·article-1/3·article-1/6;nist-ai-600-112 - physical connection 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - placing on the market 20 clauses:
eu-ai-actchapter-i/article-1/2·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-46/1·chapter-iii/section-5/article-49/1·chapter-iii/section-5/article-49/2·chapter-ix/section-3/article-74/6·chapter-v/section-3/article-55/1·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·chapter-vii/section-3/article-91/3;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrchapter-i/article-2·chapter-vii/section-3/article-96/3 - positive predictive value 2 clauses:
eu-ivdrannex-i/chapter-ii·chapter-i/section-1/article-2 - post-market monitoring system 7 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-72/4;eu-digital-omnibus-aiarticle-1/6 - post-market surveillance 32 clauses:
eu-ivdrannex-i/chapter-i/3·annex-iii/1·annex-ix/chapter-i/3.2·annex-ix/chapter-ii·annex-vii/4.10·annex-vii/4.11·annex-vii/4.5.4·annex-vii/4.8·annex-xiii/part-b·chapter-i/section-1/article-2·chapter-ii/article-10/8·chapter-ii/article-8/1·chapter-vii/section-1/article-78/1·chapter-vii/section-1/article-78/3·chapter-vii/section-1/article-81/1·chapter-vii/section-2/article-83/1;eu-mdrannex-i/chapter-i/3·annex-iii·annex-ix/chapter-i/3.2·annex-ix/chapter-ii·annex-vii/4.10·annex-vii/4.11·annex-vii/4.5.5·annex-vii/4.8·annex-xiv/part-b·chapter-i/article-2·chapter-ii/article-10/9·chapter-ii/article-8/1·chapter-vii/section-1/article-83/1·chapter-vii/section-1/article-83/3·chapter-vii/section-1/article-86/1·chapter-vii/section-2/article-88/1 - post-remote biometric identification system 2 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-26/10 - predictive value 3 clauses:
eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii·chapter-i/section-1/article-2 - procedure pack 1 clause:
eu-mdrchapter-i/article-2 - Product Lifecycle 4 clauses:
fda-ai-guidance7;ich-q124;ich-q1413.2;ich-q9r18 - product with digital elements 19 clauses:
eu-cyber-resilience-actannex-i/part-i·chapter-i/article-3·chapter-i/article-7/2·chapter-ii/article-13/3·chapter-ii/article-13/4·chapter-ii/article-14/8·chapter-ii/article-15/1·chapter-ii/article-16/2·chapter-ii/article-19/3·chapter-ii/article-19/5·chapter-ii/article-20/3·chapter-ii/article-20/4·chapter-iii/article-30/3·chapter-v/article-54/1·chapter-v/article-54/2·chapter-v/article-54/6·chapter-v/article-56/1·chapter-v/article-56/2·chapter-v/article-57/1 - professional user 3 clauses:
eu-machinery-regulationchapter-i/article-3·chapter-ii/article-18;eu-mdrchapter-i/article-2 - profiling 4 clauses:
eu-ai-actannex-iii/6·chapter-i/article-3·chapter-ii/article-5/1·chapter-iii/section-1/article-6/3 - protective device 2 clauses:
eu-machinery-regulationannex-iii/part-a·annex-iii/part-b/5 - provider 68 clauses:
ema-annex11-concept-paper1;eu-ai-actannex-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-17/2·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-34/2·chapter-iii/section-4/article-36/7·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-43/3·chapter-iii/section-5/article-43/4·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-73/4·chapter-ix/section-2/article-73/6·chapter-ix/section-3/article-74/13·chapter-ix/section-3/article-80·chapter-ix/section-3/article-80/1·chapter-ix/section-3/article-80/2·chapter-ix/section-3/article-80/7·chapter-ix/section-5/article-90/3·chapter-ix/section-5/article-92/1·chapter-ix/section-5/article-93/3·chapter-v/section-1/article-52/1·chapter-v/section-1/article-52/2·chapter-v/section-1/article-52/3·chapter-v/section-1/article-52/5·chapter-vi/article-60/4·chapter-xii/article-101/1;eu-cybersecurity-acttitle-iii/article-53/1;eu-digital-omnibus-aiarticle-1/3·article-1/4·article-1/5·article-1/6·article-1/9;eu-gmp-annex-113.2;eu-gmp-annex-11-draft17;eu-gmp-annex-2210;eu-nis2chapter-i/article-2/2·chapter-i/article-6·chapter-iv/article-21/3;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 26 clauses:
eu-ai-actchapter-i/article-1/2·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-46/1·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·chapter-ii/article-7·chapter-vi/article-67/3·chapter-vii/section-3/article-91/3·chapter-vii/section-3/article-93/1;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrchapter-i/article-2·chapter-ii/article-7·chapter-vi/article-71/3·chapter-vii/section-3/article-96/3·chapter-vii/section-3/article-98/1 - qualified trust service 1 clause:
eu-nis2chapter-i/article-6 - qualified trust service provider 1 clause:
eu-nis2chapter-i/article-6 - Quality 28 clauses:
ema-annex11-concept-paper1;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-1410;eu-gmp-annex-1511.4·12;eu-gmp-annex-161.5.6·1.5.7·2.2;eu-gmp-annex-175;eu-gmp-annex-236;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;fda-ai-guidance7;fda-device-cybersecurity-20266;fda-electronic-systems-clinical12;ich-q124;ich-q1413.2;ich-q2r2annex-2/1.2;ich-q9r125·8;nistir-81837 - Quality Risk Management 15 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-161.5.6·1.5.7·2.2;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-electronic-systems-clinical12;ich-q124;ich-q1413.2;ich-q9r18 - Quality System 13 clauses:
ema-annex11-concept-paper1;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-175;eu-gmp-annex-215.1.1;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 4 clauses:
eu-ai-actchapter-i/article-3·chapter-vi/article-60/1·chapter-vi/article-60/4;eu-digital-omnibus-aiarticle-1/6 - reasonably foreseeable misuse 13 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-a·annex-iii/part-b/1·annex-iii/part-b/5·chapter-i/article-6/4;eu-mdrannex-i/chapter-i/3;fda-device-cybersecurity-20266 - reasonably foreseeable use 2 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-13/3 - recall 36 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-5/article-93/1;eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-19/5·chapter-ii/article-20/4·chapter-v/article-54/1;eu-digital-omnibus-aiarticle-1/6;eu-gmp-annex-199.2;eu-gmp-annex-236;eu-gmp-chapter-1chapter-1;eu-gmp-chapter-8part-1;eu-ivdrchapter-i/section-1/article-2·chapter-ii/article-10/11·chapter-ii/article-13/7·chapter-ii/article-14/4·chapter-vii/section-3/article-90/1;eu-machinery-regulationchapter-i/article-3·chapter-ii/article-10/9·chapter-ii/article-11/9·chapter-ii/article-13/7·chapter-ii/article-14/6·chapter-ii/article-15/5·chapter-ii/article-16/5·chapter-vi/article-45/1;eu-mdrchapter-i/article-2·chapter-ii/article-10/12·chapter-ii/article-13/7·chapter-ii/article-14/4·chapter-vii/section-3/article-95/1;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 2 clauses:
eu-ai-actchapter-i/article-3·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 71 clauses:
eu-ai-actannex-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-22/1·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;eu-cyber-resilience-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/6;eu-gmp-annex-1annex-1/11;eu-gmp-annex-161.5.6·1.5.7;eu-gmp-annex-175;eu-gmp-annex-236;eu-gmp-annex-2210;eu-gmp-chapter-6part-1;eu-ivdrannex-i/chapter-iii·annex-ix/chapter-i/2.2·annex-ix/chapter-i/3.2·annex-vi/part-b·annex-vii/4.5.1·chapter-i/section-1/article-2·chapter-ii/article-10/11·chapter-ii/article-13/2·chapter-ii/article-13/7·chapter-ii/article-14/2·chapter-ii/article-14/4·chapter-iv/article-41/2·chapter-v/section-2/article-48/13·chapter-vi/article-58/5·chapter-vi/article-60/1·chapter-vi/article-61/1·chapter-vi/article-64/1·chapter-vii/section-2/article-85·chapter-vii/section-3/article-90/1;eu-machinery-regulationannex-iii/part-b/5·annex-x/2·chapter-i/article-3;eu-mdrannex-i/chapter-iii·annex-ix/chapter-i/2.2·annex-ix/chapter-i/3.2·annex-vi/part-b·annex-vii/4.5.1·chapter-i/article-2·chapter-ii/article-10/12·chapter-ii/article-13/2·chapter-ii/article-13/7·chapter-ii/article-14/2·chapter-ii/article-14/4·chapter-iv/article-45/2·chapter-v/section-2/article-52/14·chapter-vi/article-62/4·chapter-vi/article-68/1·chapter-vii/section-2/article-90·chapter-vii/section-3/article-95/1;eu-nis2chapter-i/article-6;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;ich-q1413.2;ich-q2r2annex-2/2.2;nist-ai-600-112;nist-ai-rmf3.7;nistir-81837 - reprocessing 7 clauses:
eu-gmp-annex-1410;eu-gmp-chapter-5part-1;eu-gmp-chapter-6part-1;eu-mdrannex-i/chapter-iii·chapter-i/article-2·chapter-ii/article-17/3;ich-q9r125 - Requirements 11 clauses:
ema-pics-annex15-concept1·2;eu-ai-actchapter-iii/section-2;eu-gmp-annex-1annex-1/11;eu-gmp-annex-114.4;eu-gmp-annex-11-draft17;eu-gmp-annex-1410;eu-machinery-regulationannex-iii/part-b/5;fda-device-cybersecurity-20266;ich-q124;nistir-81837 - research organisation 1 clause:
eu-nis2chapter-i/article-6 - Risk Acceptance 1 clause:
ich-q9r18 - Risk Analysis 1 clause:
ich-q9r18 - Risk Assessment 5 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20262·6;ich-q9r18;nistir-81837 - Risk Control 1 clause:
ich-q9r18 - Risk Evaluation 1 clause:
ich-q9r18 - Risk Management 25 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-111;eu-gmp-annex-11-draft17·4;eu-gmp-annex-161.5.6·1.5.7·2.2;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-20261·6;fda-electronic-systems-clinical12;ich-q124;ich-q1413.2;ich-q9r18;nist-ai-600-112·3;nist-ai-rmf6;nistir-81836·6.3·7 - 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 6 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-1/article-6/1;eu-digital-omnibus-aiarticle-1·article-1/5·article-3;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 1 clause:
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-ix/section-3/article-78/3 - serious adverse event 4 clauses:
eu-gmp-annex-1410;eu-gmp-annex-236;eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - serious incident 16 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-73/1·chapter-ix/section-2/article-73/4·chapter-ix/section-2/article-73/6;eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2·chapter-vii/section-2/article-84/1·chapter-vii/section-2/article-84/3·chapter-vii/section-2/article-84/7;eu-mdrannex-i/chapter-iii·chapter-i/article-2·chapter-vii/section-2/article-89/1·chapter-vii/section-2/article-89/3·chapter-vii/section-2/article-89/7 - serious public health threat 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - significant cyber threat 3 clauses:
eu-nis2chapter-i/article-6·chapter-vii/article-32/4·chapter-vii/article-33/4 - significant cybersecurity risk 14 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-19/3·chapter-ii/article-19/5·chapter-ii/article-20/3·chapter-ii/article-20/4·chapter-v/article-54·chapter-v/article-54/1·chapter-v/article-54/2·chapter-v/article-56·chapter-v/article-56/1·chapter-v/article-56/2·chapter-v/article-57·chapter-v/article-57/1;fda-device-cybersecurity-20266 - single-use device 5 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrannex-i/chapter-iii·annex-vi/part-a/2.1·annex-vi/part-b·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 30 clauses:
ema-annex11-concept-paper1;eu-ai-actchapter-iii/section-2/article-13/3;eu-cyber-resilience-actchapter-i/article-3;eu-gmp-annex-11-draft17;eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii·annex-ii/1.1·annex-vii/3.2.5·annex-xiii/part-a/1.1·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-i/chapter-iii·annex-ii/1.1·annex-vii/3.2.5·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 1 clause:
eu-cyber-resilience-actchapter-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-2/article-10/5;eu-digital-omnibus-aiarticle-1/3 - specimen receptacle 1 clause:
eu-ivdrchapter-i/section-1/article-2 - sponsor 10 clauses:
eu-gmp-chapter-8part-1;eu-ivdrchapter-i/section-1/article-2·chapter-vi/article-58/5·chapter-vi/article-66/7·chapter-vi/article-67/3;eu-mdrchapter-i/article-2·chapter-vi/article-62/4·chapter-vi/article-71/3;fda-ai-guidance7;fda-device-cybersecurity-20266 - Stakeholder 1 clause:
nist-ai-600-112 - standard 24 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-5/article-43/1·chapter-v/section-3/article-55/2;eu-cyber-resilience-actchapter-i/article-3;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-ivdrchapter-i/section-1/article-2·chapter-vi/article-60/1·chapter-vi/article-61/1·chapter-vi/article-64/1;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrchapter-i/article-2·chapter-vi/article-68/1;eu-nis2chapter-i/article-6;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q1413.2;ich-q9r18;nist-ai-600-112;nist-ai-rmf6 - Static test 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - subject 83 clauses:
ema-annex11-concept-paper1;eu-ai-actannex-vii/4.5·chapter-i/article-3·chapter-iii/section-1/article-6/4·chapter-iii/section-2/article-10/2·chapter-iii/section-2/article-10/5·chapter-iii/section-2/article-9/10·chapter-iii/section-3/article-17/3·chapter-iii/section-3/article-19/2·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-43/6·chapter-iii/section-5/article-47/3·chapter-iii/section-5/article-48/5·chapter-ix/section-1/article-72/4·chapter-ix/section-2/article-73/9·chapter-ix/section-3/article-74/12·chapter-ix/section-3/article-80/7·chapter-ix/section-4/article-86/1·chapter-vi/article-60/4·chapter-xiii/article-111/2;eu-cyber-resilience-actchapter-i/article-12/3·chapter-i/article-3·chapter-i/article-8/1·chapter-ii/article-13/4·chapter-ii/article-16/2;eu-digital-omnibus-aiarticle-1/3·article-1/6·article-1/9;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-131;eu-gmp-annex-1410;eu-gmp-annex-1512;eu-gmp-annex-175;eu-gmp-annex-225·36;eu-gmp-annex-2210;eu-gmp-annex-611;eu-gmp-chapter-2part-1;eu-gmp-chapter-6part-1;eu-ivdrannex-i/chapter-ii·annex-iii/1·chapter-i/section-1/article-2·chapter-vi/article-58/5·chapter-vi/article-60/1·chapter-vi/article-61/1·chapter-vi/article-64/1·chapter-vi/article-65/1·chapter-vi/article-66/7·chapter-vii/section-3/article-90/1·chapter-vii/section-3/article-93/1;eu-machinery-regulationannex-iii/part-a·annex-iii/part-b/5·chapter-ii/article-18;eu-mdrannex-iii·chapter-i/article-2·chapter-vi/article-62/4·chapter-vi/article-68/1·chapter-vi/article-69/1·chapter-vii/section-3/article-95/1·chapter-vii/section-3/article-98/1;eu-nis2chapter-i/article-6·chapter-iii/article-19/8·chapter-iv/article-22/2·chapter-vii/article-32/2·chapter-vii/article-33/2;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;ich-q1413.2;ich-q9r18;nist-ai-600-112·3·9;nist-ai-rmf5.3·6 - 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;eu-cyber-resilience-actchapter-i/article-3;eu-machinery-regulationchapter-i/article-3·chapter-ii/article-18 - Supervisor 3 clauses:
eu-ai-actchapter-i/article-3;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 2 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-13/3 - System / system 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 - systemic risk 22 clauses:
eu-ai-actannex-xi/section-2·annex-xiii·chapter-i/article-3·chapter-ix/section-5/article-90/3·chapter-ix/section-5/article-92/1·chapter-ix/section-5/article-93/1·chapter-ix/section-5/article-93/3·chapter-v/section-1/article-51·chapter-v/section-1/article-51/1·chapter-v/section-1/article-52/1·chapter-v/section-1/article-52/2·chapter-v/section-1/article-52/3·chapter-v/section-1/article-52/5·chapter-v/section-1/article-52/6·chapter-v/section-3·chapter-v/section-3/article-55·chapter-v/section-3/article-55/1·chapter-v/section-3/article-55/2·chapter-vii/section-1/article-68/3·chapter-xii/article-101/1;eu-cyber-resilience-actchapter-ii/article-16/2;eu-nis2chapter-i/article-2/2 - technical specification 1 clause:
eu-nis2chapter-i/article-6 - technical specifications 8 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-17/1;eu-cybersecurity-acttitle-iii/article-52/4;eu-machinery-regulationannex-iv/part-a·annex-iv/part-b·chapter-i/article-3;eu-mdrannex-ii/1.1;eu-nis2chapter-iii/article-14/4 - Test coefficient 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - testing data 9 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-2/article-10/1·chapter-iii/section-2/article-10/2·chapter-iii/section-2/article-10/3·chapter-iii/section-2/article-10/6·chapter-iii/section-2/article-13/3·chapter-ix/section-3/article-74/12;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 8 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-2/article-15/5;eu-gmp-annex-2210;fda-ai-guidance7;nist-ai-600-112·3·9;nist-ai-rmf3.3 - Trend 1 clause:
eu-gmp-chapter-6part-1 - trust service 3 clauses:
eu-cybersecurity-acttitle-ii/chapter-ii/article-5;eu-nis2chapter-i/article-2/2·chapter-i/article-6 - trust service provider 1 clause:
eu-nis2chapter-i/article-6 - UDI 21 clauses:
eu-ivdrannex-i/chapter-iii·annex-ii/1.1·annex-vi/part-a/2.1·annex-vi/part-b·annex-xii/chapter-i/4·chapter-i/section-1/article-2·chapter-ii/article-10/8·chapter-ii/article-13/2·chapter-ii/article-14/2·chapter-iii/article-24/12;eu-mdrannex-i/chapter-iii·annex-ii/1.1·annex-vi/part-a/2.1·annex-vi/part-b·annex-xii/chapter-i/4·chapter-i/article-2·chapter-ii/article-10/9·chapter-ii/article-13/2·chapter-ii/article-14/2·chapter-iii/article-27/12;fda-device-cybersecurity-20266 - Union harmonisation legislation 25 clauses:
eu-ai-actchapter-i/article-2/2·chapter-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-43/3·chapter-iii/section-5/article-46/7·chapter-iii/section-5/article-47/3·chapter-ix/section-1/article-72/4·chapter-ix/section-3/article-74/10·chapter-ix/section-3/article-74/3·chapter-ix/section-3/article-79/2·chapter-vi/article-60/1;eu-cyber-resilience-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1·article-1/5·article-1/6·article-1/9;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 32 clauses:
ema-annex11-concept-paper1;eu-cyber-resilience-actannex-i/part-i;eu-digital-omnibus-aiarticle-1/3;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-1512;eu-gmp-annex-2210;eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii·annex-ii/1.1·annex-ix/chapter-ii·chapter-i/section-1/article-2·chapter-ii/article-7;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3·chapter-ii/article-18;eu-mdrannex-i/chapter-ii·annex-i/chapter-iii·annex-ii/1.1·annex-ix/chapter-ii·chapter-i/article-2·chapter-ii/article-7;eu-nis2chapter-i/article-6;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-600-112·3;nist-ai-rmf3.5·5·5.2·6;nistir-81837 - validation data 3 clauses:
eu-ai-actchapter-i/article-3;ich-q124;ich-q1413.2 - validation data set 1 clause:
eu-ai-actchapter-i/article-3 - vulnerability 17 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-13/3·chapter-ii/article-14/8·chapter-ii/article-15/1·chapter-ii/article-16/2·chapter-ii/article-19/5·chapter-ii/article-20/4·chapter-v/article-54/1;eu-gmp-annex-11-draft17;eu-nis2chapter-i/article-6·chapter-ii/article-11/3·chapter-ii/article-7/2·chapter-iii/article-14/4·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 13 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-4/article-36/7·chapter-iii/section-4/article-36/9;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;eu-machinery-regulationchapter-i/article-3;eu-mdrannex-vii/4.8·chapter-i/article-2·chapter-iv/article-46/7 - 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 33 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-17/1·chapter-iii/section-3/article-22/1·chapter-iii/section-3/article-25/4·chapter-iii/section-5/article-47/1;eu-cyber-resilience-actchapter-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-1410;eu-gmp-annex-162.2;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-i/chapter-iii·annex-ix/chapter-i/2.2·chapter-i/section-1/article-2·chapter-iv/article-42/6;eu-machinery-regulationannex-iii/part-b/5·annex-x/2·chapter-i/article-3;eu-mdrannex-i/chapter-iii·annex-ix/chapter-i/2.2·annex-ix/chapter-ii·chapter-i/article-2;ich-q124;nist-ai-600-112·3
History
Every text of each row holding the term in any text the store holds under the current version, in the order the texts were first observed. A row’s current text is marked.
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
17bed942038f unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
6d68d146b07c (current) | 0 | 3 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
90f72782b398 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
ebaf707c409d (current) | 0 | 31 | 16 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
08b4462d76fa unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
acd195a087c3 (current) | 0 | 2 | 5 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
208b17ec5cbe | 0 | 0 | 1 | |
4f4cdfc13143 (current) | 0 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
58dbc3006d27 | 1 | 363 | 82 | |
9d16077b1d3b (current) | 1 | 363 | 82 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
9206a43954eb (current) | 0 | 73 | 16 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
1fe6027daa2c (current) | 0 | 19 | 3 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
92eb86f25281 (current) | 0 | 52 | 35 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
2f3d52a59156 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
1d99797d3b8b (current) | 0 | 77 | 14 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
797a882ba0ea | 0 | 1 | 3 | |
53742d793b68 (current) | 0 | 9 | 1 | |
ac0054416554 | 0 | 1 | 3 | |
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f110d5d47c11 | 0 | 1 | 3 | |
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| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
0e885238d69a unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
7a8b8a6e95d5 (current) | 0 | 21 | 8 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
791686510e26 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
b3718fa9a670 (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
48f21f2e4f1b unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
c4635c9c95ba (current) | 0 | 5 | 2 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
6eabc41e8879 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
ea32c21545ee (current) | 0 | 8 | 2 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
50a728365a3b unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
db59da980bed (current) | 0 | 16 | 3 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
c69969906e63 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
2f7bb1a97c67 (current) | 0 | 7 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
d15b6167fee9 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
507358780b13 (current) | 0 | 7 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
4aafde337ab3 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
fecd3a76fef8 (current) | 0 | 1 | 1 |
| 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 | 14 | 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 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
797a882ba0ea | 0 | 1 | 3 | |
07dc6a9975d1 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
f8b98469078e (current) | 0 | 2 | 0 |
| 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 | 6 | 1 |
| 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 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
4c8e3b813576 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
7d0523189210 (current) | 0 | 1 | 0 |
| 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 | 5 | 8 |
| 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 | 1 | 1 |
| 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 | 7 | 1 |
| 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 | 0 | 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 | 30 | 11 |
| 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 | 13 | 6 |
| 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 | 5 | 0 |
| 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 | 1 | 0 |
| 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 | 15 | 2 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
903e40aaebe6 (current) | 1 | 101 | 17 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
1fc20ae2ffd8 | 1 | 105 | 8 | |
82fb682a6c54 (current) | 1 | 105 | 8 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
14d00b77d5c8 | 1 | 115 | 9 | |
fab624c8e1dc (current) | 1 | 115 | 9 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
023dc18395dc (current) | 1 | 67 | 13 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
61d4603ff66e | 0 | 0 | 0 | |
088a7a37c55d | 0 | 0 | 0 | |
630bd27c7b42 | 0 | 0 | 0 | |
5c61f4c6351d (current) | 0 | 22 | 39 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
7d8bfb6d13ca | 0 | 0 | 1 | |
a55b6f369034 | 0 | 0 | 1 | |
f0d90446093e (current) | 0 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
b8cd8587b556 (current) | 0 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
4843091843f0 (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
b52b706d5cca (current) | 0 | 0 | 1 | |
d34d8c706d88 | 0 | 65 | 89 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
b52b706d5cca | 0 | 0 | 1 | |
27c5d1a28e3d unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
d34d8c706d88 (current) | 0 | 65 | 89 |
| 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 | 11 | 8 |
| 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 | 7 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
a5590943862c (current) | 0 | 1 | 7 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
d1889be52428 (current) | 0 | 1 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
2988351a1019 | 0 | 0 | 7 | |
f34e637e74cb (current) | 0 | 0 | 7 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
206fc2d61445 (current) | 0 | 22 | 27 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
06273204f50b (current) | 0 | 5 | 18 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
5e9388123e17 (current) | 0 | 18 | 59 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
bb656b9e84a8 (current) | 0 | 1 | 2 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
57c484f5daed (current) | 1 | 38 | 291 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
c0ab0e6263b3 | 0 | 0 | 4 | |
edcebd0e3a36 | 0 | 0 | 4 | |
9d19d28e1a57 | 0 | 0 | 4 | |
f2734caa33bb | 0 | 0 | 4 | |
8727e7836a62 | 0 | 0 | 4 | |
e6bfd1f64b25 | 0 | 0 | 0 | |
67d33a19b1a7 | 0 | 0 | 0 | |
05c0bdbc196e | 0 | 0 | 0 | |
8e07db344887 | 0 | 0 | 0 | |
84a3e0382b0e | 0 | 0 | 0 | |
6f9c326c480f | 0 | 0 | 0 | |
b413d56295e8 | 0 | 0 | 0 | |
e3d94d289c0b | 0 | 0 | 0 | |
d800e5bf4d9b (current) | 0 | 0 | 0 |
| 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 | 11 | 94 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
8afebcc0941a | 0 | 0 | 18 | |
c240f2675bd3 | 0 | 0 | 18 | |
4c10dc03228b (current) | 0 | 20 | 85 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
770a1e5f76c1 | 0 | 0 | 1 | |
ed70ef992f63 (current) | 0 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
40d2cc7c3de3 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
58453f40334e | 0 | 0 | 5 | |
9ab6869e7569 (current) | 0 | 0 | 5 |
| 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 | 4 | 82 |
Feed
/atom/term/risk.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 AI Act | true | open | true | true |
| EU IVDR | true | open | true | true |
| EU Machinery Regulation | true | open | true | true |
| EU MDR | true | open | true | true |
| EU NIS2 Directive | true | open | true | true |
| ICH Q9(R1) | true | open | true | true |
| EU Cybersecurity Act | true | open | true | true |
| 21 CFR Part 11 | true | open | true | true |
| EU Cyber Resilience 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 |
| 21 CFR Part 820 (QMSR) | true | open | true | true |
| Regulation (EU) 2026/1744 | true | open | true | true |
| ICH Q13 | 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: