performance
shared term, no equivalence asserted
The rows below print this term in 3 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 1 definition in this view are quoted and 1 is withheld with the reason. No reading here says that two of them agree or differ.
EU
- Defined in
- EU MDR
chapter-i/article-2(22): text withheld (over the cap: its term and text are 17 words) - Rows printing it in a normative sentence
- 21
- Rows printing it in a title
- 0
- Rows printing it in body
- 16
International
- Defined in
- no current text of a row of this jurisdiction defines it
- Rows printing it in a normative sentence
- 5
- Rows printing it in a title
- 0
- Rows printing it in body
- 8
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
- 7
This form is printed by the
tracked documents, each as a document defines it. The index’s key is
performance (the definitions derivation’s fold:
case set aside, spaces collapsed; each form is matched exactly as printed).
2 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
1 definition in 1 current text, as the definitions derivation’s rules read them, quoted where the term and its text together sit under the quote cap.
- EU MDR
EUtext first observedchapter-i/article-2(22)performance: text withheld (over the cap: its term and text are 17 words)
In normative sentences
622 sentences in 34 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.
- EMA CT computerised systems
EU6 sentences; text first observedid repeats in this text: 1 sentence (should) · follows a withheld heading: 2 sentences (should) · id repeats in this text: 3 sentences (should, may) - EMA data quality framework
EU1 sentence; text first observed10: 1 sentence (should) - EU AI Act
EU28 sentences; text first observedno clause anchor before this sentence: 11 sentences (may, should) ·chapter-i/article-3: 1 sentence (may, shall) ·chapter-iii/section-2/article-13/3: 1 sentence (shall, may) ·chapter-iii/section-2/article-14/4: 1 sentence (shall) ·chapter-iii/section-2/article-15/2: 1 sentence (shall) ·chapter-iii/section-2/article-15/5: 1 sentence (shall) ·chapter-iii/section-4/article-28/7: 1 sentence (shall) ·chapter-iii/section-4/article-31/3: 1 sentence (shall) ·chapter-iii/section-4/article-31/7: 1 sentence (shall) ·chapter-iii/section-4/article-31/8: 1 sentence (shall) ·chapter-iii/section-5/article-40/2: 1 sentence (shall) ·chapter-iii/section-5/article-43/4: 1 sentence (shall) ·chapter-v/section-4/article-56/4: 1 sentence (shall) ·chapter-v/section-4/article-56/5: 2 sentences (shall) ·chapter-vii/section-1/article-68/5: 1 sentence (shall) ·chapter-ix/section-1/article-72/2: 1 sentence (shall, may) ·chapter-x/article-95/2: 1 sentence (shall) - EU Cyber Resilience Act
EU7 sentences; text first observedno clause anchor before this sentence: 4 sentences (should) ·chapter-iv/article-37/6: 1 sentence (shall) ·chapter-iv/article-39/6: 1 sentence (shall) ·chapter-v/article-60/3: 1 sentence (may, shall) - EU Cybersecurity Act
EU13 sentences; text first observedno clause anchor before this sentence: 1 sentence (should) ·title-ii/chapter-iii/section-1/article-15/1: 1 sentence (shall, may) ·title-ii/chapter-iii/section-3/article-20/1: 1 sentence (shall) ·title-ii/chapter-iii/section-3/article-20/2: 2 sentences (shall, may) ·title-ii/chapter-iii/section-4/article-21/5: 1 sentence (shall) ·title-ii/chapter-iii/section-5/article-24/5: 1 sentence (shall) ·title-ii/chapter-iii/section-5/article-24/7: 1 sentence (shall) ·title-ii/chapter-iii/section-5/article-27/4: 1 sentence (shall) ·title-ii/chapter-v/article-36/5: 1 sentence (shall) ·title-ii/chapter-vi/article-39/3: 1 sentence (shall) ·title-iii/article-58/8: 1 sentence (shall) ·title-iv/article-69/10: 1 sentence (shall) - Regulation (EU) 2026/1744
EU2 sentences; text first observedarticle-1/3: 1 sentence (shall) ·article-1/6: 1 sentence (shall) - EU GMP Annex 1
EU8 sentences; text first observedannex-1/11: 8 sentences (should, may) - EU GMP Annex 11
EU2 sentences; text first observed4.6: 1 sentence (should) ·11: 1 sentence (should) - EU GMP Annex 11 (draft)
EU3 sentences; text first observed17: 3 sentences (should, may) - EU GMP Annex 15
EU2 sentences; text first observed5.30: 1 sentence (may) ·10.5: 1 sentence (should) - EU GMP Annex 21
EU1 sentence; text first observed5.4: 1 sentence (should) - EU GMP Annex 22
EU10 sentences; text first observed10: 8 sentences (may, should) ·10.3: 1 sentence (should) ·10.5: 1 sentence (may) - EU GMP Annex 3
EU1 sentence; text first observed19: 1 sentence (should) - EU GMP Chapter 1
EU1 sentence; text first observedchapter-1: 1 sentence (should) - EU GMP Chapter 5
EU1 sentence; text first observedpart-1: 1 sentence (should) - EU GMP Chapter 6
EU1 sentence; text first observedpart-1: 1 sentence (should) - EU GMP Chapter 7
EU1 sentence; text first observedno numbering read: 1 sentence (should) - EU IVDR
EU319 sentences; text first observedno clause anchor before this sentence: 33 sentences (should) ·chapter-i/section-1/article-1/6: 1 sentence (shall) ·chapter-i/section-1/article-2: 1 sentence (shall, may) ·chapter-ii/article-5/2: 1 sentence (shall) ·chapter-ii/article-5/3: 1 sentence (shall) ·chapter-ii/article-5/4: 1 sentence (shall) ·chapter-ii/article-5/5: 1 sentence (shall) ·chapter-ii/article-7: 1 sentence (shall, may) ·chapter-ii/article-8/1: 1 sentence (shall) ·chapter-ii/article-9/1: 1 sentence (may) ·chapter-ii/article-9/3: 1 sentence (shall) ·chapter-ii/article-10/3: 1 sentence (shall) ·chapter-ii/article-10/5: 1 sentence (shall) ·chapter-ii/article-10/8: 2 sentences (shall) ·chapter-ii/article-13/5: 1 sentence (shall) ·chapter-ii/article-15/3: 1 sentence (shall) ·chapter-ii/article-18/1: 1 sentence (shall) ·chapter-ii/article-19/1: 1 sentence (shall) ·chapter-ii/article-20/1: 1 sentence (shall) ·chapter-ii/article-20/2: 1 sentence (shall) ·chapter-iii/article-24/1: 1 sentence (shall) ·chapter-iii/article-24/3: 2 sentences (shall, must) ·chapter-iii/article-29/1: 3 sentences (shall) ·chapter-iii/article-29/2: 1 sentence (shall) ·chapter-iii/article-29/3: 1 sentence (may) ·chapter-iii/article-30/2: 1 sentence (shall) ·chapter-iv/article-31/6: 1 sentence (shall) ·chapter-iv/article-40/8: 1 sentence (shall) ·chapter-iv/article-41/1: 1 sentence (shall) ·chapter-iv/article-41/3: 1 sentence (shall) ·chapter-iv/article-41/5: 1 sentence (may) ·chapter-iv/article-41/6: 1 sentence (may) ·chapter-v/section-2/article-48/3: 1 sentence (shall) ·chapter-v/section-2/article-48/4: 1 sentence (may) ·chapter-v/section-2/article-48/5: 1 sentence (shall) ·chapter-v/section-2/article-48/6: 2 sentences (shall) ·chapter-v/section-2/article-48/7: 1 sentence (shall) ·chapter-v/section-2/article-48/8: 1 sentence (may) ·chapter-v/section-2/article-48/9: 1 sentence (shall) ·chapter-v/section-2/article-48/10: 1 sentence (shall) ·chapter-v/section-2/article-48/11: 1 sentence (shall) ·chapter-v/section-2/article-50/1: 1 sentence (shall) ·chapter-v/section-2/article-50/3: 1 sentence (may) ·chapter-v/section-2/article-52: 1 sentence (shall) ·chapter-vi/article-56/1: 3 sentences (shall) ·chapter-vi/article-56/2: 1 sentence (shall) ·chapter-vi/article-56/3: 2 sentences (shall) ·chapter-vi/article-56/4: 1 sentence (shall) ·chapter-vi/article-56/5: 2 sentences (shall) ·chapter-vi/article-56/6: 3 sentences (shall) ·chapter-vi/article-57/1: 1 sentence (shall) ·chapter-vi/article-57/2: 1 sentence (shall) ·chapter-vi/article-57/3: 2 sentences (shall) ·chapter-vi/article-58/1: 1 sentence (shall) ·chapter-vi/article-58/2: 1 sentence (shall) ·chapter-vi/article-58/3: 1 sentence (shall) ·chapter-vi/article-58/4: 2 sentences (shall, may) ·chapter-vi/article-58/5: 1 sentence (may) ·chapter-vi/article-58/6: 1 sentence (may) ·chapter-vi/article-58/7: 1 sentence (shall) ·chapter-vi/article-58/8: 1 sentence (shall) ·chapter-vi/article-59/2: 2 sentences (shall) ·chapter-vi/article-59/6: 1 sentence (shall) ·chapter-vi/article-59/7: 1 sentence (shall) ·chapter-vi/article-60/1: 1 sentence (may) ·chapter-vi/article-60/3: 1 sentence (shall) ·chapter-vi/article-61/1: 1 sentence (may, shall) ·chapter-vi/article-61/2: 1 sentence (shall) ·chapter-vi/article-62: 1 sentence (may) ·chapter-vi/article-63: 1 sentence (may) ·chapter-vi/article-64/1: 1 sentence (may) ·chapter-vi/article-64/2: 2 sentences (shall) ·chapter-vi/article-64/3: 1 sentence (shall) ·chapter-vi/article-65/1: 1 sentence (shall) ·chapter-vi/article-65/2: 1 sentence (shall) ·chapter-vi/article-66/1: 3 sentences (shall) ·chapter-vi/article-66/3: 2 sentences (shall) ·chapter-vi/article-66/7: 1 sentence (may) ·chapter-vi/article-67/1: 1 sentence (shall) ·chapter-vi/article-67/3: 2 sentences (shall) ·chapter-vi/article-67/4: 1 sentence (shall) ·chapter-vi/article-68/1: 1 sentence (shall) ·chapter-vi/article-68/2: 2 sentences (shall) ·chapter-vi/article-68/3: 1 sentence (shall) ·chapter-vi/article-68/5: 1 sentence (shall) ·chapter-vi/article-69/1: 1 sentence (shall) ·chapter-vi/article-69/2: 1 sentence (shall) ·chapter-vi/article-69/3: 1 sentence (shall) ·chapter-vi/article-70/1: 1 sentence (shall) ·chapter-vi/article-70/2: 1 sentence (shall) ·chapter-vi/article-71/1: 1 sentence (shall) ·chapter-vi/article-71/2: 1 sentence (shall) ·chapter-vi/article-71/3: 1 sentence (may) ·chapter-vi/article-72/1: 1 sentence (may) ·chapter-vi/article-72/3: 1 sentence (shall) ·chapter-vi/article-73/1: 2 sentences (shall) ·chapter-vi/article-73/2: 1 sentence (shall) ·chapter-vi/article-73/3: 2 sentences (shall) ·chapter-vi/article-73/4: 2 sentences (shall) ·chapter-vi/article-73/5: 4 sentences (shall) ·chapter-vi/article-73/6: 2 sentences (shall, may) ·chapter-vi/article-73/7: 2 sentences (shall) ·chapter-vi/article-74/1: 1 sentence (may) ·chapter-vi/article-74/2: 2 sentences (shall) ·chapter-vi/article-74/4: 1 sentence (shall) ·chapter-vi/article-74/7: 1 sentence (may) ·chapter-vi/article-74/8: 2 sentences (shall, may) ·chapter-vi/article-74/9: 1 sentence (shall) ·chapter-vi/article-74/10: 1 sentence (shall) ·chapter-vi/article-74/11: 2 sentences (shall, may) ·chapter-vi/article-74/14: 1 sentence (shall) ·chapter-vi/article-76/1: 1 sentence (shall) ·chapter-vi/article-76/2: 2 sentences (shall) ·chapter-vi/article-76/3: 1 sentence (shall) ·chapter-vi/article-76/4: 3 sentences (shall) ·chapter-vi/article-76/6: 1 sentence (shall) ·chapter-vi/article-77: 1 sentence (may) ·chapter-vii/section-1/article-78/2: 1 sentence (shall) ·chapter-vii/section-1/article-78/3: 1 sentence (shall) ·chapter-vii/section-2/article-82/1: 1 sentence (shall) ·chapter-vii/section-2/article-83/1: 2 sentences (shall, may) ·chapter-vii/section-3/article-88/1: 1 sentence (shall) ·chapter-viii/article-96: 1 sentence (shall) ·chapter-viii/article-99: 1 sentence (shall) ·chapter-viii/article-100/2: 1 sentence (shall) ·chapter-viii/article-100/3: 1 sentence (may) ·chapter-viii/article-101: 1 sentence (shall) ·chapter-x/article-113/3: 1 sentence (shall) ·annex-i/chapter-i/1: 1 sentence (shall) ·annex-i/chapter-i/6: 1 sentence (shall) ·annex-i/chapter-i/7: 1 sentence (shall) ·annex-i/chapter-i/8: 1 sentence (shall) ·annex-i/chapter-ii: 12 sentences (shall) ·annex-i/chapter-iii: 5 sentences (shall, may, should) ·annex-ii/4: 2 sentences (shall) ·annex-ii/6: 1 sentence (shall) ·annex-ii/6.2: 2 sentences (shall) ·annex-ii/6.5: 1 sentence (shall) ·annex-iii/1: 1 sentence (shall) ·annex-vi/part-a/2.1: 1 sentence (shall) ·annex-vi/part-c/6.2.2: 1 sentence (shall) ·annex-vii/1.1.4: 1 sentence (shall) ·annex-vii/1.1.5: 1 sentence (shall, may) ·annex-vii/1.1.6: 1 sentence (shall) ·annex-vii/1.3.1: 1 sentence (shall) ·annex-vii/3.1.1: 1 sentence (shall) ·annex-vii/3.2.1: 1 sentence (shall) ·annex-vii/3.2.2: 1 sentence (shall) ·annex-vii/3.2.4: 1 sentence (shall) ·annex-vii/3.2.5: 1 sentence (shall) ·annex-vii/3.4.1: 1 sentence (may) ·annex-vii/3.5.1: 1 sentence (shall) ·annex-vii/4.5.1: 1 sentence (shall) ·annex-vii/4.5.2: 1 sentence (shall) ·annex-vii/4.5.3: 2 sentences (shall) ·annex-vii/4.5.4: 5 sentences (shall) ·annex-vii/4.6: 1 sentence (shall) ·annex-vii/4.8: 1 sentence (shall) ·annex-vii/4.10: 1 sentence (shall) ·annex-vii/4.11: 2 sentences (shall) ·annex-ix/chapter-i/2.1: 1 sentence (shall) ·annex-ix/chapter-i/2.2: 1 sentence (shall) ·annex-ix/chapter-ii: 14 sentences (shall) ·annex-x/3: 6 sentences (shall) ·annex-x/5.2: 1 sentence (shall, may) ·annex-x/5.4: 1 sentence (shall) ·annex-x/5.5: 1 sentence (shall) ·annex-xiii/part-a/1: 4 sentences (shall) ·annex-xiii/part-a/1.1: 1 sentence (shall) ·annex-xiii/part-a/1.2: 1 sentence (shall) ·annex-xiii/part-a/1.2.1: 1 sentence (shall) ·annex-xiii/part-a/1.2.2: 3 sentences (shall) ·annex-xiii/part-a/1.2.3: 4 sentences (shall) ·annex-xiii/part-a/1.3.1: 1 sentence (shall) ·annex-xiii/part-a/1.3.2: 3 sentences (shall) ·annex-xiii/part-a/1.3.3: 3 sentences (shall) ·annex-xiii/part-a/2.1: 1 sentence (shall) ·annex-xiii/part-a/2.2: 1 sentence (shall) ·annex-xiii/part-a/2.3.1: 1 sentence (shall) ·annex-xiii/part-a/2.3.2: 4 sentences (shall) ·annex-xiii/part-a/2.3.3: 1 sentence (shall) ·annex-xiii/part-a/3: 1 sentence (shall) ·annex-xiii/part-b: 7 sentences (shall) ·annex-xiv/chapter-i: 1 sentence (shall) ·annex-xiv/chapter-i/1: 2 sentences (shall, may) ·annex-xiv/chapter-i/2: 1 sentence (shall) ·annex-xiv/chapter-ii/1: 1 sentence (may) ·annex-xiv/chapter-ii/3: 1 sentence (shall) ·annex-xiv/chapter-ii/4: 1 sentence (shall) - EU Machinery Regulation
EU5 sentences; text first observedno clause anchor before this sentence: 2 sentences (should, may) ·chapter-v/article-28/6: 1 sentence (shall) ·chapter-v/article-30/6: 1 sentence (shall) ·annex-iii/part-b/5: 1 sentence (shall) - EU MDR
EU121 sentences; text first observedno clause anchor before this sentence: 10 sentences (should) ·chapter-i/article-1/8: 1 sentence (shall) ·chapter-i/article-1/9: 1 sentence (shall) ·chapter-i/article-1/10: 1 sentence (shall) ·chapter-i/article-1/12: 1 sentence (shall) ·chapter-i/article-2: 1 sentence (shall, may) ·chapter-ii/article-5/2: 1 sentence (shall) ·chapter-ii/article-5/3: 1 sentence (shall) ·chapter-ii/article-5/5: 1 sentence (shall) ·chapter-ii/article-7: 1 sentence (shall, may) ·chapter-ii/article-9/1: 1 sentence (may) ·chapter-ii/article-9/3: 1 sentence (shall) ·chapter-ii/article-10/9: 1 sentence (shall) ·chapter-ii/article-13/5: 1 sentence (shall) ·chapter-ii/article-17/3: 1 sentence (may) ·chapter-ii/article-17/5: 1 sentence (shall) ·chapter-ii/article-23/1: 1 sentence (shall) ·chapter-ii/article-23/2: 1 sentence (shall) ·chapter-iii/article-32/1: 3 sentences (shall) ·chapter-iii/article-32/2: 1 sentence (shall) ·chapter-iii/article-32/3: 1 sentence (may) ·chapter-iv/article-35/6: 1 sentence (shall) ·chapter-iv/article-45/5: 1 sentence (may) ·chapter-v/section-2/article-55/1: 1 sentence (shall) ·chapter-v/section-2/article-55/3: 1 sentence (may) ·chapter-v/section-2/article-57/1: 1 sentence (shall) ·chapter-vi/article-61/1: 2 sentences (shall) ·chapter-vi/article-61/3: 1 sentence (shall) ·chapter-vi/article-61/4: 2 sentences (shall) ·chapter-vi/article-61/9: 1 sentence (shall) ·chapter-vi/article-61/10: 2 sentences (shall) ·chapter-vi/article-61/11: 1 sentence (shall) ·chapter-vi/article-62/1: 1 sentence (shall) ·chapter-vi/article-62/4: 1 sentence (may) ·chapter-vi/article-71/3: 1 sentence (shall) ·chapter-vi/article-71/4: 1 sentence (shall) ·chapter-vi/article-81: 1 sentence (may) ·chapter-vii/section-1/article-83/2: 1 sentence (shall) ·chapter-vii/section-1/article-83/3: 1 sentence (shall) ·chapter-vii/section-3/article-93/1: 1 sentence (shall) ·chapter-viii/article-101: 1 sentence (shall) ·chapter-viii/article-105: 1 sentence (shall) ·chapter-viii/article-106/1: 1 sentence (shall) ·chapter-viii/article-106/10: 1 sentence (may) ·chapter-viii/article-108: 1 sentence (shall) ·chapter-x/article-117: 2 sentences (shall) ·annex-i/chapter-i/1: 1 sentence (shall) ·annex-i/chapter-i/6: 1 sentence (shall) ·annex-i/chapter-i/7: 1 sentence (shall) ·annex-i/chapter-i/8: 1 sentence (shall) ·annex-i/chapter-ii: 9 sentences (shall) ·annex-i/chapter-iii: 4 sentences (shall, should, may) ·annex-ii/1.1: 1 sentence (shall) ·annex-ii/4: 2 sentences (shall) ·annex-ii/6: 1 sentence (shall) ·annex-ii/6.1: 1 sentence (shall) ·annex-ii/6.2: 1 sentence (shall) ·annex-iii: 1 sentence (shall) ·annex-vi/part-a/2.1: 1 sentence (may) ·annex-vi/part-c/4.10: 1 sentence (shall) ·annex-vi/part-c/6.5.2: 1 sentence (shall) ·annex-vii/1.1.4: 1 sentence (shall) ·annex-vii/1.1.5: 1 sentence (shall, may) ·annex-vii/1.1.6: 1 sentence (shall) ·annex-vii/1.3.1: 1 sentence (shall) ·annex-vii/3.1.1: 1 sentence (shall) ·annex-vii/3.2.5: 1 sentence (shall) ·annex-vii/3.4.1: 1 sentence (may) ·annex-vii/3.5.1: 1 sentence (shall) ·annex-vii/4.5.2: 1 sentence (shall) ·annex-vii/4.5.3: 1 sentence (shall) ·annex-vii/4.5.5: 2 sentences (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-ii: 4 sentences (shall) ·annex-x/3: 2 sentences (shall) ·annex-x/5.2: 1 sentence (shall, may) ·annex-xiii/1: 1 sentence (shall) ·annex-xiii/2: 1 sentence (shall) ·annex-xiv/part-a/1: 1 sentence (shall) ·annex-xiv/part-a/3: 2 sentences (shall) ·annex-xiv/part-a/4: 1 sentence (shall) ·annex-xiv/part-b: 2 sentences (shall) ·annex-xv/chapter-i/2.1: 1 sentence (shall) ·annex-xv/chapter-i/2.5: 1 sentence (shall) ·annex-xv/chapter-i/2.6: 1 sentence (shall) - EU NIS2 Directive
EU2 sentences; text first observedchapter-ii/article-7/4: 2 sentences (shall) - FDA AI guidance
US12 sentences; text first observed7: 12 sentences (should, may) - FDA device cybersecurity (2026)
US4 sentences; text first observed6: 4 sentences (may, should) - FDA electronic systems (clinical)
US1 sentence; text first observedno clause anchor before this sentence: 1 sentence (should) - FDA GMLP guiding principles
US1 sentence; text first observedno numbering read: 1 sentence (may) - ICH Q12
International6 sentences; text first observed4: 6 sentences (should, may) - ICH Q13
International9 sentences; text first observedfollows a withheld heading: 8 sentences (may, should) · id repeats in this text: 1 sentence (may) - ICH Q14
International28 sentences; text first observed13.2: 24 sentences (should, may) · id repeats in this text: 4 sentences (may, should) - ICH Q2(R2)
International11 sentences; text first observedannex-2/2.1: 2 sentences (should, may) ·annex-2/2.2: 1 sentence (should) ·annex-2/2.5: 1 sentence (should) ·annex-2/3: 2 sentences (may) ·annex-2/3.2.2.2: 1 sentence (should) ·annex-2/3.3.3: 1 sentence (may) ·annex-2/3.3.3.1: 1 sentence (should) ·annex-2/4: 1 sentence (should) · id repeats in this text: 1 sentence (may) - NIST AI 600-1
US6 sentences; text first observed6: 1 sentence (may) ·12: 5 sentences (may) - NIST AI RMF
International2 sentences; text first observed5.3: 1 sentence (should) ·6: 1 sentence (may) - 21 CFR Part 11
US1 sentence; text first observedno numbering read: 1 sentence (shall) - 21 CFR Part 211
US5 sentences; text first observedno numbering read: 5 sentences (shall, may) - 21 CFR Part 820 (QMSR)
US1 sentence; text first observedno numbering read: 1 sentence (shall)
In titles
0 tracked rows whose titles print one of the forms in the heading, read from the title this record holds, by the same exact rule.
No tracked row’s title prints it.
In body
319 occurrences in 31 current texts outside every sentence above and outside the term’s own definitions, each counted under the clause anchor the clause-anchor derivation placed last before it; each clause is followed by its count.
- Annex 15 revision concept paper
International1 occurrence; text first observed2: 1 - EU AI Act
EU8 occurrences; text first observedannex-iii/4: 1 ·annex-iv/2: 1 ·annex-iv/3: 1 ·annex-iv/4: 1 ·annex-iv/9: 1 · 3 where no heading is read before it - EU Cyber Resilience Act
EU2 occurrences; text first observed2 where no heading is read before it - EU Cybersecurity Act
EU1 occurrence; text first observed1 where no heading is read before it - Regulation (EU) 2026/1744
EU5 occurrences; text first observedarticle-1/3: 4 · 1 where no heading is read before it - EU GMP Annex 1
EU3 occurrences; text first observedannex-1/11: 3 - EU GMP Annex 11 (draft)
EU3 occurrences; text first observed17: 2 ·17.5: 1 - EU GMP Annex 12
EU1 occurrence; text first observed18: 1 - EU GMP Annex 15
EU3 occurrences; text first observed12: 3 - EU GMP Annex 16
EU1 occurrence; text first observed1 where no heading is read before it - EU GMP Annex 17
EU3 occurrences; text first observed5: 2 · 1 where no heading is read before it - EU GMP Annex 2
EU1 occurrence; text first observed36: 1 - EU GMP Annex 22
EU1 occurrence; text first observed10.3: 1 - EU GMP Chapter 2
EU1 occurrence; text first observedpart-1: 1 - EU IVDR
EU75 occurrences; text first observedannex-i/chapter-ii: 1 ·annex-ii/6.1: 1 ·annex-ii/6.1.2: 1 ·annex-ii/6.1.3: 1 ·annex-ii/6.2: 1 ·annex-xiii/part-a/1: 2 ·annex-xiii/part-a/1.2.2: 2 ·annex-xiii/part-a/1.3: 1 ·annex-xiii/part-a/2.1: 6 ·annex-xiii/part-a/2.3: 1 ·annex-xiv/chapter-i/2.3: 1 ·annex-xiv/chapter-i/2.4: 3 ·annex-xiv/chapter-i/2.6: 1 ·annex-xiv/chapter-i/2.7: 2 ·annex-xiv/chapter-i/2.8: 1 ·annex-xiv/chapter-i/4.1: 3 ·chapter-i/section-1/article-1/1: 1 ·chapter-i/section-1/article-2: 17 ·chapter-iii/article-29: 1 ·chapter-iv/article-41: 1 ·chapter-vi/article-57: 1 ·chapter-vi/article-58: 1 ·chapter-vi/article-58/2: 1 ·chapter-vi/article-66: 1 ·chapter-vi/article-67/3: 8 ·chapter-vi/article-68: 1 ·chapter-vi/article-69: 1 ·chapter-vi/article-71: 1 ·chapter-vi/article-72: 1 ·chapter-vi/article-73: 1 ·chapter-vi/article-74: 1 ·chapter-vi/article-76: 1 ·chapter-x/article-112: 1 ·chapter-x/article-113/3: 5 · 2 where no heading is read before it - EU Machinery Regulation
EU1 occurrence; text first observed1 where no heading is read before it - EU MDR
EU17 occurrences; text first observedannex-viii/chapter-iii: 6 ·annex-xv/chapter-ii/2.3: 1 ·annex-xv/chapter-ii/2.4: 3 ·annex-xv/chapter-ii/2.6: 1 ·annex-xv/chapter-ii/2.7: 2 ·annex-xv/chapter-ii/4.1: 1 ·annex-xv/chapter-iii/7: 1 ·chapter-iii/article-32: 1 ·chapter-x/article-123/3: 1 - FDA AI guidance
US13 occurrences; text first observed7: 13 - FDA device cybersecurity (2026)
US3 occurrences; text first observed6: 3 - FDA/EMA AI principles
International6 occurrences; text first observed6 where no numbering read in this text - ICH Q12
International7 occurrences; text first observed4: 7 - ICH Q13
International24 occurrences; text first observed24 where the heading before it is withheld - ICH Q14
International70 occurrences; text first observed13.2: 60 · 10 where the heading before it is withheld - ICH Q2(R2)
International24 occurrences; text first observedannex-2/2: 4 ·annex-2/2.1: 3 ·annex-2/2.2: 3 ·annex-2/2.5: 1 ·annex-2/3: 2 ·annex-2/3.3.3: 1 ·annex-2/4: 9 · 1 where no heading is read before it - ICH Q9(R1)
International6 occurrences; text first observed25: 5 ·8: 1 - NIST agent standards
US2 occurrences; text first observed2 where no numbering read in this text - NIST AI 600-1
US21 occurrences; text first observed12: 21 - NIST AI RMF
International6 occurrences; text first observed1.1: 1 ·3.1: 1 ·5.2: 1 ·5.3: 2 ·6: 1 - NIST SP 800-82
US3 occurrences; text first observed3 where no numbering read in this text - NISTIR 8183
US5 occurrences; text first observed7: 5 - 21 CFR Part 820 (QMSR)
US2 occurrences; text first observed2 where no numbering read in this text
Co-occurrence
232 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. 151 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 3 clauses:
eu-ivdrchapter-ii/article-5/5·chapter-x/article-113/3;eu-mdrchapter-x/article-123/3 - Act 3 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124 - active device 2 clauses:
eu-mdrannex-viii/chapter-iii·chapter-i/article-2 - adverse event 7 clauses:
ema-data-quality-framework10;eu-gmp-annex-236;eu-ivdrchapter-i/section-1/article-2·chapter-vi/article-76/1·chapter-vi/article-76/2·chapter-vi/article-76/6;eu-mdrchapter-i/article-2 - Agency 6 clauses:
ema-data-quality-framework10;eu-mdrchapter-x/article-123/3;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·chapter-x/article-95/2;eu-digital-omnibus-aiarticle-1/3 - AI Office 6 clauses:
eu-ai-actchapter-i/article-3·chapter-v/section-4/article-56/4·chapter-v/section-4/article-56/5·chapter-vii/section-1/article-68/5·chapter-x/article-95/2;eu-digital-omnibus-aiarticle-1/6 - AI regulatory sandbox 2 clauses:
eu-ai-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/6 - AI system 18 clauses:
eu-ai-actannex-iv/2·annex-iv/3·annex-iv/4·annex-iv/9·chapter-i/article-3·chapter-iii/section-2/article-13/3·chapter-iii/section-2/article-14/4·chapter-iii/section-4/article-31/8·chapter-iii/section-5/article-40/2·chapter-iii/section-5/article-43/4;eu-digital-omnibus-aiarticle-1/3·article-1/6;eu-gmp-annex-2210.5;nist-ai-600-112;nist-ai-rmf3.1·5.2·5.3·6 - allow-list 1 clause:
fda-device-cybersecurity-20266 - analytical performance 14 clauses:
eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii·annex-ii/6.1·annex-ii/6.1.3·annex-xiii/part-a/1·annex-xiii/part-a/1.2.2·annex-xiii/part-a/1.3.2·annex-xiii/part-a/2.1·annex-xiii/part-a/2.3.2·chapter-i/section-1/article-2·chapter-vi/article-56/3·chapter-vi/article-56/5·chapter-vi/article-58/5·chapter-vi/article-67/3 - Application 9 clauses:
eu-gmp-annex-11-draft17.5;eu-ivdrannex-xiv/chapter-i/1·chapter-vi/article-66;eu-machinery-regulationannex-iii/part-b/5;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;nist-ai-rmf6;nistir-81837 - assurance level 1 clause:
eu-gmp-annex-1annex-1/11 - Audits 1 clause:
eu-gmp-chapter-5part-1 - authorised representative 12 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-2/article-13/3;eu-ivdrannex-i/chapter-iii·annex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-xiv/chapter-i/1·chapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-i/chapter-iii·annex-ix/chapter-i/2.2·annex-xiii/1·chapter-i/article-2 - Autonomous mobile machinery 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - benefit-risk determination 6 clauses:
eu-ivdrannex-ix/chapter-ii·chapter-i/section-1/article-2·chapter-vii/section-1/article-78/3;eu-mdrannex-ix/chapter-ii·chapter-i/article-2·chapter-vii/section-1/article-83/3 - biometric categorisation system 1 clause:
eu-ai-actchapter-i/article-3 - biometric data 1 clause:
eu-ai-actchapter-i/article-3 - biometric identification 1 clause:
eu-ai-actchapter-i/article-3 - 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 12 clauses:
eu-ai-actchapter-i/article-3;eu-ivdrannex-xiii/part-b·chapter-i/section-1/article-2·chapter-ii/article-10/5·chapter-ii/article-18/1·chapter-vi/article-70/1·chapter-vi/article-70/2·chapter-x/article-113/3;eu-mdrannex-xiv/part-b·chapter-i/article-2·chapter-x/article-117·chapter-x/article-123/3 - CE marking of conformity 6 clauses:
eu-ivdrchapter-i/section-1/article-2·chapter-ii/article-10/5·chapter-ii/article-18/1·chapter-x/article-113/3;eu-mdrchapter-i/article-2·chapter-x/article-123/3 - chains 6 clauses:
eu-gmp-annex-236;eu-machinery-regulationannex-iii/part-b/5;ich-q124;ich-q9r125·8;nist-ai-600-112 - clinical benefit 9 clauses:
eu-ivdrannex-xiii/part-a/1.3.1·chapter-i/section-1/article-2·chapter-vi/article-56/3;eu-mdrannex-i/chapter-ii·annex-i/chapter-iii·annex-xv/chapter-ii/2.4·annex-xv/chapter-ii/2.6·chapter-i/article-2·chapter-vi/article-61/9 - clinical data 20 clauses:
eu-ivdrannex-vii/3.2.4·annex-vii/4.10·annex-vii/4.11·annex-xiv/chapter-i/2.4·chapter-i/section-1/article-2;eu-mdrannex-ii/6.1·annex-ix/chapter-ii·annex-vii/4.10·annex-vii/4.11·annex-vii/4.5.5·annex-xiv/part-a/1·annex-xiv/part-a/3·annex-xiv/part-a/4·annex-xiv/part-b·annex-xv/chapter-ii/2.4·chapter-i/article-2·chapter-vi/article-61/1·chapter-vi/article-61/10·chapter-vi/article-61/11·chapter-vi/article-61/9 - clinical evaluation 32 clauses:
eu-ivdrannex-ix/chapter-i/2.2;eu-mdrannex-ii/6.1·annex-ix/chapter-i/2.2·annex-ix/chapter-ii·annex-vii/3.2.5·annex-vii/4.10·annex-vii/4.11·annex-vii/4.5.3·annex-vii/4.5.5·annex-x/3·annex-xiv/part-a/1·annex-xiv/part-a/3·annex-xiv/part-a/4·annex-xiv/part-b·annex-xv/chapter-ii/2.3·chapter-i/article-2·chapter-ii/article-10/9·chapter-ii/article-5/3·chapter-ii/article-9/1·chapter-iii/article-32/2·chapter-iv/article-45/5·chapter-vi/article-61/1·chapter-vi/article-61/10·chapter-vi/article-61/11·chapter-vi/article-61/3·chapter-vi/article-61/4·chapter-vi/article-62/1·chapter-vi/article-62/4·chapter-vi/article-71/3·chapter-vii/section-1/article-83/3·chapter-viii/article-106/1·chapter-viii/article-106/10 - clinical evidence 25 clauses:
eu-ivdrannex-ii/6.2·annex-ix/chapter-ii·annex-vii/4.5.4·annex-x/3·annex-xiii/part-a/1·annex-xiii/part-a/1.3.1·annex-xiii/part-a/1.3.2·annex-xiii/part-a/1.3.3·annex-xiii/part-a/2.1·annex-xiii/part-b·chapter-i/section-1/article-2·chapter-ii/article-8/1·chapter-vi/article-56/1·chapter-vi/article-56/2·chapter-vi/article-56/3·chapter-vi/article-56/5·chapter-vi/article-77;eu-mdrannex-ix/chapter-ii·annex-vii/4.5.5·annex-x/3·annex-xiv/part-a/1·annex-xiv/part-a/4·chapter-i/article-2·chapter-vi/article-61/1·chapter-vi/article-81 - clinical investigation 14 clauses:
eu-mdrannex-i/chapter-iii·annex-vi/part-a/2.1·annex-vii/4.5.5·annex-xv/chapter-i/2.6·annex-xv/chapter-ii/4.1·annex-xv/chapter-iii/7·chapter-i/article-2·chapter-ii/article-9/1·chapter-vi/article-61/9·chapter-vi/article-62/4·chapter-vi/article-71/3·chapter-vi/article-71/4·chapter-viii/article-105;fda-ai-guidance7 - clinical investigation plan 4 clauses:
eu-mdrannex-vii/4.5.5·annex-xv/chapter-iii/7·chapter-i/article-2·chapter-vi/article-62/4 - clinical performance 51 clauses:
eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii·annex-ii/6.2·annex-xiii/part-a/1·annex-xiii/part-a/1.1·annex-xiii/part-a/1.2·annex-xiii/part-a/1.2.1·annex-xiii/part-a/1.2.2·annex-xiii/part-a/1.2.3·annex-xiii/part-a/1.3.1·annex-xiii/part-a/1.3.2·annex-xiii/part-a/2.1·annex-xiii/part-a/2.2·annex-xiii/part-a/2.3·annex-xiii/part-a/2.3.2·annex-xiii/part-a/2.3.3·annex-xiii/part-a/3·annex-xiii/part-b·annex-xiv/chapter-i·annex-xiv/chapter-i/1·annex-xiv/chapter-i/2.4·annex-xiv/chapter-i/4.1·annex-xiv/chapter-ii/3·annex-xiv/chapter-ii/4·chapter-i/section-1/article-2·chapter-ii/article-15/3·chapter-vi/article-56/1·chapter-vi/article-56/3·chapter-vi/article-56/4·chapter-vi/article-56/5·chapter-vi/article-58/1·chapter-vi/article-58/5·chapter-vi/article-64/1·chapter-vi/article-67/3·chapter-vi/article-73/5·chapter-vi/article-76/3·chapter-x/article-113/3;eu-mdrannex-i/chapter-iii·annex-vi/part-a/2.1·annex-xiv/part-a/1·annex-xiv/part-a/3·chapter-i/article-2·chapter-iii/article-32·chapter-iii/article-32/1·chapter-iii/article-32/2·chapter-iii/article-32/3·chapter-v/section-2/article-55/1·chapter-v/section-2/article-57/1·chapter-vi/article-61/10·chapter-vi/article-61/11·chapter-vii/section-1/article-83/3 - Closed system 2 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-236 - common specification 1 clause:
eu-ai-actchapter-i/article-3 - companion diagnostic 4 clauses:
eu-ivdrannex-i/chapter-iii·annex-ix/chapter-ii·annex-x/5.5·chapter-i/section-1/article-2 - Component / component 17 clauses:
eu-ai-actchapter-i/article-3;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17.5;eu-gmp-annex-236;eu-ivdrannex-vii/3.4.1·chapter-ii/article-20/1·chapter-ii/article-20/2;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-i/chapter-ii·annex-vii/3.4.1·chapter-ii/article-23/1·chapter-ii/article-23/2;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18;nist-ai-600-112;nistir-81837 - conformity assessment 70 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-2/article-13/3·chapter-iii/section-4/article-31/3·chapter-iii/section-4/article-31/7·chapter-iii/section-5/article-43/4;eu-cyber-resilience-actchapter-iv/article-39/6;eu-cybersecurity-acttitle-iii/article-58/8·title-iv/article-69/10;eu-digital-omnibus-aiarticle-1/3·article-1/6;eu-ivdrannex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-ix/chapter-ii·annex-vii/1.1.4·annex-vii/1.1.5·annex-vii/1.1.6·annex-vii/1.3.1·annex-vii/3.1.1·annex-vii/3.2.1·annex-vii/3.2.4·annex-vii/3.2.5·annex-vii/3.4.1·annex-vii/3.5.1·annex-vii/4.5.1·annex-vii/4.5.2·annex-vii/4.5.3·annex-vii/4.5.4·annex-vii/4.6·annex-xiii/part-b·chapter-i/section-1/article-2·chapter-ii/article-10/5·chapter-ii/article-10/8·chapter-ii/article-7·chapter-iii/article-29/1·chapter-v/section-2/article-48/3·chapter-v/section-2/article-48/4·chapter-v/section-2/article-48/5·chapter-v/section-2/article-48/7·chapter-v/section-2/article-48/8·chapter-v/section-2/article-48/9·chapter-vi/article-69/3·chapter-viii/article-100/2·chapter-viii/article-99;eu-machinery-regulationannex-iii/part-b/5·chapter-v/article-30/6;eu-mdrannex-i/chapter-ii·annex-ix/chapter-i/2.2·annex-ix/chapter-ii·annex-vii/1.1.4·annex-vii/1.1.5·annex-vii/1.1.6·annex-vii/1.3.1·annex-vii/3.1.1·annex-vii/3.2.5·annex-vii/3.4.1·annex-vii/3.5.1·annex-vii/4.5.2·annex-vii/4.5.3·annex-vii/4.5.5·annex-xiv/part-b·chapter-i/article-2·chapter-ii/article-10/9·chapter-ii/article-7·chapter-iii/article-32/1·chapter-v/section-2/article-55/1·chapter-vi/article-62/1·chapter-viii/article-105·chapter-viii/article-106/10·chapter-x/article-117;nist-ai-600-112 - conformity assessment body 6 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-iv/article-39/6;eu-cybersecurity-acttitle-iv/article-69/10;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-v/article-30/6;eu-mdrchapter-i/article-2 - consumer 2 clauses:
nist-ai-600-112;nistir-81837 - control material 1 clause:
eu-ivdrchapter-i/section-1/article-2 - corrective action 12 clauses:
eu-gmp-annex-1annex-1/11;eu-ivdrannex-vii/4.10·chapter-i/section-1/article-2·chapter-vii/section-1/article-78/3·chapter-vii/section-2/article-82/1;eu-mdrannex-vi/part-a/2.1·annex-vii/4.10·chapter-i/article-2·chapter-vii/section-1/article-83/3;fda-device-cybersecurity-20266;ich-q124;ich-q9r125 - critical infrastructure 3 clauses:
eu-ai-actchapter-i/article-3;nist-ai-600-112;nistir-81837 - custom-made device 2 clauses:
eu-mdrannex-i/chapter-iii·chapter-i/article-2 - cyber threat 1 clause:
fda-device-cybersecurity-20266 - cybersecurity 10 clauses:
eu-ai-actannex-iv/2·chapter-iii/section-2/article-13/3·chapter-iii/section-2/article-15/5;eu-cybersecurity-acttitle-iii/article-58/8;eu-nis2chapter-ii/article-7/4;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-600-112;nist-ai-rmf6;nistir-81837 - cybersecurity risk 5 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-600-112;nist-ai-rmf6;nistir-81837 - danger zone 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - deep fake 1 clause:
eu-ai-actchapter-i/article-3 - deployer 5 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-2/article-14/4·chapter-iii/section-5/article-43/4;eu-digital-omnibus-aiarticle-1/3·article-1/6 - derivative 5 clauses:
eu-mdrannex-i/chapter-iii·annex-ix/chapter-ii·annex-xiii/1·annex-xv/chapter-ii/2.6·chapter-i/article-2 - device deficiency 4 clauses:
eu-ivdrchapter-i/section-1/article-2·chapter-vi/article-76/1·chapter-vi/article-76/2;eu-mdrchapter-i/article-2 - device for near-patient testing 1 clause:
eu-ivdrchapter-i/section-1/article-2 - device for performance study 8 clauses:
eu-ivdrannex-i/chapter-iii·annex-xiv/chapter-i/1·annex-xiv/chapter-i/2·annex-xiv/chapter-i/4.1·chapter-i/section-1/article-2·chapter-iii/article-24/3·chapter-vi/article-57/1·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 4 clauses:
eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii·chapter-i/section-1/article-2·chapter-v/section-2/article-48/5 - diagnostic specificity 3 clauses:
eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii·chapter-i/section-1/article-2 - distributor 3 clauses:
eu-ai-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - 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 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - Electronic record 1 clause:
eu-gmp-annex-11-draft17.5 - emotion recognition system 1 clause:
eu-ai-actchapter-i/article-3 - end-to-end 1 clause:
fda-device-cybersecurity-20266 - entity 12 clauses:
ema-data-quality-framework10;eu-ai-actchapter-i/article-3;eu-gmp-annex-236;eu-gmp-chapter-5part-1;eu-ivdrchapter-ii/article-5/5·chapter-iii/article-24/3·chapter-vi/article-58/5;eu-mdrchapter-ii/article-5/5·chapter-vi/article-62/4;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18 - essential health and safety requirements 3 clauses:
eu-ivdrchapter-i/section-1/article-1/6;eu-machinery-regulationannex-iii/part-b/5;eu-mdrchapter-i/article-1/12 - ethics committee 9 clauses:
eu-ivdrannex-xiv/chapter-i/1·chapter-i/section-1/article-2·chapter-vi/article-58/3·chapter-vi/article-58/5·chapter-vi/article-66/7·chapter-vi/article-71/3·chapter-vi/article-74/10;eu-mdrchapter-i/article-2·chapter-vi/article-62/4 - European cybersecurity certification scheme 1 clause:
eu-cybersecurity-acttitle-iii/article-58/8 - European standard 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - falsified device 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - Federal Food, Drug, and Cosmetic Act 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - field safety corrective action 6 clauses:
eu-ivdrchapter-i/section-1/article-2·chapter-vii/section-1/article-78/3·chapter-vii/section-2/article-82/1;eu-mdrannex-vi/part-a/2.1·chapter-i/article-2·chapter-vii/section-1/article-83/3 - field safety notice 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - floating-point operation 1 clause:
eu-ai-actchapter-i/article-3 - fully refurbishing 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - general-purpose AI model 1 clause:
eu-ai-actchapter-i/article-3 - general-purpose AI system 1 clause:
eu-ai-actchapter-i/article-3 - generic device group 3 clauses:
eu-ivdrchapter-i/section-1/article-2·chapter-v/section-2/article-48/7;eu-mdrchapter-i/article-2 - guard 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - Guided load 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - hardware 13 clauses:
eu-ai-actchapter-iii/section-2/article-13/3;eu-gmp-annex-11-draft17·17.5;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·annex-ii/6.1;fda-device-cybersecurity-20266;ich-q9r125;nist-ai-600-112;nistir-81837 - Harm 2 clauses:
fda-device-cybersecurity-20266;nist-ai-600-112 - harmonised standard 6 clauses:
eu-ai-actchapter-i/article-3;eu-ivdrannex-ii/4·chapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-ii/4·chapter-i/article-2 - Hazard / hazard 8 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-chapter-2part-1;eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-1/6;eu-machinery-regulationannex-iii/part-b/5;eu-mdrchapter-i/article-1/12;ich-q9r125·8 - Hazard Identification 1 clause:
ich-q9r18 - health institution 6 clauses:
eu-ivdrchapter-i/section-1/article-2·chapter-ii/article-5/5;eu-mdrannex-xiii/1·chapter-i/article-2·chapter-ii/article-17/3·chapter-ii/article-5/5 - high-impact capabilities 1 clause:
eu-ai-actchapter-i/article-3 - ICT process 1 clause:
eu-cybersecurity-acttitle-iv/article-69/10 - ICT product 1 clause:
eu-cybersecurity-acttitle-iv/article-69/10 - ICT service 1 clause:
eu-cybersecurity-acttitle-iv/article-69/10 - identity management 1 clause:
fda-device-cybersecurity-20266 - implantable device 1 clause:
eu-mdrchapter-i/article-2 - importer 4 clauses:
eu-ai-actchapter-i/article-3;eu-gmp-chapter-5part-1;eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - in vitro diagnostic medical device 2 clauses:
eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2 - incident 13 clauses:
eu-ai-actchapter-i/article-3;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-82/1;eu-mdrannex-i/chapter-iii·chapter-i/article-2;fda-device-cybersecurity-20266;nist-ai-600-112;nist-ai-rmf5.2;nistir-81837 - incident handling 1 clause:
nistir-81837 - informed consent 15 clauses:
eu-ai-actchapter-i/article-3;eu-ivdrannex-xiii/part-a/2.3.2·chapter-i/section-1/article-2·chapter-vi/article-58/5·chapter-vi/article-58/6·chapter-vi/article-59/2·chapter-vi/article-59/7·chapter-vi/article-60/1·chapter-vi/article-61/1·chapter-vi/article-64/1·chapter-vi/article-64/2;eu-mdrchapter-i/article-2·chapter-vi/article-62/4;fda-device-cybersecurity-20266;nist-ai-600-112 - input data 8 clauses:
eu-ai-actannex-iv/3·chapter-i/article-3·chapter-iii/section-2/article-13/3;eu-gmp-annex-2210.5;ich-q1413.2;ich-q2r2annex-2/2.5·annex-2/4;nist-ai-600-112 - instructions for use 24 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-2/article-13/3;eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii·annex-ix/chapter-ii·annex-vii/4.10·annex-x/3·annex-xiii/part-a/2.3.2·chapter-i/section-1/article-2·chapter-ii/article-7·chapter-iii/article-29/1·chapter-v/section-2/article-50/1·chapter-vii/section-1/article-78/3;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-i/chapter-ii·annex-i/chapter-iii·annex-ix/chapter-ii·annex-vii/4.10·chapter-i/article-2·chapter-ii/article-7·chapter-iii/article-32/1·chapter-v/section-2/article-55/1·chapter-vii/section-1/article-83/3·chapter-x/article-123/3 - intended purpose 61 clauses:
eu-ai-actannex-iv/3·chapter-i/article-3·chapter-iii/section-2/article-13/3;eu-digital-omnibus-aiarticle-1/3;eu-gmp-annex-1512;eu-ivdrannex-i/chapter-i/1·annex-i/chapter-ii·annex-i/chapter-iii·annex-ii/4·annex-ix/chapter-ii·annex-x/5.2·annex-xiii/part-a/1·annex-xiii/part-a/1.1·annex-xiii/part-a/1.2·annex-xiii/part-a/1.3.2·annex-xiii/part-a/2.3.2·annex-xiii/part-b·annex-xiv/chapter-i/2.4·chapter-i/section-1/article-2·chapter-ii/article-20/1·chapter-ii/article-20/2·chapter-ii/article-5/2·chapter-ii/article-5/5·chapter-ii/article-7·chapter-iii/article-29/2·chapter-vi/article-56/1·chapter-vi/article-56/2·chapter-vi/article-58/5·chapter-vi/article-70/1·chapter-vi/article-70/2;eu-mdrannex-i/chapter-i/1·annex-i/chapter-ii·annex-i/chapter-iii·annex-ii/1.1·annex-ii/4·annex-ii/6.1·annex-ii/6.2·annex-ix/chapter-ii·annex-vi/part-a/2.1·annex-viii/chapter-iii·annex-x/5.2·annex-xiv/part-a/1·annex-xiv/part-a/3·annex-xiv/part-b·annex-xv/chapter-i/2.6·annex-xv/chapter-ii/2.4·annex-xv/chapter-iii/7·chapter-i/article-2·chapter-ii/article-23/1·chapter-ii/article-23/2·chapter-ii/article-5/2·chapter-ii/article-5/5·chapter-ii/article-7·chapter-iii/article-32/2·chapter-vi/article-61/1·chapter-vi/article-61/3;ich-q1413.2;ich-q2r2annex-2/2·annex-2/2.1·annex-2/4;nist-ai-600-112 - intended use 30 clauses:
ema-data-quality-framework10;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-236;eu-gmp-annex-2210;eu-gmp-chapter-1chapter-1;eu-gmp-chapter-6part-1;eu-ivdrannex-i/chapter-i/7·annex-i/chapter-ii·annex-ix/chapter-ii·annex-vi/part-c/6.2.2·annex-vii/4.5.2·annex-vii/4.5.4·annex-x/5.5·annex-xiii/part-a/1.1·chapter-vi/article-56/1;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-i/chapter-i/7·annex-i/chapter-ii·annex-vi/part-c/6.5.2·annex-vii/4.5.2·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-rmf3.1·5.2 - interchangeable equipment 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - international standard 1 clause:
eu-gmp-annex-1annex-1/11 - interventional clinical performance study 2 clauses:
eu-ivdrchapter-i/section-1/article-2·chapter-vi/article-58/1 - invasive device 1 clause:
eu-mdrchapter-i/article-2 - investigational device 5 clauses:
eu-mdrannex-xv/chapter-ii/4.1·annex-xv/chapter-iii/7·chapter-i/article-2·chapter-vi/article-62/4·chapter-vi/article-71/3 - investigator 15 clauses:
eu-ivdrannex-xiii/part-a/2.3.2·annex-xiv/chapter-i/1·annex-xiv/chapter-i/2·chapter-i/section-1/article-2·chapter-vi/article-58/7·chapter-vi/article-60/1·chapter-vi/article-61/1·chapter-vi/article-64/1·chapter-vi/article-64/2·chapter-vi/article-65/2·chapter-vi/article-67/4·chapter-vi/article-68/1·chapter-vi/article-68/3;eu-mdrchapter-i/article-2·chapter-vi/article-71/4 - kit 2 clauses:
eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2 - label 16 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·chapter-i/section-1/article-2·chapter-iii/article-24/1·chapter-iii/article-29/1;eu-mdrannex-i/chapter-ii·annex-i/chapter-iii·annex-xiv/part-b·chapter-i/article-2·chapter-iii/article-32/1;ich-q9r125;nist-ai-600-112 - law enforcement 2 clauses:
eu-ai-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/6 - law enforcement authority 1 clause:
eu-ai-actchapter-i/article-3 - lay person 4 clauses:
eu-ivdrchapter-i/section-1/article-2·chapter-vi/article-58/3;eu-mdrannex-i/chapter-ii·chapter-i/article-2 - lifetime 16 clauses:
eu-ai-actchapter-iii/section-2/article-13/3·chapter-ix/section-1/article-72/2;eu-ivdrannex-i/chapter-i/6·annex-i/chapter-ii·annex-i/chapter-iii·annex-xiii/part-b·chapter-i/section-1/article-2·chapter-vii/section-1/article-78/2;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-i/chapter-i/6·annex-i/chapter-iii·annex-vi/part-c/4.10·annex-xiv/part-b·chapter-i/article-2·chapter-vii/section-1/article-83/2;nist-ai-rmf3.1 - lifting accessory 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - 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 - machinery 6 clauses:
eu-ivdrchapter-i/section-1/article-1/6·chapter-x/article-113/3;eu-machinery-regulationannex-iii/part-b/5·chapter-v/article-30/6;eu-mdrchapter-i/article-1/12·chapter-x/article-123/3 - Machinery or related products for plant protection products application 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - Machinery or related products presenting risks due to their mobility 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - making available on the market 5 clauses:
eu-ai-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-1/1·chapter-i/section-1/article-2;eu-mdrannex-i/chapter-iii·chapter-i/article-2 - manufacturer 107 clauses:
eu-ai-actchapter-i/article-3;eu-gmp-annex-1annex-1/11;eu-gmp-annex-1512;eu-gmp-annex-175;eu-gmp-annex-236;eu-gmp-annex-215.4;eu-gmp-chapter-1chapter-1;eu-gmp-chapter-2part-1;eu-gmp-chapter-5part-1;eu-gmp-chapter-6part-1;eu-ivdrannex-i/chapter-i/1·annex-i/chapter-i/6·annex-i/chapter-i/7·annex-i/chapter-ii·annex-i/chapter-iii·annex-ii/6.5·annex-iii/1·annex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-ix/chapter-ii·annex-vii/3.2.4·annex-vii/4.10·annex-vii/4.11·annex-vii/4.5.1·annex-vii/4.5.2·annex-vii/4.5.3·annex-vii/4.5.4·annex-vii/4.6·annex-vii/4.8·annex-x/3·annex-x/5.2·annex-x/5.4·annex-xiii/part-a/1·annex-xiii/part-a/1.2·annex-xiii/part-a/1.2.1·annex-xiii/part-a/1.2.2·annex-xiii/part-a/1.2.3·annex-xiii/part-a/1.3.1·annex-xiii/part-a/1.3.3·annex-xiii/part-a/2.3.2·annex-xiii/part-b·annex-xiv/chapter-i/1·chapter-i/section-1/article-2·chapter-ii/article-10/8·chapter-ii/article-13/5·chapter-iii/article-24/1·chapter-iii/article-24/3·chapter-iii/article-29/1·chapter-iii/article-29/2·chapter-iv/article-41/1·chapter-iv/article-41/3·chapter-v/section-2/article-48/10·chapter-v/section-2/article-48/3·chapter-v/section-2/article-48/5·chapter-v/section-2/article-48/6·chapter-v/section-2/article-48/7·chapter-v/section-2/article-48/9·chapter-vi/article-56/1·chapter-vi/article-56/2·chapter-vi/article-56/6·chapter-vi/article-57/1·chapter-vii/section-1/article-78/3·chapter-vii/section-2/article-83/1·chapter-viii/article-100/2·chapter-viii/article-100/3;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-i/chapter-i/1·annex-i/chapter-i/6·annex-i/chapter-i/7·annex-i/chapter-ii·annex-i/chapter-iii·annex-ii/1.1·annex-ii/6.1·annex-ii/6.2·annex-iii·annex-ix/chapter-i/2.2·annex-ix/chapter-ii·annex-vii/4.10·annex-vii/4.11·annex-vii/4.5.2·annex-vii/4.5.3·annex-vii/4.5.5·annex-x/3·annex-x/5.2·annex-xiii/1·annex-xiii/2·annex-xiv/part-a/4·annex-xiv/part-b·annex-xv/chapter-i/2.1·annex-xv/chapter-ii/2.4·chapter-i/article-2·chapter-ii/article-10/9·chapter-ii/article-13/5·chapter-iii/article-32/1·chapter-iii/article-32/2·chapter-vi/article-61/1·chapter-vi/article-61/10·chapter-vi/article-61/11·chapter-vi/article-61/4·chapter-vi/article-62/1·chapter-vi/article-71/3·chapter-vii/section-1/article-83/3·chapter-x/article-117;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;nistir-81837 - market surveillance 42 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-v/article-60/3;eu-digital-omnibus-aiarticle-1/6;eu-ivdrannex-iii/1·annex-ix/chapter-i/2.1·annex-ix/chapter-ii·annex-vii/4.10·annex-vii/4.11·annex-vii/4.5.2·annex-vii/4.5.4·annex-vii/4.8·annex-xiii/part-a/1.3.3·annex-xiii/part-b·chapter-i/section-1/article-2·chapter-ii/article-10/8·chapter-ii/article-15/3·chapter-ii/article-8/1·chapter-iii/article-30/2·chapter-iv/article-41/5·chapter-vi/article-56/6·chapter-vii/section-1/article-78/2·chapter-vii/section-1/article-78/3·chapter-vii/section-2/article-83/1·chapter-viii/article-100/2·chapter-viii/article-99·chapter-x/article-113/3;eu-mdrannex-iii·annex-ix/chapter-ii·annex-vii/4.10·annex-vii/4.11·annex-vii/4.5.2·annex-vii/4.5.5·annex-xiv/part-b·chapter-i/article-2·chapter-ii/article-10/9·chapter-iv/article-45/5·chapter-vi/article-61/11·chapter-vi/article-61/9·chapter-vii/section-1/article-83/2·chapter-vii/section-1/article-83/3·chapter-viii/article-105·chapter-x/article-123/3 - market surveillance authority 2 clauses:
eu-ai-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/6 - medical device 8 clauses:
eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2;eu-mdrannex-i/chapter-iii·chapter-i/article-2·chapter-vi/article-61/9·chapter-x/article-117;fda-ai-guidance7;fda-device-cybersecurity-20266 - Metadata 2 clauses:
ema-data-quality-framework10;nist-ai-600-112 - nanomaterial 3 clauses:
eu-mdrannex-viii/chapter-iii·chapter-i/article-2·chapter-x/article-123/3 - national competent authority 5 clauses:
eu-ai-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/6;eu-gmp-annex-236;eu-ivdrchapter-iv/article-31/6;eu-mdrchapter-iv/article-35/6 - national cybersecurity strategy 1 clause:
eu-nis2chapter-ii/article-7/4 - negative predictive value 3 clauses:
eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii·chapter-i/section-1/article-2 - non-personal data 1 clause:
eu-ai-actchapter-i/article-3 - non-viable 8 clauses:
eu-gmp-annex-1annex-1/11;eu-mdrannex-i/chapter-ii·annex-ix/chapter-ii·annex-viii/chapter-iii·annex-xiv/part-a/1·annex-xv/chapter-ii/2.6·chapter-i/article-1/10·chapter-i/article-2 - notified body 71 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-iv/article-39/6;eu-digital-omnibus-aiarticle-1/6;eu-ivdrannex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-ix/chapter-ii·annex-vi/part-a/2.1·annex-vii/1.1.4·annex-vii/1.1.5·annex-vii/1.1.6·annex-vii/1.3.1·annex-vii/3.1.1·annex-vii/3.2.1·annex-vii/3.2.2·annex-vii/3.2.4·annex-vii/3.4.1·annex-vii/3.5.1·annex-vii/4.10·annex-vii/4.11·annex-vii/4.5.1·annex-vii/4.5.2·annex-vii/4.5.3·annex-vii/4.5.4·annex-vii/4.6·annex-vii/4.8·annex-x/3·annex-x/5.2·annex-x/5.4·annex-x/5.5·annex-xiv/chapter-i/1·chapter-i/section-1/article-2·chapter-iii/article-29/1·chapter-iv/article-41·chapter-iv/article-41/1·chapter-iv/article-41/3·chapter-iv/article-41/5·chapter-v/section-2/article-48/10·chapter-v/section-2/article-48/3·chapter-v/section-2/article-48/4·chapter-v/section-2/article-48/5·chapter-v/section-2/article-48/6·chapter-v/section-2/article-48/7·chapter-v/section-2/article-48/8·chapter-v/section-2/article-50/1·chapter-x/article-113/3;eu-machinery-regulationchapter-v/article-30/6;eu-mdrannex-ix/chapter-i/2.2·annex-ix/chapter-ii·annex-vi/part-a/2.1·annex-vii/1.1.4·annex-vii/1.1.5·annex-vii/1.1.6·annex-vii/1.3.1·annex-vii/3.1.1·annex-vii/3.4.1·annex-vii/3.5.1·annex-vii/4.10·annex-vii/4.11·annex-vii/4.5.2·annex-vii/4.5.3·annex-vii/4.5.5·annex-x/3·annex-x/5.2·chapter-i/article-2·chapter-ii/article-17/5·chapter-iii/article-32/1·chapter-iv/article-45/5·chapter-v/section-2/article-55/1·chapter-vi/article-61/4·chapter-x/article-117·chapter-x/article-123/3 - notifying authority 3 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-iv/article-37/6;eu-machinery-regulationchapter-v/article-28/6 - online search engine 1 clause:
eu-digital-omnibus-aiarticle-1/6 - operator 15 clauses:
eu-ai-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/6;eu-gmp-annex-1annex-1/11;eu-gmp-annex-236;eu-gmp-annex-2210·10.5;eu-gmp-chapter-2part-1;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5;eu-mdrchapter-i/article-2;fda-device-cybersecurity-20266;nist-ai-600-112;nist-ai-rmf5.2·6;nistir-81837 - particle 5 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-1512;eu-mdrchapter-i/article-2;ich-q1413.2;ich-q9r125 - partly completed machinery 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - performance evaluation 47 clauses:
eu-ivdrannex-ii/6.2·annex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-ix/chapter-ii·annex-vii/3.2.1·annex-vii/3.2.2·annex-vii/3.2.4·annex-vii/3.2.5·annex-vii/4.10·annex-vii/4.11·annex-vii/4.5.1·annex-vii/4.5.2·annex-vii/4.5.3·annex-vii/4.5.4·annex-vii/4.6·annex-vii/4.8·annex-x/3·annex-xiii/part-a/1·annex-xiii/part-a/1.1·annex-xiii/part-a/1.3·annex-xiii/part-a/1.3.2·annex-xiii/part-a/1.3.3·annex-xiii/part-a/2.1·annex-xiii/part-b·annex-xiv/chapter-i/1·chapter-i/section-1/article-2·chapter-ii/article-10/3·chapter-ii/article-10/8·chapter-ii/article-5/3·chapter-ii/article-9/1·chapter-iii/article-29/2·chapter-iv/article-40/8·chapter-iv/article-41·chapter-iv/article-41/1·chapter-iv/article-41/3·chapter-iv/article-41/5·chapter-iv/article-41/6·chapter-v/section-2/article-48/6·chapter-vi/article-56/1·chapter-vi/article-56/2·chapter-vi/article-56/3·chapter-vi/article-56/5·chapter-vi/article-56/6·chapter-vii/section-1/article-78/3;eu-mdrchapter-vi/article-61/10·chapter-viii/article-106/1·chapter-viii/article-106/10 - performance of a device 5 clauses:
eu-ivdrannex-i/chapter-i/6·annex-xiii/part-a/1.2.3·chapter-i/section-1/article-2;eu-mdrannex-i/chapter-i/6·chapter-i/article-2 - performance of an AI system 1 clause:
eu-ai-actchapter-i/article-3 - performance study 91 clauses:
eu-ivdrannex-i/chapter-iii·annex-ii/6.2·annex-vi/part-a/2.1·annex-vii/3.2.4·annex-vii/4.5.4·annex-xiii/part-a/1.2.2·annex-xiii/part-a/2.2·annex-xiii/part-a/2.3.1·annex-xiii/part-a/2.3.2·annex-xiii/part-a/2.3.3·annex-xiii/part-a/3·annex-xiv/chapter-i/1·annex-xiv/chapter-i/2·annex-xiv/chapter-i/2.8·annex-xiv/chapter-i/4.1·annex-xiv/chapter-ii/1·annex-xiv/chapter-ii/3·annex-xiv/chapter-ii/4·chapter-i/section-1/article-2·chapter-ii/article-10/5·chapter-ii/article-10/8·chapter-ii/article-19/1·chapter-iii/article-24/3·chapter-v/section-2/article-48/10·chapter-v/section-2/article-48/3·chapter-v/section-2/article-48/4·chapter-v/section-2/article-48/7·chapter-v/section-2/article-48/8·chapter-v/section-2/article-48/9·chapter-vi/article-57/1·chapter-vi/article-58/1·chapter-vi/article-58/3·chapter-vi/article-58/4·chapter-vi/article-58/5·chapter-vi/article-58/6·chapter-vi/article-58/7·chapter-vi/article-58/8·chapter-vi/article-59/2·chapter-vi/article-59/6·chapter-vi/article-59/7·chapter-vi/article-60/1·chapter-vi/article-60/3·chapter-vi/article-61/1·chapter-vi/article-61/2·chapter-vi/article-62·chapter-vi/article-64/1·chapter-vi/article-64/2·chapter-vi/article-64/3·chapter-vi/article-65/1·chapter-vi/article-65/2·chapter-vi/article-66/1·chapter-vi/article-66/3·chapter-vi/article-66/7·chapter-vi/article-67/1·chapter-vi/article-67/3·chapter-vi/article-67/4·chapter-vi/article-68·chapter-vi/article-68/1·chapter-vi/article-68/2·chapter-vi/article-68/3·chapter-vi/article-68/5·chapter-vi/article-69/1·chapter-vi/article-69/3·chapter-vi/article-70/1·chapter-vi/article-70/2·chapter-vi/article-71/1·chapter-vi/article-71/2·chapter-vi/article-71/3·chapter-vi/article-72/1·chapter-vi/article-72/3·chapter-vi/article-73·chapter-vi/article-73/1·chapter-vi/article-73/2·chapter-vi/article-73/3·chapter-vi/article-73/4·chapter-vi/article-73/5·chapter-vi/article-73/6·chapter-vi/article-73/7·chapter-vi/article-74/1·chapter-vi/article-74/10·chapter-vi/article-74/11·chapter-vi/article-74/2·chapter-vi/article-74/4·chapter-vi/article-74/8·chapter-vi/article-74/9·chapter-vi/article-76/1·chapter-vi/article-76/2·chapter-vi/article-76/3·chapter-vi/article-76/4·chapter-vi/article-76/6·chapter-vii/section-2/article-82/1 - performance study plan 13 clauses:
eu-ivdrannex-vii/4.5.4·annex-xiii/part-a/2.3.2·annex-xiii/part-a/3·annex-xiv/chapter-i/1·chapter-i/section-1/article-2·chapter-vi/article-58/5·chapter-vi/article-64/1·chapter-vi/article-67/4·chapter-vi/article-68/1·chapter-vi/article-73/2·chapter-vi/article-73/5·chapter-vi/article-76/1·chapter-vi/article-76/3 - personal data 8 clauses:
eu-ai-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/3·article-1/6;eu-ivdrchapter-vi/article-68/3·chapter-vi/article-69/3·chapter-x/article-113/3;eu-mdrchapter-x/article-123/3;nist-ai-600-112 - placing on the market 7 clauses:
eu-ai-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/3·article-1/6;eu-ivdrchapter-i/section-1/article-1/1·chapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5;eu-mdrchapter-i/article-2 - positive predictive value 2 clauses:
eu-ivdrannex-i/chapter-ii·chapter-i/section-1/article-2 - post-market monitoring system 3 clauses:
eu-ai-actchapter-i/article-3·chapter-ix/section-1/article-72/2;eu-digital-omnibus-aiarticle-1/6 - post-market surveillance 36 clauses:
eu-ivdrannex-iii/1·annex-ix/chapter-i/2.1·annex-ix/chapter-ii·annex-vii/4.10·annex-vii/4.11·annex-vii/4.5.2·annex-vii/4.5.4·annex-vii/4.8·annex-xiii/part-a/1.3.3·annex-xiii/part-b·chapter-i/section-1/article-2·chapter-ii/article-10/8·chapter-ii/article-15/3·chapter-ii/article-8/1·chapter-iii/article-30/2·chapter-iv/article-41/5·chapter-vi/article-56/6·chapter-vii/section-1/article-78/2·chapter-vii/section-1/article-78/3·chapter-vii/section-2/article-83/1·chapter-x/article-113/3;eu-mdrannex-iii·annex-ix/chapter-ii·annex-vii/4.10·annex-vii/4.11·annex-vii/4.5.2·annex-vii/4.5.5·annex-xiv/part-b·chapter-i/article-2·chapter-ii/article-10/9·chapter-iv/article-45/5·chapter-vi/article-61/11·chapter-vi/article-61/9·chapter-vii/section-1/article-83/2·chapter-vii/section-1/article-83/3·chapter-x/article-123/3 - post-remote biometric identification system 1 clause:
eu-ai-actchapter-i/article-3 - 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 - professional user 1 clause:
eu-mdrchapter-i/article-2 - profiling 1 clause:
eu-ai-actchapter-i/article-3 - protective device 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - provider 14 clauses:
ema-data-quality-framework10;eu-ai-actannex-iv/2·chapter-i/article-3·chapter-iii/section-2/article-13/3·chapter-iii/section-4/article-31/8·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-11-draft17;eu-gmp-annex-2210;fda-device-cybersecurity-20266;nist-ai-600-112;nistir-81837 - publicly accessible space 1 clause:
eu-ai-actchapter-i/article-3 - putting into service 11 clauses:
eu-ai-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/3·article-1/6;eu-ivdrchapter-i/section-1/article-1/1·chapter-i/section-1/article-2·chapter-ii/article-7·chapter-vi/article-67/3;eu-machinery-regulationannex-iii/part-b/5;eu-mdrchapter-i/article-2·chapter-ii/article-7·chapter-vi/article-71/3 - Quality 21 clauses:
ema-data-quality-framework10;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-vii/4.5.2;eu-mdrannex-vii/4.5.2;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;ich-q1413.2;ich-q2r2annex-2/2.1;ich-q9r125·8;nistir-81837 - Quality Risk Management 9 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-2210;eu-gmp-chapter-1chapter-1;eu-gmp-chapter-5part-1;fda-ai-guidance7;ich-q124;ich-q1413.2;ich-q9r18 - Quality System 11 clauses:
ema-data-quality-framework10;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-175;eu-gmp-chapter-1chapter-1;eu-gmp-chapter-2part-1;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;ich-q1413.2;ich-q9r18 - real-time remote biometric identification system 1 clause:
eu-ai-actchapter-i/article-3 - real-world testing plan 2 clauses:
eu-ai-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/6 - reasonably foreseeable misuse 5 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-2/article-13/3;eu-digital-omnibus-aiarticle-1/3;eu-machinery-regulationannex-iii/part-b/5;fda-device-cybersecurity-20266 - recall 10 clauses:
eu-ai-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/6;eu-gmp-annex-236;eu-gmp-chapter-1chapter-1;eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2;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 1 clause:
eu-ai-actchapter-i/article-3 - removable mechanical transmission device 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - representative 42 clauses:
ema-data-quality-framework10;eu-ai-actchapter-i/article-3·chapter-iii/section-2/article-13/3;eu-digital-omnibus-aiarticle-1/6;eu-gmp-annex-1annex-1/11;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/2.1·annex-ix/chapter-i/2.2·annex-vii/4.5.1·annex-xiii/part-a/2.3.2·annex-xiv/chapter-i/1·chapter-i/section-1/article-2·chapter-v/section-2/article-48/7·chapter-v/section-2/article-48/9·chapter-vi/article-58/4·chapter-vi/article-58/5·chapter-vi/article-58/6·chapter-vi/article-59/2·chapter-vi/article-59/7·chapter-vi/article-60/1·chapter-vi/article-61/1·chapter-vi/article-64/1·chapter-vi/article-64/2·chapter-vi/article-64/3;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-i/chapter-iii·annex-ix/chapter-i/2.2·annex-xiii/1·chapter-i/article-2·chapter-vi/article-62/4;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;ich-q1413.2;ich-q2r2annex-2/2.2;nist-ai-600-112·6;nistir-81837 - reprocessing 7 clauses:
eu-gmp-chapter-5part-1;eu-gmp-chapter-6part-1;eu-mdrannex-i/chapter-iii·chapter-i/article-2·chapter-ii/article-17/3·chapter-ii/article-17/5;ich-q9r125 - Requirements 10 clauses:
ema-data-quality-framework10;ema-pics-annex15-concept2;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-ivdrchapter-x/article-113/3;eu-machinery-regulationannex-iii/part-b/5;eu-mdrchapter-x/article-123/3;fda-device-cybersecurity-20266;ich-q124;nistir-81837 - Risk / risk 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 - Risk Acceptance 1 clause:
ich-q9r18 - Risk Analysis 1 clause:
ich-q9r18 - Risk Assessment 4 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18;nistir-81837 - Risk Control 1 clause:
ich-q9r18 - Risk Evaluation 1 clause:
ich-q9r18 - Risk Management 13 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-2210;eu-gmp-chapter-1chapter-1;eu-gmp-chapter-5part-1;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;ich-q1413.2;ich-q9r18;nist-ai-600-112;nist-ai-rmf6;nistir-81837 - Risk Reduction 1 clause:
ich-q9r18 - Risk Review 1 clause:
ich-q9r18 - ropes 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - safety component 1 clause:
eu-ai-actchapter-i/article-3 - safety function 2 clauses:
eu-ai-actchapter-i/article-3;eu-machinery-regulationannex-iii/part-b/5 - 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 - sensitive operational data 2 clauses:
eu-ai-actchapter-i/article-3·chapter-ix/section-1/article-72/2 - serious adverse event 6 clauses:
eu-gmp-annex-236;eu-ivdrchapter-i/section-1/article-2·chapter-vi/article-76/1·chapter-vi/article-76/2·chapter-vi/article-76/6;eu-mdrchapter-i/article-2 - serious incident 6 clauses:
eu-ai-actchapter-i/article-3;eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2·chapter-vii/section-2/article-82/1;eu-mdrannex-i/chapter-iii·chapter-i/article-2 - serious public health threat 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - significant cybersecurity risk 1 clause:
fda-device-cybersecurity-20266 - single-use device 4 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrannex-i/chapter-iii·annex-vi/part-a/2.1·chapter-i/article-2 - SMC 1 clause:
eu-digital-omnibus-aiarticle-1/3 - SME 4 clauses:
eu-digital-omnibus-aiarticle-1/3;eu-gmp-annex-11-draft17;eu-gmp-annex-2210;nist-ai-rmf6 - software 31 clauses:
ema-data-quality-framework10;eu-ai-actannex-iv/2·chapter-iii/section-2/article-13/3;eu-gmp-annex-11-draft17·17.5;eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii·annex-vi/part-c/6.2.2·annex-vii/3.2.2·annex-vii/3.2.5·annex-xiii/part-a/1.1·chapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-i/chapter-ii·annex-i/chapter-iii·annex-ii/1.1·annex-ii/6.1·annex-vi/part-c/6.5.2·annex-vii/3.2.5·annex-viii/chapter-iii·annex-xiv/part-a/3·annex-xv/chapter-ii/2.3·chapter-i/article-2;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q1413.2;ich-q9r125;nist-ai-600-112;nist-ai-rmf5.3·6;nistir-81837 - source code 1 clause:
fda-device-cybersecurity-20266 - special categories of personal data 2 clauses:
eu-ai-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/3 - specimen receptacle 1 clause:
eu-ivdrchapter-i/section-1/article-2 - sponsor 45 clauses:
eu-ivdrannex-xiii/part-a/2.3.2·annex-xiv/chapter-i·annex-xiv/chapter-i/1·annex-xiv/chapter-ii/1·annex-xiv/chapter-ii/3·annex-xiv/chapter-ii/4·chapter-i/section-1/article-2·chapter-vi/article-58/4·chapter-vi/article-58/5·chapter-vi/article-65/2·chapter-vi/article-66/1·chapter-vi/article-66/3·chapter-vi/article-66/7·chapter-vi/article-67/1·chapter-vi/article-67/3·chapter-vi/article-68/1·chapter-vi/article-68/2·chapter-vi/article-68/3·chapter-vi/article-69/1·chapter-vi/article-70/1·chapter-vi/article-71/1·chapter-vi/article-71/3·chapter-vi/article-72/1·chapter-vi/article-72/3·chapter-vi/article-73·chapter-vi/article-73/1·chapter-vi/article-73/3·chapter-vi/article-73/4·chapter-vi/article-73/5·chapter-vi/article-73/6·chapter-vi/article-74/1·chapter-vi/article-74/11·chapter-vi/article-74/2·chapter-vi/article-74/4·chapter-vi/article-74/7·chapter-vi/article-74/8·chapter-vi/article-76/1·chapter-vi/article-76/2·chapter-vi/article-76/3·chapter-vi/article-76/4;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:
ema-data-quality-framework10;eu-ai-actchapter-i/article-3;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-1512;eu-gmp-chapter-6part-1;eu-ivdrannex-ii/4·annex-vii/4.6·annex-xiii/part-a/1.2.2·chapter-i/section-1/article-2·chapter-ii/article-5/5·chapter-vi/article-60/1·chapter-vi/article-61/1·chapter-vi/article-64/1;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-ii/4·chapter-i/article-2;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q1413.2;ich-q2r2annex-2/4;ich-q9r18;nist-ai-600-112;nist-ai-rmf6 - Static test 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - subject 56 clauses:
ema-data-quality-framework10;eu-ai-actchapter-i/article-3·chapter-iii/section-5/article-43/4;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-2part-1;eu-gmp-chapter-6part-1;eu-ivdrannex-i/chapter-ii·annex-iii/1·annex-xiv/chapter-i/4.1·chapter-i/section-1/article-2·chapter-v/section-2/article-48/11·chapter-v/section-2/article-48/3·chapter-v/section-2/article-48/7·chapter-v/section-2/article-48/9·chapter-vi/article-58/2·chapter-vi/article-58/3·chapter-vi/article-58/5·chapter-vi/article-58/6·chapter-vi/article-59/2·chapter-vi/article-59/6·chapter-vi/article-60/1·chapter-vi/article-60/3·chapter-vi/article-61/1·chapter-vi/article-61/2·chapter-vi/article-64/1·chapter-vi/article-64/2·chapter-vi/article-64/3·chapter-vi/article-65/1·chapter-vi/article-66/7·chapter-vi/article-71/3·chapter-vi/article-73/2·chapter-vi/article-74/11·chapter-vi/article-74/8·chapter-vii/section-2/article-82/1;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-iii·annex-xv/chapter-ii/4.1·annex-xv/chapter-iii/7·chapter-i/article-2·chapter-vi/article-61/3·chapter-vi/article-62/4;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;ich-q1413.2;ich-q9r18;nist-ai-600-112;nist-ai-rmf5.3·6 - substantial modification 4 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-5/article-43/4;eu-ivdrchapter-vi/article-71/2·chapter-vi/article-71/3 - 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 - System / system 111 clauses:
ema-data-quality-framework10;ema-pics-annex15-concept2;eu-ai-actannex-iv/2·annex-iv/3·annex-iv/4·annex-iv/9·chapter-i/article-3·chapter-iii/section-2/article-13/3·chapter-iii/section-2/article-14/4·chapter-iii/section-2/article-15/5·chapter-iii/section-4/article-31/8·chapter-iii/section-5/article-40/2·chapter-iii/section-5/article-43/4·chapter-ix/section-1/article-72/2;eu-digital-omnibus-aiarticle-1/3·article-1/6;eu-gmp-annex-1annex-1/11;eu-gmp-annex-114.6;eu-gmp-annex-11-draft17·17.5;eu-gmp-annex-1512;eu-gmp-annex-175;eu-gmp-annex-236;eu-gmp-annex-2210·10.3·10.5;eu-gmp-chapter-1chapter-1;eu-gmp-chapter-2part-1;eu-gmp-chapter-5part-1;eu-gmp-chapter-6part-1;eu-ivdrannex-i/chapter-ii·annex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-ix/chapter-ii·annex-vi/part-a/2.1·annex-vii/3.1.1·annex-vii/4.10·annex-vii/4.5.1·annex-vii/4.5.2·annex-vii/4.6·annex-vii/4.8·annex-xiii/part-a/1.3.3·chapter-i/section-1/article-2·chapter-ii/article-10/8·chapter-ii/article-15/3·chapter-ii/article-8/1·chapter-iii/article-24/1·chapter-iii/article-30/2·chapter-v/section-2/article-50/1·chapter-v/section-2/article-52·chapter-vi/article-59/2·chapter-vi/article-59/6·chapter-vi/article-65/2·chapter-vi/article-66/1·chapter-vi/article-66/3·chapter-vi/article-69·chapter-vi/article-69/1·chapter-vi/article-69/2·chapter-vi/article-70/1·chapter-vi/article-71/1·chapter-vi/article-72/3·chapter-vi/article-73/1·chapter-vi/article-73/5·chapter-vi/article-73/7·chapter-vi/article-74/1·chapter-vi/article-74/11·chapter-vi/article-74/8·chapter-vi/article-76/2·chapter-vi/article-76/3·chapter-vi/article-76/4·chapter-vi/article-77·chapter-vii/section-1/article-78/2·chapter-vii/section-1/article-78/3·chapter-vii/section-2/article-82/1·chapter-vii/section-2/article-83/1·chapter-x/article-113/3;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-i/chapter-ii·annex-ii/1.1·annex-ix/chapter-i/2.2·annex-ix/chapter-ii·annex-vi/part-a/2.1·annex-vii/3.1.1·annex-vii/4.10·annex-vii/4.5.2·annex-viii/chapter-iii·chapter-i/article-2·chapter-ii/article-10/9·chapter-ii/article-17/3·chapter-v/section-2/article-55/1·chapter-v/section-2/article-57/1·chapter-vi/article-81·chapter-vii/section-1/article-83/2·chapter-vii/section-1/article-83/3·chapter-x/article-123/3;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;ich-q1413.2;ich-q2r2annex-2/2·annex-2/4;ich-q9r125·8;nist-ai-600-112·6;nist-ai-rmf1.1·3.1·5.2·5.3·6;nistir-81837 - systemic risk 1 clause:
eu-ai-actchapter-i/article-3 - technical specifications 2 clauses:
eu-ai-actchapter-i/article-3;eu-mdrannex-ii/1.1 - Test coefficient 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - testing data 5 clauses:
eu-ai-actannex-iv/2·chapter-i/article-3·chapter-iii/section-2/article-13/3;eu-digital-omnibus-aiarticle-1/3;eu-gmp-annex-1annex-1/11 - testing in real-world conditions 2 clauses:
eu-ai-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/6 - training data 8 clauses:
eu-ai-actannex-iv/2·chapter-i/article-3·chapter-iii/section-2/article-15/5;eu-gmp-annex-2210·10.5;fda-ai-guidance7;nist-ai-600-112·6 - Trend 1 clause:
eu-gmp-chapter-6part-1 - UDI 20 clauses:
eu-ivdrannex-i/chapter-iii·annex-vi/part-a/2.1·annex-vi/part-c/6.2.2·chapter-i/section-1/article-2·chapter-ii/article-10/8·chapter-iii/article-24/1·chapter-iii/article-24/3·chapter-iii/article-29/2·chapter-iii/article-30/2·chapter-x/article-113/3;eu-mdrannex-i/chapter-iii·annex-ii/1.1·annex-vi/part-a/2.1·annex-vi/part-c/4.10·annex-vi/part-c/6.5.2·chapter-i/article-2·chapter-ii/article-10/9·chapter-iii/article-32/2·chapter-x/article-123/3;fda-device-cybersecurity-20266 - Union harmonisation legislation 6 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-5/article-40/2;eu-digital-omnibus-aiarticle-1/6;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5;eu-mdrchapter-i/article-2 - Unique Device Identifier 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - Unit Operation 1 clause:
ich-q1413.2 - user 40 clauses:
eu-digital-omnibus-aiarticle-1/3;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17·17.5;eu-gmp-annex-1512;eu-gmp-annex-2210;eu-ivdrannex-i/chapter-i/6·annex-i/chapter-i/8·annex-i/chapter-ii·annex-i/chapter-iii·annex-ix/chapter-ii·annex-vi/part-c/6.2.2·annex-xiii/part-a/2.3.2·chapter-i/section-1/article-2·chapter-ii/article-7·chapter-iii/article-29/1·chapter-vi/article-57/1·chapter-vi/article-59/6·chapter-vi/article-71/3·chapter-vi/article-73/5;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-i/chapter-i/6·annex-i/chapter-i/8·annex-i/chapter-ii·annex-i/chapter-iii·annex-ii/1.1·annex-ii/6.1·annex-ix/chapter-ii·annex-vi/part-c/6.5.2·annex-xiii/1·annex-xiv/part-a/3·chapter-i/article-2·chapter-ii/article-7·chapter-iii/article-32/1;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-600-112;nist-ai-rmf5.2·6;nistir-81837 - validation data 4 clauses:
eu-ai-actchapter-i/article-3;ich-q124;ich-q1413.2;ich-q2r2annex-2/2 - validation data set 1 clause:
eu-ai-actchapter-i/article-3 - vulnerability 4 clauses:
eu-gmp-annex-11-draft17;fda-device-cybersecurity-20266;nist-ai-600-112;nistir-81837 - webbing 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - widespread infringement 1 clause:
eu-ai-actchapter-i/article-3 - withdrawal 7 clauses:
eu-ai-actchapter-i/article-3;eu-ivdrannex-vii/4.8·chapter-i/section-1/article-2·chapter-v/section-2/article-52·chapter-vi/article-58/6;eu-mdrchapter-i/article-2·chapter-v/section-2/article-57/1 - withdrawal of an AI system 1 clause:
eu-ai-actchapter-i/article-3 - Working coefficient 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - written 22 clauses:
eu-ai-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/6;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;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-ivdrannex-i/chapter-iii·annex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·chapter-i/section-1/article-2·chapter-iii/article-29/1;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-i/chapter-iii·annex-ix/chapter-i/2.2·annex-ix/chapter-ii·chapter-i/article-2·chapter-iii/article-32/1;ich-q124;nist-ai-600-112
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 |
|---|---|---|---|---|
90f72782b398 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
ebaf707c409d (current) | 0 | 6 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
e2ad4536a9bd unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
4d30b7bae7dd (current) | 0 | 1 | 0 |
| 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 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
58dbc3006d27 | 0 | 28 | 8 | |
9d16077b1d3b (current) | 0 | 28 | 8 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
9206a43954eb (current) | 0 | 7 | 2 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
1fe6027daa2c (current) | 0 | 13 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
92eb86f25281 (current) | 0 | 2 | 5 |
| 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 | 8 | 3 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
797a882ba0ea | 0 | 0 | 0 | |
53742d793b68 (current) | 0 | 2 | 0 | |
ac0054416554 | 0 | 0 | 0 | |
749c40132375 | 0 | 0 | 0 | |
f110d5d47c11 | 0 | 0 | 0 | |
bf56cba791d8 | 0 | 0 | 0 | |
3db9896305a6 | 0 | 0 | 0 |
| 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 | 3 | 3 |
| 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 | 0 | 1 |
| 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 | 2 | 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 | 0 | 1 |
| 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 | 0 | 3 |
| 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 | 0 | 1 |
| 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 | 0 | 0 | |
07dc6a9975d1 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
f8b98469078e (current) | 0 | 10 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
2cb8ccdb053c unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
743cfcdd11a7 (current) | 0 | 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 | 1 | 0 |
| 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 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
f30eb798ed40 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
172395cf624f (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
2ebf88652dc3 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
6ec505fc00ef (current) | 0 | 1 | 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 |
|---|---|---|---|---|
903e40aaebe6 (current) | 0 | 319 | 75 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
1fc20ae2ffd8 | 0 | 5 | 1 | |
82fb682a6c54 (current) | 0 | 5 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
14d00b77d5c8 | 1 | 121 | 17 | |
fab624c8e1dc (current) | 1 | 121 | 17 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
023dc18395dc (current) | 0 | 2 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
61d4603ff66e | 0 | 0 | 0 | |
088a7a37c55d | 0 | 0 | 0 | |
630bd27c7b42 | 0 | 0 | 0 | |
5c61f4c6351d (current) | 0 | 12 | 13 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
b52b706d5cca (current) | 0 | 0 | 0 | |
d34d8c706d88 | 0 | 4 | 3 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
b52b706d5cca | 0 | 0 | 0 | |
27c5d1a28e3d unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
d34d8c706d88 (current) | 0 | 4 | 3 |
| 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 | 1 | 0 |
| 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 | 6 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
ef0dfb4023b7 | 0 | 1 | 0 | |
2091aa6e2741 (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
206fc2d61445 (current) | 0 | 6 | 7 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
06273204f50b (current) | 0 | 9 | 24 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
5e9388123e17 (current) | 0 | 28 | 70 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
bb656b9e84a8 (current) | 0 | 11 | 24 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
57c484f5daed (current) | 0 | 0 | 6 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
c0ab0e6263b3 | 0 | 0 | 0 | |
edcebd0e3a36 | 0 | 0 | 0 | |
9d19d28e1a57 | 0 | 0 | 0 | |
f2734caa33bb | 0 | 0 | 0 | |
8727e7836a62 | 0 | 0 | 0 | |
e6bfd1f64b25 | 0 | 0 | 2 | |
67d33a19b1a7 | 0 | 0 | 2 | |
05c0bdbc196e | 0 | 0 | 2 | |
8e07db344887 | 0 | 0 | 2 | |
84a3e0382b0e | 0 | 0 | 2 | |
6f9c326c480f | 0 | 0 | 2 | |
b413d56295e8 | 0 | 0 | 2 | |
e3d94d289c0b | 0 | 0 | 2 | |
d800e5bf4d9b (current) | 0 | 0 | 2 |
| 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 | 6 | 21 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
8afebcc0941a | 0 | 0 | 0 | |
c240f2675bd3 | 0 | 0 | 0 | |
4c10dc03228b (current) | 0 | 2 | 6 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
eae63eec79c3 | 0 | 0 | 3 | |
3e7e350389ef (current) | 0 | 0 | 3 |
| 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 | 0 | 5 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
f0554d5c3fab | 0 | 1 | 0 | |
6a4d277ca4f8 | 0 | 1 | 0 | |
95bf4a66f2d4 | 0 | 1 | 0 | |
98ed07f87cdd | 0 | 1 | 0 | |
15f94377c4fc | 0 | 1 | 0 | |
9269c75204ff | 0 | 1 | 0 | |
4d93ac00b602 | 0 | 1 | 0 | |
825750c5633d | 0 | 1 | 0 | |
39db0dd17f53 | 0 | 1 | 0 | |
244eba4196bb | 0 | 1 | 0 | |
605180a389c7 | 0 | 1 | 0 | |
ed1c9acbb776 | 0 | 1 | 0 | |
bbbd805d0905 (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
393b48f902b8 | 0 | 5 | 0 | |
5997ebbb6661 | 0 | 5 | 0 | |
9d7b6d9aa4e1 | 0 | 5 | 0 | |
18e04a0c925a | 0 | 5 | 0 | |
1e7f13684129 | 0 | 5 | 0 | |
f24b92ecdf42 | 0 | 5 | 0 | |
b670ac9656b7 | 0 | 5 | 0 | |
bc527e48bcd8 | 0 | 5 | 0 | |
4edb9480421c | 0 | 5 | 0 | |
cd3e1c0c936b | 0 | 5 | 0 | |
75605421c92f (current) | 0 | 5 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
8b8ac787c687 | 0 | 1 | 2 | |
fa65ecef3a81 | 0 | 1 | 2 | |
8ee8e1aad0a5 | 0 | 1 | 2 | |
f3605b69e136 | 0 | 1 | 2 | |
baa155d883e3 | 0 | 1 | 2 | |
ac6e97a3c75d | 0 | 1 | 2 | |
bb66b9cbb2c4 | 0 | 1 | 2 | |
0e1bbcb2d14d | 0 | 1 | 2 | |
0eb9eade1868 | 0 | 1 | 2 | |
94a77d5625e8 | 0 | 1 | 2 | |
ca64082d7f23 (current) | 0 | 1 | 2 |
Feed
/atom/term/performance.atom carries one entry for each text of a row whose counts above differ from the row’s previous text, and one for the first text of a row holding the term, dated by the text’s first observation. A new version of the derivation is a change of method and is never an entry.
How this page is derived
From the terms-index derivation’s current version, first derived on
, read from
state/terms-index.jsonl. Threshold: a key enters the index when at least 1 observed text of a tracked row defines it, under the definitions derivation's current version. Its version, its rules and
term set, and the versions of the clause-anchor, definitions and sentence derivations it joins, are on
the derivation methods page, which lists every version of each with
the day it was first derived: a change there is a change of method, never a change in a text.
Not read: a term printed in a form no definition under its key carries: a plural or other ending, another letter case, another spacing or a line break between its words, a hyphenated or abbreviated form, a translation; a term a document defines in a form head 3's rules do not read (its own not_reached names them), which enters no key; an occurrence in a text head 1 refused, which is not read; a title is read for its row and is not dated by a text. A position states where an occurrence lies in a text and nothing about what the text says of the term.
| Entry | text_retained | licence_class | quote_allowed | snapshot_available |
|---|---|---|---|---|
| EU MDR | true | open | true | true |
| EU IVDR | true | open | true | true |
| EU Cybersecurity Act | true | open | true | true |
| EU Machinery Regulation | true | open | true | true |
| 21 CFR Part 11 | true | open | true | true |
| EU AI Act | true | open | true | true |
| EU GMP Annex 22 | true | open | true | true |
| FDA device cybersecurity | true | open | true | true |
| FDA device cybersecurity (2026) | true | open | true | true |
| EU GMP Annex 11 | true | open | true | true |
| FDA electronic systems (clinical) | true | open | true | true |
| EU Cyber Resilience Act | true | open | true | true |
| 21 CFR Part 820 (QMSR) | true | open | true | true |
| EU NIS2 Directive | true | open | true | true |
| ICH Q9(R1) | 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: