representative
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 NIS2 Directive
chapter-i/article-6(34): text withheld (over the cap: its term and text are 112 words) - Rows printing it in a normative sentence
- 20
- Rows printing it in a title
- 0
- Rows printing it in body
- 11
International
- Defined in
- no current text of a row of this jurisdiction defines it
- Rows printing it in a normative sentence
- 4
- Rows printing it in a title
- 0
- Rows printing it in body
- 3
US
- Defined in
- no current text of a row of this jurisdiction defines it
- Rows printing it in a normative sentence
- 4
- Rows printing it in a title
- 0
- Rows printing it in body
- 3
This form is printed by the
tracked documents, each as a document defines it. The index’s key is
representative (the definitions derivation’s fold:
case set aside, spaces collapsed; each form is matched exactly as printed).
1 observed text defines 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 NIS2 Directive
EUtext first observedchapter-i/article-6(34)representative: text withheld (over the cap: its term and text are 112 words)
In normative sentences
336 sentences in 28 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 observedfollows a withheld heading: 2 sentences (should) · id repeats in this text: 4 sentences (should) - EU AI Act
EU39 sentences; text first observedno clause anchor before this sentence: 2 sentences (should) ·chapter-i/article-3: 1 sentence (may, shall) ·chapter-iii/section-2/article-10/3: 1 sentence (shall) ·chapter-iii/section-2/article-13/3: 1 sentence (shall, may) ·chapter-iii/section-3/article-18/2: 1 sentence (shall) ·chapter-iii/section-3/article-20/1: 1 sentence (shall) ·chapter-iii/section-3/article-22/1: 1 sentence (shall) ·chapter-iii/section-3/article-22/2: 1 sentence (shall) ·chapter-iii/section-3/article-22/3: 3 sentences (shall) ·chapter-iii/section-3/article-22/4: 1 sentence (shall) ·chapter-iii/section-3/article-23/1: 1 sentence (shall) ·chapter-iii/section-3/article-23/2: 1 sentence (shall) ·chapter-iii/section-3/article-26/4: 1 sentence (shall) ·chapter-iii/section-5/article-48/4: 1 sentence (shall) ·chapter-iii/section-5/article-49/1: 1 sentence (shall) ·chapter-iii/section-5/article-49/2: 1 sentence (shall) ·chapter-v/section-2/article-54/1: 1 sentence (shall) ·chapter-v/section-2/article-54/2: 1 sentence (shall) ·chapter-v/section-2/article-54/3: 2 sentences (shall) ·chapter-v/section-2/article-54/4: 1 sentence (shall) ·chapter-v/section-2/article-54/5: 1 sentence (shall) ·chapter-vi/article-60/4: 1 sentence (may, shall) ·chapter-vi/article-60/5: 1 sentence (may) ·chapter-vi/article-61/1: 1 sentence (shall, may) ·chapter-vi/article-61/2: 1 sentence (shall) ·chapter-vii/section-1/article-65/2: 1 sentence (shall) ·chapter-vii/section-1/article-65/3: 1 sentence (shall) ·chapter-viii/article-71/2: 1 sentence (shall) ·chapter-ix/section-3/article-83/1: 1 sentence (shall, may) ·chapter-ix/section-5/article-91/5: 1 sentence (shall) ·chapter-ix/section-5/article-92/5: 1 sentence (shall) ·chapter-x/article-95/3: 1 sentence (may) ·annex-vii/3.1: 1 sentence (shall) ·annex-vii/3.2: 1 sentence (shall) ·annex-vii/4.6: 1 sentence (shall) - EU Cyber Resilience Act
EU21 sentences; text first observedno clause anchor before this sentence: 4 sentences (should) ·chapter-i/article-3: 1 sentence (may) ·chapter-ii/article-14/7: 1 sentence (shall) ·chapter-ii/article-18/1: 1 sentence (may) ·chapter-ii/article-18/2: 1 sentence (shall) ·chapter-ii/article-18/3: 3 sentences (shall) ·chapter-iii/article-30/4: 1 sentence (shall) ·chapter-iv/article-39/4: 1 sentence (shall) ·chapter-vii/article-65: 1 sentence (shall, may) ·annex-viii/part-i/5: 1 sentence (may) ·annex-viii/part-ii/3: 1 sentence (shall) ·annex-viii/part-ii/11: 1 sentence (may) ·annex-viii/part-iii/4: 1 sentence (may) ·annex-viii/part-iv/3.1: 1 sentence (shall) ·annex-viii/part-iv/3.3: 1 sentence (shall) ·annex-viii/part-iv/8: 1 sentence (may) - EU Cybersecurity Act
EU2 sentences; text first observedtitle-ii/chapter-iii/section-4/article-23/1: 1 sentence (shall) ·title-iv/article-69/4: 1 sentence (shall) - Regulation (EU) 2026/1744
EU3 sentences; text first observedarticle-1/6: 3 sentences (shall) - EU GMP Annex 1
EU18 sentences; text first observedannex-1/11: 18 sentences (should) - EU GMP Annex 12
EU2 sentences; text first observed17: 1 sentence (should) ·25: 1 sentence (should) - EU GMP Annex 13
EU3 sentences; text first observed5.2: 1 sentence (should) ·6.3: 1 sentence (should) ·11.3: 1 sentence (should) - EU GMP Annex 15
EU1 sentence; text first observed10.6.2: 1 sentence (may) - EU GMP Annex 16
EU1 sentence; text first observed1.5.5: 1 sentence (should) - EU GMP Annex 17
EU1 sentence; text first observed5: 1 sentence (should) - EU GMP Annex 19
EU1 sentence; text first observed4.3: 1 sentence (should) - EU GMP Annex 2
EU1 sentence; text first observed36: 1 sentence (may) - EU GMP Annex 22
EU1 sentence; text first observed10: 1 sentence (should) - EU GMP Annex 8
EU2 sentences; text first observed4: 2 sentences (may, should) - EU GMP Chapter 6
EU1 sentence; text first observedpart-1: 1 sentence (should) - EU IVDR
EU82 sentences; text first observedno clause anchor before this sentence: 3 sentences (should) ·chapter-i/section-1/article-2: 1 sentence (shall, may) ·chapter-i/section-2/article-4/1: 1 sentence (shall) ·chapter-ii/article-10/7: 1 sentence (shall) ·chapter-ii/article-10/11: 1 sentence (shall) ·chapter-ii/article-11/1: 1 sentence (may) ·chapter-ii/article-11/2: 1 sentence (shall) ·chapter-ii/article-11/3: 3 sentences (shall) ·chapter-ii/article-11/5: 1 sentence (shall) ·chapter-ii/article-11/6: 1 sentence (shall) ·chapter-ii/article-11/7: 1 sentence (shall) ·chapter-ii/article-12: 2 sentences (shall, may) ·chapter-ii/article-13/2: 2 sentences (shall) ·chapter-ii/article-13/6: 1 sentence (shall) ·chapter-ii/article-13/7: 2 sentences (shall) ·chapter-ii/article-13/8: 1 sentence (shall) ·chapter-ii/article-14/2: 2 sentences (may, shall) ·chapter-ii/article-14/4: 2 sentences (shall) ·chapter-ii/article-14/5: 2 sentences (shall) ·chapter-ii/article-14/6: 1 sentence (shall) ·chapter-iii/article-27/1: 1 sentence (shall) ·chapter-iii/article-27/3: 2 sentences (shall) ·chapter-iii/article-28/2: 1 sentence (shall) ·chapter-iii/article-28/8: 1 sentence (may) ·chapter-iv/article-35/3: 1 sentence (shall) ·chapter-iv/article-41/2: 1 sentence (shall) ·chapter-v/section-1/article-47/2: 1 sentence (shall) ·chapter-v/section-2/article-48/7: 1 sentence (shall) ·chapter-v/section-2/article-48/9: 1 sentence (shall) ·chapter-v/section-2/article-48/13: 1 sentence (may) ·chapter-v/section-2/article-55/1: 1 sentence (shall, may) ·chapter-vi/article-58/4: 3 sentences (shall) ·chapter-vi/article-58/5: 1 sentence (may) ·chapter-vi/article-58/6: 1 sentence (may) ·chapter-vi/article-59/1: 1 sentence (shall) ·chapter-vi/article-59/2: 3 sentences (shall) ·chapter-vi/article-59/3: 1 sentence (shall) ·chapter-vi/article-59/7: 1 sentence (shall) ·chapter-vi/article-60/1: 1 sentence (may) ·chapter-vi/article-61/1: 1 sentence (may, shall) ·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-vii/section-2/article-85: 1 sentence (shall) ·chapter-vii/section-3/article-90/1: 1 sentence (shall) ·annex-i/chapter-iii: 1 sentence (shall, may) ·annex-vi/part-b: 1 sentence (shall) ·annex-vii/1.2.3: 2 sentences (shall) ·annex-vii/4.3: 1 sentence (shall) ·annex-vii/4.5.1: 1 sentence (shall) ·annex-ix/chapter-i/2.1: 1 sentence (shall) ·annex-ix/chapter-i/2.2: 1 sentence (shall) ·annex-ix/chapter-i/2.3: 2 sentences (shall) ·annex-ix/chapter-i/3.2: 1 sentence (shall) ·annex-ix/chapter-i/3.5: 1 sentence (shall) ·annex-ix/chapter-iii: 2 sentences (shall) ·annex-x/2: 3 sentences (shall) ·annex-x/6: 1 sentence (shall) ·annex-xi/6: 1 sentence (shall) ·annex-xiii/part-a/2.3.2: 1 sentence (shall) ·annex-xiv/chapter-i/1: 1 sentence (shall) - EU Machinery Regulation
EU27 sentences; text first observedno clause anchor before this sentence: 1 sentence (should) ·chapter-i/article-3: 1 sentence (may) ·chapter-ii/article-12/1: 2 sentences (may, shall) ·chapter-ii/article-12/2: 2 sentences (shall) ·chapter-iii/article-24/3: 1 sentence (shall) ·chapter-v/article-30/4: 1 sentence (shall) ·chapter-vii/article-48/5: 1 sentence (may) ·annex-iii/part-b/5: 6 sentences (may, shall, must, should) ·annex-vi/5: 1 sentence (may) ·annex-vii/2: 1 sentence (shall) ·annex-vii/3: 2 sentences (shall) ·annex-vii/6.2: 1 sentence (shall) ·annex-vii/10: 1 sentence (may) ·annex-viii/4: 1 sentence (may) ·annex-ix/3.1: 1 sentence (shall) ·annex-ix/3.3: 1 sentence (shall) ·annex-ix/8: 1 sentence (may) ·annex-x/2: 1 sentence (shall) ·annex-x/6: 1 sentence (may) - EU MDR
EU90 sentences; text first observedno clause anchor before this sentence: 3 sentences (should) ·chapter-i/article-2: 1 sentence (shall, may) ·chapter-ii/article-10/8: 1 sentence (shall) ·chapter-ii/article-10/12: 1 sentence (shall) ·chapter-ii/article-11/1: 1 sentence (may) ·chapter-ii/article-11/2: 1 sentence (shall) ·chapter-ii/article-11/3: 3 sentences (shall) ·chapter-ii/article-11/5: 1 sentence (shall) ·chapter-ii/article-11/6: 1 sentence (shall) ·chapter-ii/article-11/7: 1 sentence (shall) ·chapter-ii/article-12: 2 sentences (shall, may) ·chapter-ii/article-13/2: 2 sentences (shall) ·chapter-ii/article-13/6: 1 sentence (shall) ·chapter-ii/article-13/7: 2 sentences (shall) ·chapter-ii/article-13/8: 1 sentence (shall) ·chapter-ii/article-14/2: 2 sentences (may, shall) ·chapter-ii/article-14/4: 2 sentences (shall) ·chapter-ii/article-14/5: 2 sentences (shall) ·chapter-ii/article-14/6: 1 sentence (shall) ·chapter-iii/article-30/1: 1 sentence (shall) ·chapter-iii/article-30/3: 2 sentences (shall) ·chapter-iii/article-31/2: 1 sentence (shall) ·chapter-iii/article-31/8: 1 sentence (may) ·chapter-iv/article-39/3: 1 sentence (shall) ·chapter-iv/article-45/2: 1 sentence (shall) ·chapter-v/section-1/article-51/2: 1 sentence (shall) ·chapter-v/section-2/article-52/4: 1 sentence (shall) ·chapter-v/section-2/article-52/6: 2 sentences (shall) ·chapter-v/section-2/article-52/14: 1 sentence (may) ·chapter-v/section-2/article-60/1: 1 sentence (shall, may) ·chapter-vi/article-62/2: 3 sentences (shall) ·chapter-vi/article-62/4: 1 sentence (may) ·chapter-vi/article-62/5: 1 sentence (may) ·chapter-vi/article-63/1: 1 sentence (shall) ·chapter-vi/article-63/2: 3 sentences (shall) ·chapter-vi/article-63/3: 1 sentence (shall) ·chapter-vi/article-63/7: 1 sentence (shall) ·chapter-vi/article-64/1: 1 sentence (may) ·chapter-vi/article-65: 1 sentence (may, shall) ·chapter-vi/article-68/1: 1 sentence (may) ·chapter-vi/article-68/2: 2 sentences (shall) ·chapter-vi/article-68/3: 1 sentence (shall) ·chapter-vii/section-2/article-90: 1 sentence (shall) ·chapter-vii/section-3/article-95/1: 1 sentence (shall) ·chapter-viii/article-103/5: 1 sentence (shall) ·annex-i/chapter-iii: 1 sentence (shall, may) ·annex-vi/part-b: 1 sentence (shall) ·annex-vii/1.2.3: 2 sentences (shall) ·annex-vii/4.3: 1 sentence (shall) ·annex-vii/4.5.1: 1 sentence (shall) ·annex-ix/chapter-i/2.1: 1 sentence (shall) ·annex-ix/chapter-i/2.2: 1 sentence (shall) ·annex-ix/chapter-i/2.3: 2 sentences (shall) ·annex-ix/chapter-i/3.2: 1 sentence (shall) ·annex-ix/chapter-i/3.5: 1 sentence (shall) ·annex-ix/chapter-iii: 2 sentences (shall) ·annex-x/2: 3 sentences (shall, may) ·annex-x/7: 1 sentence (shall) ·annex-xi/part-a: 4 sentences (shall) ·annex-xi/part-b: 2 sentences (shall) ·annex-xiii/1: 1 sentence (shall) ·annex-xv/chapter-i/2.4: 1 sentence (shall) ·annex-xv/chapter-ii/1: 1 sentence (shall) ·annex-xv/chapter-iii/3: 1 sentence (shall) - EU NIS2 Directive
EU13 sentences; text first observedno clause anchor before this sentence: 4 sentences (should) ·chapter-i/article-6: 1 sentence (may) ·chapter-v/article-26/3: 4 sentences (shall, may) ·chapter-v/article-26/4: 1 sentence (shall) ·chapter-v/article-27/2: 1 sentence (shall) ·chapter-vii/article-32/5: 1 sentence (shall) ·chapter-vii/article-32/6: 1 sentence (shall) - FDA AI guidance
US3 sentences; text first observed7: 3 sentences (should) - FDA device cybersecurity (2026)
US1 sentence; text first observed6: 1 sentence (may) - ICH Q12
International1 sentence; text first observed4: 1 sentence (may) - ICH Q13
International4 sentences; text first observedfollows a withheld heading: 3 sentences (should, may) · id repeats in this text: 1 sentence (should) - ICH Q14
International1 sentence; text first observed13.2: 1 sentence (should) - ICH Q2(R2)
International2 sentences; text first observedannex-2/2.2: 1 sentence (should) · id repeats in this text: 1 sentence (may) - NIST AI 600-1
US1 sentence; text first observed6: 1 sentence (may) - 21 CFR Part 211
US8 sentences; text first observedno numbering read: 8 sentences (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
54 occurrences in 17 current texts outside every sentence above and outside the term’s own definitions, each counted under the clause anchor the clause-anchor derivation placed last before it; each clause is followed by its count.
- EMA CT computerised systems
EU1 occurrence; text first observed1 where the heading before it is withheld - EMA data quality framework
EU1 occurrence; text first observed10: 1 - EU AI Act
EU5 occurrences; text first observedannex-v/2: 1 ·annex-viii/13: 1 ·annex-viii/3: 1 ·chapter-xiii/article-113: 1 · 1 where no heading is read before it - EU Cyber Resilience Act
EU3 occurrences; text first observedannex-v/2: 1 ·chapter-viii/article-71/2: 1 · 1 where no heading is read before it - EU GMP Annex 1
EU2 occurrences; text first observedannex-1/11: 2 - EU GMP Annex 13
EU1 occurrence; text first observed11.1: 1 - EU GMP Annex 16
EU3 occurrences; text first observed1.5.6: 2 ·1.5.7: 1 - EU GMP Annex 8
EU1 occurrence; text first observed1 where no heading is read before it - EU IVDR
EU8 occurrences; text first observedannex-iv/1: 1 ·annex-vi/part-a/1: 1 ·annex-x/1: 1 ·annex-xii/chapter-ii: 1 ·chapter-i/section-1/article-2: 2 ·chapter-ii/article-11: 1 · 1 where no heading is read before it - EU Machinery Regulation
EU2 occurrences; text first observedannex-v/part-a/2: 1 ·annex-v/part-b/2: 1 - EU MDR
EU7 occurrences; text first observedannex-iv/1: 1 ·annex-vi/part-a/1: 1 ·annex-x/1: 1 ·annex-xii/chapter-ii: 1 ·annex-xv/chapter-ii/3.1.2: 1 ·chapter-ii/article-11: 1 · 1 where no heading is read before it - FDA AI guidance
US4 occurrences; text first observed7: 4 - ICH Q13
International1 occurrence; text first observed1 where the heading before it is withheld - ICH Q14
International6 occurrences; text first observed13.2: 5 · 1 where the heading before it is withheld - NIST AI 600-1
US7 occurrences; text first observed12: 7 - NIST AI RMF
International1 occurrence; text first observed3.7: 1 - NISTIR 8183
US1 occurrence; text first observed7: 1
Co-occurrence
266 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. 44 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-ai-actchapter-xiii/article-113;eu-cyber-resilience-actchapter-viii/article-71/2;eu-machinery-regulationchapter-i/article-3 - Act 5 clauses:
eu-ai-actchapter-xiii/article-113;eu-cyber-resilience-actchapter-viii/article-71/2;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124 - active device 1 clause:
eu-mdrchapter-i/article-2 - actively exploited vulnerability 2 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-14/7 - adverse event 4 clauses:
ema-data-quality-framework10;eu-gmp-annex-236;eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - Agency 8 clauses:
ema-data-quality-framework10;eu-ai-actchapter-xiii/article-113;eu-cyber-resilience-actchapter-viii/article-71/2;eu-ivdrannex-ix/chapter-iii;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 1 clause:
eu-ai-actchapter-i/article-3 - AI Office 6 clauses:
eu-ai-actchapter-i/article-3·chapter-v/section-2/article-54/3·chapter-v/section-2/article-54/4·chapter-v/section-2/article-54/5·chapter-vii/section-1/article-65/2;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 19 clauses:
eu-ai-actannex-vii/3.1·annex-vii/4.6·annex-viii/13·chapter-i/article-3·chapter-iii/section-2/article-10/3·chapter-iii/section-2/article-13/3·chapter-iii/section-3/article-20/1·chapter-iii/section-3/article-22/3·chapter-iii/section-3/article-23/1·chapter-iii/section-3/article-23/2·chapter-iii/section-3/article-26/4·chapter-iii/section-5/article-48/4·chapter-iii/section-5/article-49/1·chapter-iii/section-5/article-49/2·chapter-vi/article-60/4·chapter-vi/article-61/1;eu-digital-omnibus-aiarticle-1/6;nist-ai-600-112;nist-ai-rmf3.7 - allow-list 1 clause:
fda-device-cybersecurity-20266 - analytical performance 4 clauses:
eu-ivdrannex-i/chapter-iii·annex-xiii/part-a/2.3.2·chapter-i/section-1/article-2·chapter-vi/article-58/5 - Application 14 clauses:
eu-ivdrannex-vii/4.3·annex-x/2·annex-xiv/chapter-i/1;eu-machinery-regulationannex-iii/part-b/5·annex-vii/3;eu-mdrannex-vii/4.3·annex-x/2·annex-xi/part-a·annex-xi/part-b·annex-xv/chapter-ii/1;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;nistir-81837 - assurance level 1 clause:
eu-gmp-annex-1annex-1/11 - authorised representative 141 clauses:
eu-ai-actannex-v/2·annex-vii/3.1·annex-vii/3.2·annex-vii/4.6·annex-viii/13·annex-viii/3·chapter-i/article-3·chapter-iii/section-2/article-13/3·chapter-iii/section-3/article-18/2·chapter-iii/section-3/article-20/1·chapter-iii/section-3/article-22/1·chapter-iii/section-3/article-22/2·chapter-iii/section-3/article-22/3·chapter-iii/section-3/article-22/4·chapter-iii/section-3/article-23/1·chapter-iii/section-3/article-23/2·chapter-iii/section-5/article-48/4·chapter-iii/section-5/article-49/1·chapter-iii/section-5/article-49/2·chapter-ix/section-3/article-83/1·chapter-v/section-2/article-54/1·chapter-v/section-2/article-54/2·chapter-v/section-2/article-54/3·chapter-v/section-2/article-54/4·chapter-v/section-2/article-54/5·chapter-viii/article-71/2;eu-cyber-resilience-actannex-v/2·annex-viii/part-i/5·annex-viii/part-ii/11·annex-viii/part-ii/3·annex-viii/part-iii/4·annex-viii/part-iv/3.1·annex-viii/part-iv/3.3·annex-viii/part-iv/8·chapter-i/article-3·chapter-ii/article-14/7·chapter-ii/article-18/1·chapter-ii/article-18/2·chapter-ii/article-18/3·chapter-iii/article-30/4·chapter-iv/article-39/4;eu-cybersecurity-acttitle-iv/article-69/4;eu-ivdrannex-i/chapter-iii·annex-iv/1·annex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-ix/chapter-iii·annex-vi/part-a/1·annex-vi/part-b·annex-vii/1.2.3·annex-vii/4.3·annex-x/2·annex-x/6·annex-xi/6·annex-xii/chapter-ii·annex-xiv/chapter-i/1·chapter-i/section-1/article-2·chapter-ii/article-10/11·chapter-ii/article-10/7·chapter-ii/article-11/1·chapter-ii/article-11/2·chapter-ii/article-11/3·chapter-ii/article-11/5·chapter-ii/article-11/6·chapter-ii/article-11/7·chapter-ii/article-12·chapter-ii/article-13/2·chapter-ii/article-13/6·chapter-ii/article-13/7·chapter-ii/article-13/8·chapter-ii/article-14/2·chapter-ii/article-14/4·chapter-ii/article-14/5·chapter-ii/article-14/6·chapter-iii/article-27/1·chapter-iii/article-27/3·chapter-iii/article-28/2·chapter-iii/article-28/8·chapter-v/section-1/article-47/2·chapter-v/section-2/article-55/1·chapter-vii/section-2/article-85·chapter-vii/section-3/article-90/1;eu-machinery-regulationannex-iii/part-b/5·annex-ix/3.1·annex-ix/3.3·annex-ix/8·annex-v/part-a/2·annex-v/part-b/2·annex-vi/5·annex-vii/10·annex-vii/3·annex-vii/6.2·annex-viii/4·annex-x/2·annex-x/6·chapter-i/article-3·chapter-ii/article-12/1·chapter-ii/article-12/2·chapter-iii/article-24/3;eu-mdrannex-i/chapter-iii·annex-iv/1·annex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-ix/chapter-iii·annex-vi/part-a/1·annex-vi/part-b·annex-vii/1.2.3·annex-vii/4.3·annex-x/2·annex-x/7·annex-xi/part-a·annex-xi/part-b·annex-xii/chapter-ii·annex-xiii/1·annex-xv/chapter-ii/1·chapter-i/article-2·chapter-ii/article-10/12·chapter-ii/article-10/8·chapter-ii/article-11/1·chapter-ii/article-11/2·chapter-ii/article-11/3·chapter-ii/article-11/5·chapter-ii/article-11/6·chapter-ii/article-11/7·chapter-ii/article-12·chapter-ii/article-13/2·chapter-ii/article-13/6·chapter-ii/article-13/7·chapter-ii/article-13/8·chapter-ii/article-14/2·chapter-ii/article-14/4·chapter-ii/article-14/5·chapter-ii/article-14/6·chapter-iii/article-30/1·chapter-iii/article-30/3·chapter-iii/article-31/2·chapter-iii/article-31/8·chapter-v/section-1/article-51/2·chapter-v/section-2/article-60/1·chapter-vii/section-2/article-90·chapter-vii/section-3/article-95/1 - Autonomous mobile machinery 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - benefit-risk determination 4 clauses:
eu-ivdrchapter-i/section-1/article-2·chapter-vii/section-2/article-85;eu-mdrchapter-i/article-2·chapter-vii/section-2/article-90 - 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 11 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-23/1·chapter-iii/section-5/article-48/4·chapter-ix/section-3/article-83/1;eu-cyber-resilience-actchapter-i/article-3·chapter-iii/article-30/4;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3·chapter-iii/article-24/3;eu-mdrchapter-i/article-2·chapter-v/section-2/article-60/1 - CE marking of conformity 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - chains 5 clauses:
eu-gmp-annex-236;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;ich-q124;nist-ai-600-112 - clinical benefit 3 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrannex-i/chapter-iii·chapter-i/article-2 - clinical data 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - clinical evaluation 8 clauses:
eu-ivdrannex-ix/chapter-i/2.2;eu-mdrannex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-vii/4.5.1·annex-xv/chapter-i/2.4·annex-xv/chapter-ii/1·chapter-i/article-2·chapter-vi/article-62/4 - clinical evidence 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - clinical investigation 16 clauses:
eu-mdrannex-i/chapter-iii·annex-xv/chapter-i/2.4·annex-xv/chapter-ii/1·annex-xv/chapter-iii/3·chapter-i/article-2·chapter-vi/article-62/2·chapter-vi/article-62/4·chapter-vi/article-62/5·chapter-vi/article-63/2·chapter-vi/article-63/7·chapter-vi/article-64/1·chapter-vi/article-65·chapter-vi/article-68/1·chapter-vi/article-68/2·chapter-vi/article-68/3;fda-ai-guidance7 - clinical investigation plan 5 clauses:
eu-mdrannex-xv/chapter-i/2.4·annex-xv/chapter-ii/1·chapter-i/article-2·chapter-vi/article-62/4·chapter-vi/article-68/1 - clinical performance 8 clauses:
eu-ivdrannex-i/chapter-iii·annex-xiii/part-a/2.3.2·annex-xiv/chapter-i/1·chapter-i/section-1/article-2·chapter-vi/article-58/5·chapter-vi/article-64/1;eu-mdrannex-i/chapter-iii·chapter-i/article-2 - Closed system 2 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-236 - cloud computing service 1 clause:
eu-nis2chapter-i/article-6 - common specification 1 clause:
eu-ai-actchapter-i/article-3 - companion diagnostic 2 clauses:
eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2 - Component / component 10 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-gmp-annex-1annex-1/11;eu-gmp-annex-236;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-600-112;nistir-81837 - conformity assessment 43 clauses:
eu-ai-actannex-vii/4.6·chapter-i/article-3·chapter-iii/section-2/article-13/3·chapter-iii/section-3/article-22/3·chapter-iii/section-3/article-23/1·chapter-iii/section-5/article-48/4;eu-cyber-resilience-actchapter-i/article-3·chapter-iii/article-30/4·chapter-iv/article-39/4;eu-cybersecurity-acttitle-iv/article-69/4;eu-digital-omnibus-aiarticle-1/6;eu-ivdrannex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-vii/1.2.3·annex-vii/4.3·annex-vii/4.5.1·annex-xii/chapter-ii·chapter-i/section-1/article-2·chapter-ii/article-11/3·chapter-ii/article-11/6·chapter-iv/article-35/3·chapter-v/section-2/article-48/13·chapter-v/section-2/article-48/7·chapter-v/section-2/article-48/9;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3·chapter-iii/article-24/3·chapter-v/article-30/4;eu-mdrannex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-vii/1.2.3·annex-vii/4.3·annex-vii/4.5.1·annex-xi/part-a·annex-xii/chapter-ii·chapter-i/article-2·chapter-ii/article-11/3·chapter-ii/article-11/6·chapter-iv/article-39/3·chapter-v/section-2/article-52/14·chapter-v/section-2/article-52/4·chapter-v/section-2/article-52/6;nist-ai-600-112 - conformity assessment body 10 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3·chapter-iv/article-39/4;eu-cybersecurity-acttitle-iv/article-69/4;eu-ivdrchapter-i/section-1/article-2·chapter-iv/article-35/3;eu-machinery-regulationchapter-i/article-3·chapter-v/article-30/4;eu-mdrchapter-i/article-2·chapter-iv/article-39/3 - consumer 4 clauses:
eu-ai-actchapter-xiii/article-113;eu-cyber-resilience-actchapter-i/article-3;nist-ai-600-112;nistir-81837 - content delivery network 1 clause:
eu-nis2chapter-i/article-6 - control material 1 clause:
eu-ivdrchapter-i/section-1/article-2 - corrective action 16 clauses:
eu-gmp-annex-1annex-1/11;eu-ivdrchapter-i/section-1/article-2·chapter-ii/article-10/11·chapter-ii/article-11/3·chapter-ii/article-13/7·chapter-ii/article-14/4·chapter-vii/section-3/article-90/1;eu-mdrannex-vi/part-b·chapter-i/article-2·chapter-ii/article-10/12·chapter-ii/article-11/3·chapter-ii/article-13/7·chapter-ii/article-14/4·chapter-vii/section-3/article-95/1;fda-device-cybersecurity-20266;ich-q124 - critical infrastructure 3 clauses:
eu-ai-actchapter-i/article-3;nist-ai-600-112;nistir-81837 - CSIRT designated as coordinator 2 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-14/7 - custom-made device 3 clauses:
eu-mdrannex-i/chapter-iii·chapter-i/article-2·chapter-iii/article-30/3 - cyber threat 3 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-nis2chapter-i/article-6;fda-device-cybersecurity-20266 - cybersecurity 11 clauses:
eu-ai-actchapter-iii/section-2/article-13/3·chapter-xiii/article-113;eu-cyber-resilience-actannex-viii/part-ii/3·chapter-i/article-3·chapter-ii/article-14/7·chapter-viii/article-71/2;eu-nis2chapter-i/article-6;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-600-112;nistir-81837 - cybersecurity risk 6 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-nis2chapter-i/article-6;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-600-112;nistir-81837 - danger zone 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - data centre service 1 clause:
eu-nis2chapter-i/article-6 - deep fake 1 clause:
eu-ai-actchapter-i/article-3 - deployer 5 clauses:
eu-ai-actannex-viii/13·chapter-i/article-3·chapter-iii/section-3/article-26/4·chapter-vi/article-60/4;eu-digital-omnibus-aiarticle-1/6 - derivative 6 clauses:
eu-mdrannex-i/chapter-iii·annex-xi/part-a·annex-xi/part-b·annex-xiii/1·annex-xv/chapter-ii/1·chapter-i/article-2 - device deficiency 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - device for near-patient testing 1 clause:
eu-ivdrchapter-i/section-1/article-2 - device for performance study 3 clauses:
eu-ivdrannex-i/chapter-iii·annex-xiv/chapter-i/1·chapter-i/section-1/article-2 - device for self-testing 1 clause:
eu-ivdrchapter-i/section-1/article-2 - device software function 1 clause:
fda-device-cybersecurity-20266 - diagnostic sensitivity 2 clauses:
eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2 - diagnostic specificity 2 clauses:
eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2 - digital service 1 clause:
eu-nis2chapter-i/article-6 - distributor 12 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-14/7·chapter-iv/article-39/4;eu-ivdrchapter-i/section-1/article-2·chapter-ii/article-14/2·chapter-ii/article-14/4;eu-machinery-regulationchapter-i/article-3·chapter-v/article-30/4;eu-mdrchapter-i/article-2·chapter-ii/article-14/2·chapter-ii/article-14/4 - DNS 1 clause:
eu-nis2chapter-i/article-6 - DNS service provider 1 clause:
eu-nis2chapter-i/article-6 - domain name system 1 clause:
eu-nis2chapter-i/article-6 - downstream provider 1 clause:
eu-ai-actchapter-i/article-3 - Driver 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - Dynamic test 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - economic operator 8 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-ivdrannex-vi/part-a/1·chapter-i/section-1/article-2·chapter-vii/section-3/article-90/1;eu-machinery-regulationchapter-i/article-3;eu-mdrannex-vi/part-a/1·chapter-i/article-2·chapter-vii/section-3/article-95/1 - electronic communications service 1 clause:
eu-nis2chapter-i/article-6 - electronic information system 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - emotion recognition system 1 clause:
eu-ai-actchapter-i/article-3 - end-point 2 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-14/7 - end-to-end 1 clause:
fda-device-cybersecurity-20266 - entity 13 clauses:
ema-data-quality-framework10;eu-ai-actchapter-i/article-3;eu-gmp-annex-236;eu-ivdrchapter-vi/article-58/5;eu-mdrchapter-vi/article-62/4;eu-nis2chapter-i/article-6·chapter-v/article-26/3·chapter-v/article-26/4·chapter-v/article-27/2·chapter-vii/article-32/5·chapter-vii/article-32/6;fda-ai-guidance7;fda-device-cybersecurity-20266 - entity providing domain name registration services 1 clause:
eu-nis2chapter-i/article-6 - essential health and safety requirements 5 clauses:
eu-machinery-regulationannex-iii/part-b/5·annex-ix/3.3·annex-vii/6.2·annex-x/2·chapter-i/article-3 - ethics committee 6 clauses:
eu-ivdrannex-xiv/chapter-i/1·chapter-i/section-1/article-2·chapter-vi/article-58/5;eu-mdrannex-xv/chapter-ii/1·chapter-i/article-2·chapter-vi/article-62/4 - European standard 3 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - exploitable vulnerability 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - falsified device 6 clauses:
eu-ivdrchapter-i/section-1/article-2·chapter-ii/article-13/2·chapter-ii/article-14/2;eu-mdrchapter-i/article-2·chapter-ii/article-13/2·chapter-ii/article-14/2 - Federal Food, Drug, and Cosmetic Act 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - field safety corrective action 3 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrannex-vi/part-b·chapter-i/article-2 - 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 - free and open-source software 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - fully refurbishing 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - general-purpose AI model 5 clauses:
eu-ai-actchapter-i/article-3·chapter-ix/section-5/article-91/5·chapter-ix/section-5/article-92/5·chapter-v/section-2/article-54/1·chapter-v/section-2/article-54/3 - general-purpose AI system 1 clause:
eu-ai-actchapter-i/article-3 - generic device group 6 clauses:
eu-ivdrchapter-i/section-1/article-2·chapter-ii/article-11/2·chapter-v/section-2/article-48/7;eu-mdrchapter-i/article-2·chapter-ii/article-11/2·chapter-v/section-2/article-52/4 - guard 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - Guided load 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - hardware 8 clauses:
eu-ai-actchapter-iii/section-2/article-13/3;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrannex-i/chapter-iii;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-i/chapter-iii;fda-device-cybersecurity-20266;nist-ai-600-112;nistir-81837 - Harm 2 clauses:
fda-device-cybersecurity-20266;nist-ai-600-112 - harmonised standard 10 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actannex-viii/part-iv/3.3·chapter-i/article-3;eu-ivdrannex-ix/chapter-i/2.3·chapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·annex-ix/3.3·chapter-i/article-3;eu-mdrannex-ix/chapter-i/2.3·chapter-i/article-2 - Hazard / hazard 4 clauses:
eu-gmp-annex-1annex-1/11;eu-ivdrannex-i/chapter-iii;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - health institution 3 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrannex-xiii/1·chapter-i/article-2 - high-impact capabilities 1 clause:
eu-ai-actchapter-i/article-3 - ICT process 2 clauses:
eu-cybersecurity-acttitle-iv/article-69/4;eu-nis2chapter-i/article-6 - ICT product 2 clauses:
eu-cybersecurity-acttitle-iv/article-69/4;eu-nis2chapter-i/article-6 - ICT service 2 clauses:
eu-cybersecurity-acttitle-iv/article-69/4;eu-nis2chapter-i/article-6 - identity management 1 clause:
fda-device-cybersecurity-20266 - implantable device 1 clause:
eu-mdrchapter-i/article-2 - importer 25 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-23/2;eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-14/7·chapter-iv/article-39/4;eu-ivdrannex-vi/part-a/1·chapter-i/section-1/article-2·chapter-ii/article-13/2·chapter-ii/article-14/2·chapter-ii/article-14/4·chapter-ii/article-14/5·chapter-iii/article-27/1·chapter-iii/article-28/2·chapter-iii/article-28/8;eu-machinery-regulationchapter-i/article-3·chapter-v/article-30/4;eu-mdrannex-vi/part-a/1·chapter-i/article-2·chapter-ii/article-13/2·chapter-ii/article-14/2·chapter-ii/article-14/4·chapter-ii/article-14/5·chapter-iii/article-30/1·chapter-iii/article-31/2·chapter-iii/article-31/8 - 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-cyber-resilience-actchapter-i/article-3·chapter-ii/article-14/7;eu-gmp-annex-1annex-1/11;eu-gmp-annex-236;eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2;eu-mdrannex-i/chapter-iii·chapter-i/article-2;eu-nis2chapter-i/article-6;fda-device-cybersecurity-20266;nist-ai-600-112;nistir-81837 - incident handling 2 clauses:
eu-nis2chapter-i/article-6;nistir-81837 - indirect connection 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - informed consent 30 clauses:
eu-ai-actchapter-i/article-3·chapter-vi/article-60/4·chapter-vi/article-60/5·chapter-vi/article-61/1·chapter-vi/article-61/2;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-59/1·chapter-vi/article-59/2·chapter-vi/article-59/3·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·chapter-vi/article-62/5·chapter-vi/article-63/1·chapter-vi/article-63/2·chapter-vi/article-63/3·chapter-vi/article-63/7·chapter-vi/article-64/1·chapter-vi/article-65·chapter-vi/article-68/1·chapter-vi/article-68/2;fda-device-cybersecurity-20266;nist-ai-600-112 - input data 5 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-2/article-13/3·chapter-iii/section-3/article-26/4;ich-q1413.2;nist-ai-600-112 - instructions for use 17 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-2/article-13/3·chapter-iii/section-3/article-23/1·chapter-vi/article-60/4;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrannex-i/chapter-iii·annex-vi/part-b·annex-x/2·annex-xiii/part-a/2.3.2·chapter-i/section-1/article-2·chapter-ii/article-13/2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrannex-i/chapter-iii·annex-vi/part-b·chapter-i/article-2·chapter-ii/article-13/2 - intended purpose 19 clauses:
eu-ai-actannex-viii/13·chapter-i/article-3·chapter-iii/section-2/article-10/3·chapter-iii/section-2/article-13/3·chapter-iii/section-3/article-26/4·chapter-x/article-95/3;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrannex-i/chapter-iii·annex-ix/chapter-i/2.3·annex-x/2·annex-xiii/part-a/2.3.2·chapter-i/section-1/article-2·chapter-vi/article-58/5;eu-machinery-regulationchapter-i/article-3;eu-mdrannex-i/chapter-iii·annex-ix/chapter-i/2.3·chapter-i/article-2;ich-q1413.2;nist-ai-600-112 - intended use 10 clauses:
ema-data-quality-framework10;eu-gmp-annex-1annex-1/11;eu-gmp-annex-236;eu-gmp-annex-2210;eu-gmp-chapter-6part-1;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-xi/part-a;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-600-112 - interchangeable equipment 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - international standard 2 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-gmp-annex-1annex-1/11 - internet exchange point 1 clause:
eu-nis2chapter-i/article-6 - interventional clinical performance study 1 clause:
eu-ivdrchapter-i/section-1/article-2 - invasive device 1 clause:
eu-mdrchapter-i/article-2 - investigational device 3 clauses:
eu-mdrannex-xv/chapter-ii/1·chapter-i/article-2·chapter-vi/article-62/4 - investigator 14 clauses:
eu-gmp-annex-1311.1;eu-ivdrannex-xiii/part-a/2.3.2·annex-xiv/chapter-i/1·chapter-i/section-1/article-2·chapter-vi/article-60/1·chapter-vi/article-61/1·chapter-vi/article-64/1·chapter-vi/article-64/2;eu-mdrannex-xv/chapter-ii/1·chapter-i/article-2·chapter-vi/article-64/1·chapter-vi/article-65·chapter-vi/article-68/1·chapter-vi/article-68/2 - kit 2 clauses:
eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2 - label 10 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-chapter-6part-1;eu-ivdrannex-i/chapter-iii·annex-vi/part-b·annex-x/2·chapter-i/section-1/article-2;eu-mdrannex-i/chapter-iii·annex-vi/part-b·chapter-i/article-2;nist-ai-600-112 - large-scale cybersecurity incident 1 clause:
eu-nis2chapter-i/article-6 - law enforcement 3 clauses:
eu-ai-actchapter-i/article-3·chapter-vi/article-60/4;eu-digital-omnibus-aiarticle-1/6 - law enforcement authority 1 clause:
eu-ai-actchapter-i/article-3 - lay person 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - lifetime 7 clauses:
eu-ai-actchapter-iii/section-2/article-13/3;eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrannex-i/chapter-iii·chapter-i/article-2 - lifting accessory 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - Lifting operation 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - likelihood ratio 1 clause:
eu-ivdrchapter-i/section-1/article-2 - logical connection 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - machinery 13 clauses:
eu-ai-actchapter-xiii/article-113;eu-cyber-resilience-actchapter-viii/article-71/2;eu-machinery-regulationannex-iii/part-b/5·annex-ix/3.1·annex-ix/3.3·annex-vii/2·annex-vii/3·annex-vii/6.2·annex-x/2·chapter-i/article-3·chapter-ii/article-12/2·chapter-iii/article-24/3·chapter-v/article-30/4 - Machinery or related products for plant protection products application 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - Machinery or related products presenting risks due to their mobility 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - making available on the market 9 clauses:
eu-ai-actchapter-i/article-3·chapter-xiii/article-113;eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-14/7·chapter-viii/article-71/2;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrannex-i/chapter-iii·chapter-i/article-2 - managed security service provider 1 clause:
eu-nis2chapter-i/article-6 - managed service provider 1 clause:
eu-nis2chapter-i/article-6 - manufacturer 132 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actannex-v/2·annex-viii/part-i/5·annex-viii/part-ii/11·annex-viii/part-ii/3·annex-viii/part-iii/4·annex-viii/part-iv/3.1·annex-viii/part-iv/3.3·annex-viii/part-iv/8·chapter-i/article-3·chapter-ii/article-14/7·chapter-ii/article-18/1·chapter-ii/article-18/3·chapter-iii/article-30/4·chapter-iv/article-39/4;eu-cybersecurity-acttitle-iv/article-69/4;eu-gmp-annex-1annex-1/11;eu-gmp-annex-1311.1·11.3·5.2;eu-gmp-annex-175;eu-gmp-annex-236;eu-gmp-chapter-6part-1;eu-ivdrannex-i/chapter-iii·annex-iv/1·annex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-ix/chapter-i/2.3·annex-ix/chapter-i/3.2·annex-ix/chapter-iii·annex-vi/part-a/1·annex-vi/part-b·annex-vii/1.2.3·annex-vii/4.3·annex-vii/4.5.1·annex-x/2·annex-x/6·annex-xi/6·annex-xii/chapter-ii·annex-xiii/part-a/2.3.2·annex-xiv/chapter-i/1·chapter-i/section-1/article-2·chapter-ii/article-10/7·chapter-ii/article-11/1·chapter-ii/article-11/3·chapter-ii/article-11/5·chapter-ii/article-11/7·chapter-ii/article-12·chapter-ii/article-13/2·chapter-ii/article-13/6·chapter-ii/article-13/7·chapter-ii/article-13/8·chapter-ii/article-14/2·chapter-ii/article-14/4·chapter-ii/article-14/5·chapter-ii/article-14/6·chapter-iii/article-27/1·chapter-iii/article-27/3·chapter-iii/article-28/2·chapter-iii/article-28/8·chapter-v/section-1/article-47/2·chapter-v/section-2/article-48/7·chapter-v/section-2/article-48/9·chapter-v/section-2/article-55/1·chapter-vii/section-2/article-85·chapter-vii/section-3/article-90/1;eu-machinery-regulationannex-iii/part-b/5·annex-ix/3.1·annex-ix/3.3·annex-ix/8·annex-v/part-a/2·annex-v/part-b/2·annex-vi/5·annex-vii/10·annex-vii/3·annex-vii/6.2·annex-viii/4·annex-x/2·annex-x/6·chapter-i/article-3·chapter-ii/article-12/1·chapter-ii/article-12/2·chapter-iii/article-24/3·chapter-v/article-30/4;eu-mdrannex-i/chapter-iii·annex-iv/1·annex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-ix/chapter-i/2.3·annex-ix/chapter-i/3.2·annex-ix/chapter-iii·annex-vi/part-a/1·annex-vi/part-b·annex-vii/1.2.3·annex-vii/4.3·annex-vii/4.5.1·annex-x/2·annex-x/7·annex-xi/part-a·annex-xi/part-b·annex-xii/chapter-ii·annex-xiii/1·annex-xv/chapter-ii/1·chapter-i/article-2·chapter-ii/article-10/8·chapter-ii/article-11/1·chapter-ii/article-11/3·chapter-ii/article-11/5·chapter-ii/article-11/7·chapter-ii/article-12·chapter-ii/article-13/2·chapter-ii/article-13/6·chapter-ii/article-13/7·chapter-ii/article-13/8·chapter-ii/article-14/2·chapter-ii/article-14/4·chapter-ii/article-14/5·chapter-ii/article-14/6·chapter-iii/article-30/1·chapter-iii/article-30/3·chapter-iii/article-31/2·chapter-iii/article-31/8·chapter-v/section-1/article-51/2·chapter-v/section-2/article-52/4·chapter-v/section-2/article-52/6·chapter-v/section-2/article-60/1·chapter-vii/section-2/article-90·chapter-vii/section-3/article-95/1;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;nistir-81837 - market surveillance 20 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-22/3·chapter-iii/section-3/article-22/4·chapter-iii/section-3/article-23/2·chapter-ix/section-3/article-83/1·chapter-vi/article-60/4·chapter-xiii/article-113;eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-18/3·chapter-viii/article-71/2;eu-digital-omnibus-aiarticle-1/6;eu-ivdrannex-ix/chapter-i/2.1·annex-ix/chapter-i/3.2·chapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3·chapter-ii/article-12/2;eu-mdrannex-ix/chapter-i/2.1·annex-ix/chapter-i/3.2·annex-xi/part-b·chapter-i/article-2 - market surveillance authority 8 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-22/4·chapter-ix/section-3/article-83/1·chapter-vi/article-60/4;eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-18/3;eu-digital-omnibus-aiarticle-1/6;eu-machinery-regulationchapter-i/article-3 - medical device 8 clauses:
eu-ivdrannex-i/chapter-iii·annex-vi/part-b·chapter-i/section-1/article-2;eu-mdrannex-i/chapter-iii·annex-vi/part-b·chapter-i/article-2;fda-ai-guidance7;fda-device-cybersecurity-20266 - Metadata 2 clauses:
ema-data-quality-framework10;nist-ai-600-112 - nanomaterial 1 clause:
eu-mdrchapter-i/article-2 - national accreditation body 1 clause:
eu-machinery-regulationchapter-i/article-3 - national competent authority 3 clauses:
eu-ai-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/6;eu-gmp-annex-236 - national cybersecurity strategy 1 clause:
eu-nis2chapter-i/article-6 - near miss 2 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-nis2chapter-i/article-6 - negative predictive value 2 clauses:
eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2 - network and information system 1 clause:
eu-nis2chapter-i/article-6 - non-personal data 1 clause:
eu-ai-actchapter-i/article-3 - non-viable 3 clauses:
eu-gmp-annex-1annex-1/11;eu-mdrannex-xv/chapter-ii/1·chapter-i/article-2 - notified body 64 clauses:
eu-ai-actannex-vii/3.1·annex-vii/3.2·annex-vii/4.6·chapter-i/article-3·chapter-iii/section-3/article-22/3·chapter-iii/section-3/article-22/4·chapter-iii/section-5/article-48/4;eu-cyber-resilience-actannex-viii/part-ii/3·annex-viii/part-iv/3.1·annex-viii/part-iv/3.3·chapter-i/article-3·chapter-iii/article-30/4;eu-digital-omnibus-aiarticle-1/6;eu-ivdrannex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-ix/chapter-i/2.3·annex-ix/chapter-i/3.2·annex-ix/chapter-i/3.5·annex-ix/chapter-iii·annex-vii/1.2.3·annex-vii/4.3·annex-vii/4.5.1·annex-x/1·annex-x/2·annex-xi/6·annex-xii/chapter-ii·annex-xiv/chapter-i/1·chapter-i/section-1/article-2·chapter-ii/article-10/11·chapter-ii/article-11/6·chapter-ii/article-13/7·chapter-iv/article-41/2·chapter-v/section-1/article-47/2·chapter-v/section-2/article-48/7·chapter-v/section-2/article-55/1;eu-machinery-regulationannex-ix/3.1·annex-ix/3.3·annex-vii/3·annex-vii/6.2·annex-x/2·chapter-i/article-3·chapter-iii/article-24/3;eu-mdrannex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-ix/chapter-i/2.3·annex-ix/chapter-i/3.2·annex-ix/chapter-i/3.5·annex-ix/chapter-iii·annex-vii/1.2.3·annex-vii/4.3·annex-vii/4.5.1·annex-x/1·annex-x/2·annex-xi/part-a·annex-xi/part-b·annex-xii/chapter-ii·annex-xv/chapter-ii/1·chapter-i/article-2·chapter-ii/article-10/12·chapter-ii/article-11/6·chapter-ii/article-13/7·chapter-iv/article-45/2·chapter-v/section-1/article-51/2·chapter-v/section-2/article-60/1 - notifying authority 2 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3 - online marketplace 1 clause:
eu-nis2chapter-i/article-6 - online search engine 2 clauses:
eu-digital-omnibus-aiarticle-1/6;eu-nis2chapter-i/article-6 - open-source software steward 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - operator 17 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/6;eu-gmp-annex-1annex-1/11;eu-gmp-annex-236;eu-gmp-annex-2210;eu-ivdrannex-vi/part-a/1·chapter-i/section-1/article-2·chapter-vii/section-3/article-90/1;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrannex-vi/part-a/1·chapter-i/article-2·chapter-vii/section-3/article-95/1;fda-device-cybersecurity-20266;nist-ai-600-112;nistir-81837 - particle 3 clauses:
eu-gmp-annex-1annex-1/11;eu-mdrchapter-i/article-2;ich-q1413.2 - partly completed machinery 4 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3·chapter-ii/article-12/2·chapter-v/article-30/4 - performance 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 - performance evaluation 5 clauses:
eu-ivdrannex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-vii/4.5.1·annex-xiv/chapter-i/1·chapter-i/section-1/article-2 - performance of a device 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - performance of an AI system 1 clause:
eu-ai-actchapter-i/article-3 - performance study 16 clauses:
eu-ivdrannex-i/chapter-iii·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 - performance study plan 5 clauses:
eu-ivdrannex-xiii/part-a/2.3.2·annex-xiv/chapter-i/1·chapter-i/section-1/article-2·chapter-vi/article-58/5·chapter-vi/article-64/1 - personal data 8 clauses:
eu-ai-actchapter-i/article-3·chapter-vi/article-60/4·chapter-vi/article-60/5·chapter-xiii/article-113;eu-cyber-resilience-actchapter-i/article-3·chapter-viii/article-71/2;eu-digital-omnibus-aiarticle-1/6;nist-ai-600-112 - physical connection 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - placing on the market 12 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-5/article-49/1·chapter-iii/section-5/article-49/2;eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-14/7;eu-digital-omnibus-aiarticle-1/6;eu-ivdrannex-xii/chapter-ii·chapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrannex-xii/chapter-ii·chapter-i/article-2 - positive predictive value 1 clause:
eu-ivdrchapter-i/section-1/article-2 - post-market monitoring system 2 clauses:
eu-ai-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/6 - post-market surveillance 7 clauses:
eu-ivdrannex-ix/chapter-i/2.1·annex-ix/chapter-i/3.2·chapter-i/section-1/article-2;eu-mdrannex-ix/chapter-i/2.1·annex-ix/chapter-i/3.2·annex-xi/part-b·chapter-i/article-2 - post-remote biometric identification system 1 clause:
eu-ai-actchapter-i/article-3 - predictive value 2 clauses:
eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2 - procedure pack 1 clause:
eu-mdrchapter-i/article-2 - Product Lifecycle 3 clauses:
fda-ai-guidance7;ich-q124;ich-q1413.2 - product with digital elements 5 clauses:
eu-cyber-resilience-actannex-viii/part-ii/3·annex-viii/part-iv/3.3·chapter-i/article-3·chapter-ii/article-14/7·chapter-ii/article-18/3 - professional user 2 clauses:
eu-machinery-regulationchapter-i/article-3;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 33 clauses:
ema-data-quality-framework10;eu-ai-actannex-v/2·annex-vii/3.1·annex-vii/3.2·annex-vii/4.6·annex-viii/13·chapter-i/article-3·chapter-iii/section-2/article-13/3·chapter-iii/section-3/article-18/2·chapter-iii/section-3/article-22/2·chapter-iii/section-3/article-22/3·chapter-iii/section-3/article-22/4·chapter-iii/section-3/article-23/1·chapter-iii/section-3/article-23/2·chapter-iii/section-5/article-48/4·chapter-iii/section-5/article-49/1·chapter-iii/section-5/article-49/2·chapter-ix/section-3/article-83/1·chapter-ix/section-5/article-91/5·chapter-ix/section-5/article-92/5·chapter-v/section-2/article-54/2·chapter-v/section-2/article-54/3·chapter-v/section-2/article-54/4·chapter-v/section-2/article-54/5·chapter-vi/article-60/4·chapter-vi/article-61/1·chapter-viii/article-71/2;eu-digital-omnibus-aiarticle-1/6;eu-gmp-annex-2210;eu-nis2chapter-i/article-6;fda-device-cybersecurity-20266;nist-ai-600-112;nistir-81837 - public administration entity 1 clause:
eu-nis2chapter-i/article-6 - public electronic communications network 1 clause:
eu-nis2chapter-i/article-6 - publicly accessible space 1 clause:
eu-ai-actchapter-i/article-3 - putting into service 8 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-5/article-49/1·chapter-iii/section-5/article-49/2;eu-digital-omnibus-aiarticle-1/6;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrchapter-i/article-2 - qualified trust service 1 clause:
eu-nis2chapter-i/article-6 - qualified trust service provider 1 clause:
eu-nis2chapter-i/article-6 - Quality 14 clauses:
ema-data-quality-framework10;eu-gmp-annex-1annex-1/11;eu-gmp-annex-161.5.6·1.5.7;eu-gmp-annex-175;eu-gmp-annex-236;eu-gmp-annex-2210;eu-gmp-chapter-6part-1;eu-mdrannex-xi/part-a;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;ich-q1413.2;nistir-81837 - Quality Risk Management 7 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-161.5.6·1.5.7;eu-gmp-annex-2210;fda-ai-guidance7;ich-q124;ich-q1413.2 - Quality System 7 clauses:
ema-data-quality-framework10;eu-gmp-annex-1annex-1/11;eu-gmp-annex-175;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;ich-q1413.2 - real-time remote biometric identification system 1 clause:
eu-ai-actchapter-i/article-3 - real-world testing plan 3 clauses:
eu-ai-actchapter-i/article-3·chapter-vi/article-60/4;eu-digital-omnibus-aiarticle-1/6 - reasonably foreseeable misuse 5 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-2/article-13/3;eu-cyber-resilience-actchapter-i/article-3;eu-machinery-regulationannex-iii/part-b/5;fda-device-cybersecurity-20266 - reasonably foreseeable use 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - recall 19 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-20/1;eu-cyber-resilience-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/6;eu-gmp-annex-1311.1;eu-gmp-annex-236;eu-ivdrchapter-i/section-1/article-2·chapter-ii/article-10/11·chapter-ii/article-13/7·chapter-ii/article-14/4·chapter-vii/section-3/article-90/1;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2·chapter-ii/article-10/12·chapter-ii/article-13/7·chapter-ii/article-14/4·chapter-vii/section-3/article-95/1;fda-ai-guidance7;fda-device-cybersecurity-20266 - 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 - remote data processing 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - removable mechanical transmission device 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - reprocessing 3 clauses:
eu-gmp-chapter-6part-1;eu-mdrannex-i/chapter-iii·chapter-i/article-2 - Requirements 6 clauses:
ema-data-quality-framework10;eu-gmp-annex-1annex-1/11;eu-machinery-regulationannex-iii/part-b/5;fda-device-cybersecurity-20266;ich-q124;nistir-81837 - research organisation 1 clause:
eu-nis2chapter-i/article-6 - Risk / risk 71 clauses:
eu-ai-actannex-viii/13·chapter-i/article-3·chapter-iii/section-2/article-10/3·chapter-iii/section-2/article-13/3·chapter-iii/section-3/article-20/1·chapter-iii/section-3/article-22/1·chapter-iii/section-3/article-22/3·chapter-iii/section-3/article-23/1·chapter-iii/section-3/article-23/2·chapter-iii/section-3/article-26/4·chapter-iii/section-5/article-48/4·chapter-iii/section-5/article-49/1·chapter-iii/section-5/article-49/2·chapter-vi/article-60/4;eu-cyber-resilience-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/6;eu-gmp-annex-1annex-1/11;eu-gmp-annex-161.5.6·1.5.7;eu-gmp-annex-175;eu-gmp-annex-236;eu-gmp-annex-2210;eu-gmp-chapter-6part-1;eu-ivdrannex-i/chapter-iii·annex-ix/chapter-i/2.2·annex-ix/chapter-i/3.2·annex-vi/part-b·annex-vii/4.5.1·chapter-i/section-1/article-2·chapter-ii/article-10/11·chapter-ii/article-13/2·chapter-ii/article-13/7·chapter-ii/article-14/2·chapter-ii/article-14/4·chapter-iv/article-41/2·chapter-v/section-2/article-48/13·chapter-vi/article-58/5·chapter-vi/article-60/1·chapter-vi/article-61/1·chapter-vi/article-64/1·chapter-vii/section-2/article-85·chapter-vii/section-3/article-90/1;eu-machinery-regulationannex-iii/part-b/5·annex-x/2·chapter-i/article-3;eu-mdrannex-i/chapter-iii·annex-ix/chapter-i/2.2·annex-ix/chapter-i/3.2·annex-vi/part-b·annex-vii/4.5.1·chapter-i/article-2·chapter-ii/article-10/12·chapter-ii/article-13/2·chapter-ii/article-13/7·chapter-ii/article-14/2·chapter-ii/article-14/4·chapter-iv/article-45/2·chapter-v/section-2/article-52/14·chapter-vi/article-62/4·chapter-vi/article-68/1·chapter-vii/section-2/article-90·chapter-vii/section-3/article-95/1;eu-nis2chapter-i/article-6;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;ich-q1413.2;ich-q2r2annex-2/2.2;nist-ai-600-112;nist-ai-rmf3.7;nistir-81837 - Risk Assessment 3 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266;nistir-81837 - Risk Management 10 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-161.5.6·1.5.7;eu-gmp-annex-2210;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;ich-q1413.2;nist-ai-600-112;nistir-81837 - ropes 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - safety component 2 clauses:
eu-ai-actchapter-i/article-3;eu-machinery-regulationchapter-i/article-3 - safety function 3 clauses:
eu-ai-actchapter-i/article-3;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - sandbox plan 2 clauses:
eu-ai-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/6 - scientific validity of an analyte 1 clause:
eu-ivdrchapter-i/section-1/article-2 - security of network and information systems 1 clause:
eu-nis2chapter-i/article-6 - sensitive operational data 1 clause:
eu-ai-actchapter-i/article-3 - serious adverse event 3 clauses:
eu-gmp-annex-236;eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - serious incident 5 clauses:
eu-ai-actchapter-i/article-3;eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2;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 cyber threat 1 clause:
eu-nis2chapter-i/article-6 - significant cybersecurity risk 2 clauses:
eu-cyber-resilience-actchapter-i/article-3;fda-device-cybersecurity-20266 - single-use device 4 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrannex-i/chapter-iii·annex-vi/part-b·chapter-i/article-2 - SME 1 clause:
eu-gmp-annex-2210 - social networking services platform 1 clause:
eu-nis2chapter-i/article-6 - software 14 clauses:
ema-data-quality-framework10;eu-ai-actchapter-iii/section-2/article-13/3;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrannex-i/chapter-iii·chapter-i/article-2;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q1413.2;nist-ai-600-112;nistir-81837 - software bill of materials 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - source code 3 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-machinery-regulationchapter-i/article-3;fda-device-cybersecurity-20266 - special categories of personal data 1 clause:
eu-ai-actchapter-i/article-3 - specimen receptacle 1 clause:
eu-ivdrchapter-i/section-1/article-2 - sponsor 17 clauses:
eu-gmp-annex-1311.1·11.3·5.2·6.3;eu-ivdrannex-xiii/part-a/2.3.2·annex-xiv/chapter-i/1·chapter-i/section-1/article-2·chapter-vi/article-58/4·chapter-vi/article-58/5;eu-mdrannex-xv/chapter-ii/1·annex-xv/chapter-ii/3.1.2·annex-xv/chapter-iii/3·chapter-i/article-2·chapter-vi/article-62/2·chapter-vi/article-62/4;fda-ai-guidance7;fda-device-cybersecurity-20266 - Stakeholder 1 clause:
nist-ai-600-112 - standard 23 clauses:
ema-data-quality-framework10;eu-ai-actchapter-i/article-3;eu-cyber-resilience-actannex-viii/part-iv/3.3·chapter-i/article-3;eu-gmp-annex-1annex-1/11;eu-gmp-chapter-6part-1;eu-ivdrannex-ix/chapter-i/2.3·chapter-i/section-1/article-2·chapter-vi/article-60/1·chapter-vi/article-61/1·chapter-vi/article-64/1;eu-machinery-regulationannex-iii/part-b/5·annex-ix/3.3·chapter-i/article-3;eu-mdrannex-ix/chapter-i/2.3·annex-xi/part-b·chapter-i/article-2·chapter-vi/article-68/1;eu-nis2chapter-i/article-6;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q1413.2;nist-ai-600-112 - Static test 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - subject 52 clauses:
ema-data-quality-framework10;eu-ai-actchapter-i/article-3·chapter-vi/article-60/4·chapter-vi/article-61/1;eu-cyber-resilience-actchapter-i/article-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-ivdrchapter-i/section-1/article-2·chapter-iv/article-35/3·chapter-v/section-2/article-48/7·chapter-v/section-2/article-48/9·chapter-vi/article-58/5·chapter-vi/article-58/6·chapter-vi/article-59/1·chapter-vi/article-59/2·chapter-vi/article-59/3·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·chapter-vii/section-3/article-90/1;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-xi/part-a·annex-xi/part-b·annex-xv/chapter-ii/1·chapter-i/article-2·chapter-iv/article-39/3·chapter-v/section-2/article-52/4·chapter-v/section-2/article-52/6·chapter-vi/article-62/4·chapter-vi/article-62/5·chapter-vi/article-63/1·chapter-vi/article-63/2·chapter-vi/article-63/3·chapter-vi/article-64/1·chapter-vi/article-65·chapter-vi/article-68/1·chapter-vi/article-68/2·chapter-vi/article-68/3·chapter-vii/section-3/article-95/1;eu-nis2chapter-i/article-6·chapter-vii/article-32/5;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;ich-q1413.2;nist-ai-600-112 - substantial modification 3 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-machinery-regulationchapter-i/article-3 - Supervisor 4 clauses:
eu-ai-actchapter-i/article-3·chapter-vii/section-1/article-65/2;eu-digital-omnibus-aiarticle-1/6;eu-machinery-regulationannex-iii/part-b/5 - Supervisory function 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - support period 2 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-18/3 - System / system 69 clauses:
ema-data-quality-framework10;eu-ai-actannex-vii/3.1·annex-vii/3.2·annex-vii/4.6·annex-viii/13·chapter-i/article-3·chapter-iii/section-2/article-10/3·chapter-iii/section-2/article-13/3·chapter-iii/section-3/article-20/1·chapter-iii/section-3/article-22/3·chapter-iii/section-3/article-23/1·chapter-iii/section-3/article-23/2·chapter-iii/section-3/article-26/4·chapter-iii/section-5/article-48/4·chapter-iii/section-5/article-49/1·chapter-iii/section-5/article-49/2·chapter-vi/article-60/4·chapter-vi/article-61/1·chapter-xiii/article-113;eu-cyber-resilience-actannex-viii/part-iv/3.1·annex-viii/part-iv/3.3·chapter-i/article-3;eu-digital-omnibus-aiarticle-1/6;eu-gmp-annex-1annex-1/11;eu-gmp-annex-161.5.5;eu-gmp-annex-175;eu-gmp-annex-236;eu-gmp-annex-2210;eu-gmp-chapter-6part-1;eu-ivdrannex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-ix/chapter-i/2.3·annex-ix/chapter-i/3.2·annex-vii/4.3·annex-vii/4.5.1·chapter-i/section-1/article-2·chapter-iii/article-27/1·chapter-iii/article-27/3·chapter-iii/article-28/2·chapter-vi/article-59/2·chapter-vii/section-2/article-85;eu-machinery-regulationannex-iii/part-b/5·annex-ix/3.1·annex-ix/3.3·annex-x/2·chapter-i/article-3;eu-mdrannex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-ix/chapter-i/2.3·annex-ix/chapter-i/3.2·annex-vii/4.3·annex-vii/4.5.1·annex-xi/part-a·annex-xi/part-b·chapter-i/article-2·chapter-iii/article-30/1·chapter-iii/article-30/3·chapter-iii/article-31/2·chapter-vi/article-63/2·chapter-vii/section-2/article-90;eu-nis2chapter-i/article-6;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;ich-q1413.2;nist-ai-600-112·6;nist-ai-rmf3.7;nistir-81837 - systemic risk 1 clause:
eu-ai-actchapter-i/article-3 - technical specification 2 clauses:
eu-cyber-resilience-actannex-viii/part-iv/3.3;eu-nis2chapter-i/article-6 - technical specifications 4 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actannex-viii/part-ii/3;eu-machinery-regulationannex-vii/6.2·chapter-i/article-3 - Test coefficient 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - testing data 4 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-2/article-10/3·chapter-iii/section-2/article-13/3;eu-gmp-annex-1annex-1/11 - testing in real-world conditions 3 clauses:
eu-ai-actchapter-i/article-3·chapter-vi/article-60/4;eu-digital-omnibus-aiarticle-1/6 - TLD name registry 1 clause:
eu-nis2chapter-i/article-6 - top-level domain name registry 1 clause:
eu-nis2chapter-i/article-6 - training data 5 clauses:
eu-ai-actchapter-i/article-3;eu-gmp-annex-2210;fda-ai-guidance7;nist-ai-600-112·6 - Trend 1 clause:
eu-gmp-chapter-6part-1 - trust service 1 clause:
eu-nis2chapter-i/article-6 - trust service provider 1 clause:
eu-nis2chapter-i/article-6 - UDI 13 clauses:
eu-ivdrannex-i/chapter-iii·annex-vi/part-b·chapter-i/section-1/article-2·chapter-ii/article-13/2·chapter-ii/article-14/2·chapter-v/section-2/article-55/1;eu-mdrannex-i/chapter-iii·annex-vi/part-b·chapter-i/article-2·chapter-ii/article-13/2·chapter-ii/article-14/2·chapter-v/section-2/article-60/1;fda-device-cybersecurity-20266 - Union harmonisation legislation 7 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/6;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrchapter-i/article-2 - 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 19 clauses:
eu-cyber-resilience-actchapter-iv/article-39/4;eu-cybersecurity-acttitle-iv/article-69/4;eu-gmp-annex-1annex-1/11;eu-gmp-annex-2210;eu-ivdrannex-i/chapter-iii·annex-xiii/part-a/2.3.2·chapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·annex-vii/3·chapter-i/article-3·chapter-v/article-30/4;eu-mdrannex-i/chapter-iii·annex-xiii/1·chapter-i/article-2;eu-nis2chapter-i/article-6;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-600-112;nistir-81837 - validation data 3 clauses:
eu-ai-actchapter-i/article-3;ich-q124;ich-q1413.2 - validation data set 1 clause:
eu-ai-actchapter-i/article-3 - vulnerability 7 clauses:
eu-cyber-resilience-actannex-viii/part-ii/3·chapter-i/article-3·chapter-ii/article-14/7;eu-nis2chapter-i/article-6;fda-device-cybersecurity-20266;nist-ai-600-112;nistir-81837 - webbing 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - widespread infringement 1 clause:
eu-ai-actchapter-i/article-3 - withdrawal 8 clauses:
eu-ai-actchapter-i/article-3·chapter-vi/article-60/5;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2·chapter-vi/article-58/6;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2·chapter-vi/article-62/5 - 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 37 clauses:
eu-ai-actannex-vii/3.1·chapter-i/article-3·chapter-iii/section-3/article-22/1·chapter-v/section-2/article-54/1;eu-cyber-resilience-actannex-viii/part-ii/3·annex-viii/part-iv/3.1·chapter-i/article-3·chapter-ii/article-18/1;eu-digital-omnibus-aiarticle-1/6;eu-gmp-annex-1annex-1/11;eu-gmp-annex-1311.3;eu-gmp-annex-161.5.5;eu-gmp-annex-236;eu-gmp-chapter-6part-1;eu-ivdrannex-i/chapter-iii·annex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-vii/4.3·annex-x/2·chapter-i/section-1/article-2·chapter-vi/article-59/1;eu-machinery-regulationannex-iii/part-b/5·annex-ix/3.1·annex-vii/3·annex-x/2·chapter-i/article-3·chapter-ii/article-12/1;eu-mdrannex-i/chapter-iii·annex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-vii/4.3·annex-x/2·annex-xi/part-a·chapter-i/article-2·chapter-vi/article-63/1;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 | 1 |
| 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 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
58dbc3006d27 | 0 | 39 | 5 | |
9d16077b1d3b (current) | 0 | 39 | 5 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
9206a43954eb (current) | 0 | 21 | 3 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
1fe6027daa2c (current) | 0 | 2 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
92eb86f25281 (current) | 0 | 3 | 0 |
| 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 | 18 | 2 |
| 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 | 2 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
48f21f2e4f1b unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
c4635c9c95ba (current) | 0 | 3 | 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 | 1 | 0 |
| 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 | 1 | 3 |
| 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 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
4aafde337ab3 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
fecd3a76fef8 (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
053f731102ad unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
c1a1d8a7fee4 (current) | 0 | 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 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
04e1593f805c unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
1be3d183419f (current) | 0 | 2 | 1 |
| 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 |
|---|---|---|---|---|
903e40aaebe6 (current) | 0 | 82 | 8 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
1fc20ae2ffd8 | 0 | 27 | 2 | |
82fb682a6c54 (current) | 0 | 27 | 2 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
14d00b77d5c8 | 0 | 90 | 7 | |
fab624c8e1dc (current) | 0 | 90 | 7 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
023dc18395dc (current) | 1 | 13 | 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 | 3 | 4 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
b52b706d5cca (current) | 0 | 0 | 0 | |
d34d8c706d88 | 0 | 1 | 0 |
| 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 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
206fc2d61445 (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
06273204f50b (current) | 0 | 4 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
5e9388123e17 (current) | 0 | 1 | 6 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
bb656b9e84a8 (current) | 0 | 2 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
a5ad5867c187 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
caa03fc84948 (current) | 0 | 1 | 7 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
8afebcc0941a | 0 | 0 | 0 | |
c240f2675bd3 | 0 | 0 | 0 | |
4c10dc03228b (current) | 0 | 0 | 1 |
| 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 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
393b48f902b8 | 0 | 8 | 0 | |
5997ebbb6661 | 0 | 8 | 0 | |
9d7b6d9aa4e1 | 0 | 8 | 0 | |
18e04a0c925a | 0 | 8 | 0 | |
1e7f13684129 | 0 | 8 | 0 | |
f24b92ecdf42 | 0 | 8 | 0 | |
b670ac9656b7 | 0 | 8 | 0 | |
bc527e48bcd8 | 0 | 8 | 0 | |
4edb9480421c | 0 | 8 | 0 | |
cd3e1c0c936b | 0 | 8 | 0 | |
75605421c92f (current) | 0 | 8 | 0 |
Feed
/atom/term/representative.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 NIS2 Directive | true | open | true | true |
| 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 Cyber Resilience Act | true | open | true | true |
| EU AI Act | true | open | true | true |
| EU GMP Annex 22 | true | open | true | true |
| FDA device cybersecurity | true | open | true | true |
| FDA device cybersecurity (2026) | true | open | true | true |
| EU GMP Annex 11 | true | open | true | true |
| 21 CFR Part 820 (QMSR) | true | open | true | true |
| ICH Q9(R1) | true | open | true | true |
| FDA electronic systems (clinical) | 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: