written
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 GMP Chapter 4no clause given: text withheld (end not delimited: no definition is read after it in this text)
- Rows printing it in a normative sentence
- 28
- Rows printing it in a title
- 0
- Rows printing it in body
- 9
International
- Defined in
- no current text of a row of this jurisdiction defines it
- Rows printing it in a normative sentence
- 0
- Rows printing it in a title
- 0
- Rows printing it in body
- 1
US
- Defined in
- no current text of a row of this jurisdiction defines it
- Rows printing it in a normative sentence
- 14
- Rows printing it in a title
- 0
- Rows printing it in body
- 5
This form is printed by the
tracked documents, each as a document defines it. The index’s key is
written (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 GMP Chapter 4
EUtext first observed- no clause given (no numbering read in this text) written: text withheld (end not delimited: no definition is read after it in this text)
In normative sentences
193 sentences in 42 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
EU2 sentences; text first observedid repeats in this text: 2 sentences (should) - EU AI Act
EU14 sentences; text first observedno clause anchor before this sentence: 2 sentences (should) ·chapter-i/article-3: 1 sentence (may, shall) ·chapter-iii/section-3/article-17/1: 1 sentence (shall) ·chapter-iii/section-3/article-22/1: 1 sentence (shall) ·chapter-iii/section-3/article-25/4: 1 sentence (shall) ·chapter-iii/section-5/article-47/1: 1 sentence (shall) ·chapter-v/section-2/article-54/1: 1 sentence (shall) ·chapter-vi/article-57/7: 2 sentences (shall) ·chapter-vii/section-1/article-66: 1 sentence (may) ·chapter-vii/section-1/article-67/8: 1 sentence (may) ·annex-vii/3.1: 1 sentence (shall) ·annex-vii/4.2: 1 sentence (shall) - EU Cyber Resilience Act
EU9 sentences; text first observedchapter-i/article-3: 1 sentence (may) ·chapter-ii/article-18/1: 1 sentence (may) ·chapter-vi/article-62/3: 1 sentence (shall) ·annex-viii/part-i/4.2: 1 sentence (shall) ·annex-viii/part-ii/3: 1 sentence (shall) ·annex-viii/part-iii/3.2: 1 sentence (shall) ·annex-viii/part-iv/3.1: 1 sentence (shall) ·annex-viii/part-iv/3.2: 1 sentence (shall) ·annex-viii/part-iv/5.2: 1 sentence (shall) - EU Cybersecurity Act
EU1 sentence; text first observedtitle-iv/article-69/9: 1 sentence (shall) - Regulation (EU) 2026/1744
EU2 sentences; text first observedarticle-1/4: 1 sentence (shall) ·article-1/6: 1 sentence (shall) - EU GMP Annex 1
EU6 sentences; text first observedannex-1/11: 6 sentences (should) - EU GMP Annex 11 (draft)
EU1 sentence; text first observed17: 1 sentence (should) - EU GMP Annex 13
EU9 sentences; text first observed2: 1 sentence (should, may) ·5.1: 1 sentence (should) ·5.3: 2 sentences (should) ·6.2: 1 sentence (shall, should) ·7: 1 sentence (should, may) ·9: 1 sentence (should) ·10: 1 sentence (should) ·11.3: 1 sentence (should) - EU GMP Annex 14
EU7 sentences; text first observed10: 7 sentences (should, may, must) - EU GMP Annex 16
EU4 sentences; text first observedno clause anchor before this sentence: 1 sentence (should) ·1.4.1: 1 sentence (must) ·1.5.5: 1 sentence (should) ·2.2: 1 sentence (should) - EU GMP Annex 19
EU6 sentences; text first observed6.1: 2 sentences (should) ·6.2: 1 sentence (should) ·7.2: 2 sentences (should) ·8.4: 1 sentence (should) - EU GMP Annex 2
EU1 sentence; text first observed36: 1 sentence (must, may) - EU GMP Annex 21
EU1 sentence; text first observed5.1: 1 sentence (should) - EU GMP Annex 3
EU2 sentences; text first observed29: 1 sentence (should) ·43: 1 sentence (should) - EU GMP Annex 7
EU1 sentence; text first observed10: 1 sentence (should) - EU GMP Annex 8
EU1 sentence; text first observed1: 1 sentence (should) - EU GMP Chapter 2
EU1 sentence; text first observedpart-1: 1 sentence (should, must) - EU GMP Chapter 3
EU3 sentences; text first observedpart-1: 3 sentences (should) - EU GMP Chapter 4
EU7 sentences; text first observedno numbering read: 7 sentences (may, should) - EU GMP Chapter 4 (draft)
EU7 sentences; text first observedno numbering read: 7 sentences (should) - EU GMP Chapter 5
EU3 sentences; text first observedpart-1: 3 sentences (should, may) - EU GMP Chapter 6
EU6 sentences; text first observedpart-1: 6 sentences (should) - EU GMP Chapter 7
EU2 sentences; text first observedno numbering read: 2 sentences (must, should) - EU GMP Chapter 8
EU2 sentences; text first observedpart-1: 2 sentences (should) - EU IVDR
EU14 sentences; text first observedno clause anchor before this sentence: 1 sentence (should) ·chapter-iii/article-29/1: 1 sentence (shall) ·chapter-iv/article-38/6: 1 sentence (may) ·chapter-iv/article-38/8: 1 sentence (shall) ·chapter-iv/article-42/6: 1 sentence (shall) ·chapter-vi/article-59/1: 1 sentence (shall) ·annex-i/chapter-iii: 1 sentence (shall) ·annex-vii/2.4: 1 sentence (shall) ·annex-vii/3.4.2: 1 sentence (shall) ·annex-vii/4.3: 1 sentence (shall) ·annex-ix/chapter-i/2.1: 1 sentence (shall) ·annex-ix/chapter-i/2.2: 1 sentence (shall) ·annex-x/2: 1 sentence (shall) ·annex-xi/3.2: 1 sentence (shall) - EU Machinery Regulation
EU9 sentences; text first observedchapter-i/article-3: 1 sentence (may) ·chapter-ii/article-12/1: 1 sentence (may) ·annex-iii/part-b/5: 1 sentence (must) ·annex-vii/3: 1 sentence (shall) ·annex-ix/3.1: 1 sentence (shall) ·annex-ix/3.2: 1 sentence (shall) ·annex-ix/5.2: 1 sentence (shall) ·annex-x/2: 1 sentence (shall) ·annex-x/5.2: 1 sentence (shall) - EU MDR
EU20 sentences; text first observedno clause anchor before this sentence: 1 sentence (should) ·chapter-i/article-2: 3 sentences (shall, may) ·chapter-ii/article-18/1: 1 sentence (shall) ·chapter-iii/article-32/1: 1 sentence (shall) ·chapter-iv/article-42/6: 1 sentence (may) ·chapter-iv/article-42/8: 1 sentence (shall) ·chapter-iv/article-46/8: 1 sentence (shall) ·chapter-vi/article-63/1: 1 sentence (shall) ·chapter-viii/article-103/6: 1 sentence (may) ·annex-i/chapter-iii: 1 sentence (shall) ·annex-vii/2.4: 1 sentence (shall) ·annex-vii/3.4.2: 1 sentence (shall) ·annex-vii/4.3: 1 sentence (shall) ·annex-ix/chapter-i/2.1: 1 sentence (shall) ·annex-ix/chapter-i/2.2: 1 sentence (shall) ·annex-ix/chapter-ii: 1 sentence (shall) ·annex-x/2: 1 sentence (may) ·annex-xi/part-a: 1 sentence (shall) - EU NIS2 Directive
EU2 sentences; text first observedno clause anchor before this sentence: 1 sentence (should) ·chapter-viii/article-39/3: 1 sentence (shall) - FDA CDRH AI/ML
US1 sentence; text first observedno numbering read: 1 sentence (should) - FDA clinical decision support
US1 sentence; text first observedno numbering read: 1 sentence (should) - FDA CSA
US1 sentence; text first observedno numbering read: 1 sentence (should) - FDA data integrity
US1 sentence; text first observedno numbering read: 1 sentence (should) - FDA device cybersecurity
US1 sentence; text first observedno numbering read: 1 sentence (should) - FDA electronic systems (clinical)
US1 sentence; text first observedno clause anchor before this sentence: 1 sentence (should) - FDA Part 11 scope
US1 sentence; text first observedno numbering read: 1 sentence (should) - FDA PCCP
US1 sentence; text first observedno numbering read: 1 sentence (should) - FDA postmarket cybersecurity
US1 sentence; text first observedno numbering read: 1 sentence (should) - FDA process analytical framework
US1 sentence; text first observedno numbering read: 1 sentence (should) - FDA software validation
US1 sentence; text first observedno numbering read: 1 sentence (should) - NIST AI 600-1
US1 sentence; text first observed3: 1 sentence (may) - 21 CFR Part 11
US1 sentence; text first observedno numbering read: 1 sentence (shall) - 21 CFR Part 211
US37 sentences; text first observedno numbering read: 37 sentences (shall, may, must)
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
17 occurrences in 15 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
EU2 occurrences; text first observed2 where the heading before it is withheld - EU AI Act
EU1 occurrence; text first observed1 where no heading is read before it - EU GMP Annex 11
EU1 occurrence; text first observed14: 1 - EU GMP Annex 19
EU1 occurrence; text first observed6.3: 1 - EU GMP Chapter 1
EU1 occurrence; text first observedchapter-1: 1 - EU GMP Chapter 2
EU1 occurrence; text first observedpart-1: 1 - EU GMP Chapter 4 (draft)
EU1 occurrence; text first observed1 where no numbering read in this text - EU IVDR
EU2 occurrences; text first observedchapter-i/section-1/article-2: 2 - EU MDR
EU1 occurrence; text first observedchapter-i/article-2: 1 - FDA AI guidance
US1 occurrence; text first observed1 where no heading is read before it - FDA device cybersecurity (2026)
US1 occurrence; text first observed1 where no heading is read before it - FDA electronic systems (clinical)
US1 occurrence; text first observed1 where no heading is read before it - FDA Part 11 scope
US1 occurrence; text first observed1 where no numbering read in this text - ICH Q12
International1 occurrence; text first observed4: 1 - NIST AI 600-1
US1 occurrence; text first observed12: 1
Co-occurrence
227 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. 82 positions of this term have no placed clause and share none (a defining occurrence inside a sentence above is counted once under each).
- accessory for a medical device 1 clause:
eu-mdrchapter-i/article-2 - accessory for an in vitro diagnostic medical device 1 clause:
eu-ivdrchapter-i/section-1/article-2 - accreditation 1 clause:
eu-machinery-regulationchapter-i/article-3 - Act 1 clause:
ich-q124 - active device 1 clause:
eu-mdrchapter-i/article-2 - actively exploited vulnerability 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - adverse event 5 clauses:
eu-gmp-annex-1410;eu-gmp-annex-236;eu-gmp-chapter-8part-1;eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - Agency 3 clauses:
eu-gmp-annex-1410;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 2 clauses:
eu-ai-actchapter-i/article-3·chapter-vii/section-1/article-66 - AI Office 4 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-25/4·chapter-vii/section-1/article-66;eu-digital-omnibus-aiarticle-1/6 - AI regulatory sandbox 3 clauses:
eu-ai-actchapter-i/article-3·chapter-vi/article-57/7;eu-digital-omnibus-aiarticle-1/6 - AI system 10 clauses:
eu-ai-actannex-vii/3.1·chapter-i/article-3·chapter-iii/section-3/article-17/1·chapter-iii/section-3/article-25/4·chapter-iii/section-5/article-47/1·chapter-vi/article-57/7;eu-digital-omnibus-aiarticle-1/4·article-1/6;nist-ai-600-112·3 - analytical performance 2 clauses:
eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2 - Application 8 clauses:
eu-ivdrannex-vii/4.3·annex-x/2;eu-machinery-regulationannex-iii/part-b/5·annex-vii/3;eu-mdrannex-vii/4.3·annex-x/2·annex-xi/part-a;ich-q124 - assurance level 1 clause:
eu-gmp-annex-1annex-1/11 - Audits 1 clause:
eu-gmp-chapter-5part-1 - authorised representative 27 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-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;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 - Autonomous mobile machinery 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - benefit-risk determination 3 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrannex-ix/chapter-ii·chapter-i/article-2 - 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 5 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2 - CE marking of conformity 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - chains 6 clauses:
eu-ai-actchapter-vii/section-1/article-66;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 3 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrannex-ix/chapter-ii·chapter-i/article-2 - clinical evaluation 5 clauses:
eu-ivdrannex-ix/chapter-i/2.2;eu-mdrannex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-ix/chapter-ii·chapter-i/article-2 - clinical evidence 3 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrannex-ix/chapter-ii·chapter-i/article-2 - clinical investigation 2 clauses:
eu-mdrannex-i/chapter-iii·chapter-i/article-2 - clinical investigation plan 1 clause:
eu-mdrchapter-i/article-2 - clinical performance 5 clauses:
eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2;eu-mdrannex-i/chapter-iii·chapter-i/article-2·chapter-iii/article-32/1 - 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 2 clauses:
eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2 - Component / component 9 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-gmp-annex-1annex-1/11;eu-gmp-annex-1410;eu-gmp-annex-236;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;nist-ai-600-112·3 - conformity assessment 26 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-17/1·chapter-vi/article-57/7·chapter-vii/section-1/article-66;eu-cyber-resilience-actchapter-i/article-3;eu-cybersecurity-acttitle-iv/article-69/9;eu-digital-omnibus-aiarticle-1/6;eu-ivdrannex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-vii/3.4.2·annex-vii/4.3·chapter-i/section-1/article-2·chapter-iii/article-29/1·chapter-iv/article-38/8;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrannex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-ix/chapter-ii·annex-vii/3.4.2·annex-vii/4.3·annex-xi/part-a·chapter-i/article-2·chapter-iii/article-32/1·chapter-iv/article-42/8;nist-ai-600-112 - conformity assessment body 8 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-cybersecurity-acttitle-iv/article-69/9;eu-ivdrchapter-i/section-1/article-2·chapter-iv/article-38/8;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2·chapter-iv/article-42/8 - consumer 3 clauses:
eu-ai-actchapter-vii/section-1/article-66;eu-cyber-resilience-actchapter-i/article-3;nist-ai-600-112 - control material 1 clause:
eu-ivdrchapter-i/section-1/article-2 - corrective action 4 clauses:
eu-gmp-annex-1annex-1/11;eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2;ich-q124 - critical infrastructure 2 clauses:
eu-ai-actchapter-i/article-3;nist-ai-600-112 - CSIRT designated as coordinator 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - custom-made device 2 clauses:
eu-mdrannex-i/chapter-iii·chapter-i/article-2 - cyber threat 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - cybersecurity 5 clauses:
eu-ai-actchapter-vii/section-1/article-66;eu-cyber-resilience-actannex-viii/part-ii/3·annex-viii/part-iv/3.2·chapter-i/article-3;nist-ai-600-112 - cybersecurity risk 2 clauses:
eu-cyber-resilience-actchapter-i/article-3;nist-ai-600-112 - danger zone 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - deep fake 1 clause:
eu-ai-actchapter-i/article-3 - deployer 3 clauses:
eu-ai-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/4·article-1/6 - derivative 4 clauses:
eu-mdrannex-i/chapter-iii·annex-ix/chapter-ii·annex-xi/part-a·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 2 clauses:
eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2 - device for self-testing 1 clause:
eu-ivdrchapter-i/section-1/article-2 - 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 - distributor 5 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2 - 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 4 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2 - 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 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - entity 4 clauses:
eu-ai-actchapter-i/article-3;eu-gmp-annex-196.1;eu-gmp-annex-236;eu-gmp-chapter-5part-1 - essential health and safety requirements 4 clauses:
eu-machinery-regulationannex-iii/part-b/5·annex-ix/3.2·annex-x/2·chapter-i/article-3 - ethics committee 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - European standard 3 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - exploitable vulnerability 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - falsified device 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - field safety corrective action 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-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 2 clauses:
eu-ai-actchapter-i/article-3·chapter-v/section-2/article-54/1 - general-purpose AI system 1 clause:
eu-ai-actchapter-i/article-3 - generic device group 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - guard 3 clauses:
eu-gmp-chapter-8part-1;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - Guided load 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - hardware 6 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-gmp-annex-11-draft17;eu-ivdrannex-i/chapter-iii;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-i/chapter-iii;nist-ai-600-112 - Harm 1 clause:
nist-ai-600-112 - harmonised standard 6 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrchapter-i/article-2 - Hazard / hazard 6 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-chapter-2part-1;eu-gmp-chapter-3part-1;eu-ivdrannex-i/chapter-iii;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - health institution 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - high-impact capabilities 1 clause:
eu-ai-actchapter-i/article-3 - implantable device 2 clauses:
eu-mdrchapter-i/article-2·chapter-ii/article-18/1 - importer 8 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-gmp-annex-137;eu-gmp-annex-197.2;eu-gmp-chapter-5part-1;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2 - in vitro diagnostic medical device 2 clauses:
eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2 - incident 12 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-17/1·chapter-vii/section-1/article-66;eu-cyber-resilience-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;eu-mdrannex-i/chapter-iii·chapter-i/article-2;nist-ai-600-112 - indirect connection 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - informed consent 6 clauses:
eu-ai-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2·chapter-vi/article-59/1;eu-mdrchapter-i/article-2·chapter-vi/article-63/1;nist-ai-600-112 - input data 3 clauses:
eu-ai-actchapter-i/article-3;nist-ai-600-112·3 - instructions for use 12 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrannex-i/chapter-iii·annex-x/2·chapter-i/section-1/article-2·chapter-iii/article-29/1;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrannex-i/chapter-iii·annex-ix/chapter-ii·chapter-i/article-2·chapter-iii/article-32/1 - intended purpose 12 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-gmp-annex-1410;eu-gmp-chapter-3part-1;eu-ivdrannex-i/chapter-iii·annex-x/2·chapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrannex-i/chapter-iii·annex-ix/chapter-ii·chapter-i/article-2;nist-ai-600-112 - intended use 8 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-236;eu-gmp-chapter-1chapter-1;eu-gmp-chapter-6part-1;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-xi/part-a;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 - interventional clinical performance study 1 clause:
eu-ivdrchapter-i/section-1/article-2 - invasive device 1 clause:
eu-mdrchapter-i/article-2 - investigational device 1 clause:
eu-mdrchapter-i/article-2 - investigator 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - kit 2 clauses:
eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2 - label 11 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-chapter-5part-1;eu-gmp-chapter-6part-1;eu-ivdrannex-i/chapter-iii·annex-x/2·chapter-i/section-1/article-2·chapter-iii/article-29/1;eu-mdrannex-i/chapter-iii·chapter-i/article-2·chapter-iii/article-32/1;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 3 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2·chapter-ii/article-18/1 - lifetime 7 clauses:
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·chapter-ii/article-18/1 - lifting accessory 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - Lifting operation 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - likelihood ratio 1 clause:
eu-ivdrchapter-i/section-1/article-2 - logical connection 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - machinery 8 clauses:
eu-machinery-regulationannex-iii/part-b/5·annex-ix/3.1·annex-ix/3.2·annex-ix/5.2·annex-vii/3·annex-x/2·annex-x/5.2·chapter-i/article-3 - Machinery or related products for plant protection products application 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - Machinery or related products presenting risks due to their mobility 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - making available on the market 6 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrannex-i/chapter-iii·chapter-i/article-2 - manufacturer 53 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actannex-viii/part-i/4.2·annex-viii/part-ii/3·annex-viii/part-iii/3.2·annex-viii/part-iv/3.1·annex-viii/part-iv/3.2·annex-viii/part-iv/5.2·chapter-i/article-3·chapter-ii/article-18/1;eu-gmp-annex-1annex-1/11;eu-gmp-annex-1310·11.3·2·6.2·7;eu-gmp-annex-1410;eu-gmp-annex-197.2;eu-gmp-annex-236;eu-gmp-chapter-1chapter-1;eu-gmp-chapter-2part-1;eu-gmp-chapter-5part-1;eu-gmp-chapter-6part-1;eu-gmp-chapter-8part-1;eu-ivdrannex-i/chapter-iii·annex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-vii/4.3·annex-x/2·annex-xi/3.2·chapter-i/section-1/article-2·chapter-iii/article-29/1·chapter-iv/article-42/6;eu-machinery-regulationannex-iii/part-b/5·annex-ix/3.1·annex-ix/3.2·annex-ix/5.2·annex-vii/3·annex-x/2·annex-x/5.2·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-ix/chapter-ii·annex-vii/4.3·annex-x/2·annex-xi/part-a·chapter-i/article-2·chapter-ii/article-18/1·chapter-iii/article-32/1·chapter-iv/article-46/8;ich-q124 - market surveillance 12 clauses:
eu-ai-actchapter-i/article-3·chapter-vi/article-57/7·chapter-vii/section-1/article-66;eu-cyber-resilience-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/6;eu-ivdrannex-ix/chapter-i/2.1·chapter-i/section-1/article-2·chapter-iv/article-42/6;eu-machinery-regulationchapter-i/article-3;eu-mdrannex-ix/chapter-i/2.1·annex-ix/chapter-ii·chapter-i/article-2 - market surveillance authority 4 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/6;eu-machinery-regulationchapter-i/article-3 - medical device 5 clauses:
eu-gmp-annex-1410;eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2;eu-mdrannex-i/chapter-iii·chapter-i/article-2 - Metadata 1 clause:
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 7 clauses:
eu-ai-actchapter-i/article-3·chapter-vi/article-57/7;eu-digital-omnibus-aiarticle-1/6;eu-gmp-annex-137;eu-gmp-annex-1410;eu-gmp-annex-236;eu-ivdrchapter-iv/article-42/6 - near miss 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - negative predictive value 2 clauses:
eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2 - non-personal data 1 clause:
eu-ai-actchapter-i/article-3 - non-viable 3 clauses:
eu-gmp-annex-1annex-1/11;eu-mdrannex-ix/chapter-ii·chapter-i/article-2 - notified body 33 clauses:
eu-ai-actannex-vii/3.1·annex-vii/4.2·chapter-i/article-3;eu-cyber-resilience-actannex-viii/part-ii/3·annex-viii/part-iv/3.1·chapter-i/article-3;eu-digital-omnibus-aiarticle-1/6;eu-ivdrannex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-vii/2.4·annex-vii/3.4.2·annex-vii/4.3·annex-x/2·chapter-i/section-1/article-2·chapter-iii/article-29/1·chapter-iv/article-38/6·chapter-iv/article-42/6;eu-machinery-regulationannex-ix/3.1·annex-vii/3·annex-x/2·chapter-i/article-3;eu-mdrannex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-ix/chapter-ii·annex-vii/2.4·annex-vii/3.4.2·annex-vii/4.3·annex-x/2·annex-xi/part-a·chapter-i/article-2·chapter-iii/article-32/1·chapter-iv/article-42/6·chapter-iv/article-46/8 - notifying authority 2 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3 - online search engine 1 clause:
eu-digital-omnibus-aiarticle-1/6 - open-source software steward 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - operator 12 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-136.2;eu-gmp-annex-236;eu-gmp-chapter-2part-1;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrchapter-i/article-2;nist-ai-600-112 - particle 2 clauses:
eu-gmp-annex-1annex-1/11;eu-mdrchapter-i/article-2 - partly completed machinery 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - performance 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 - performance evaluation 3 clauses:
eu-ivdrannex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·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 2 clauses:
eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2 - performance study plan 1 clause:
eu-ivdrchapter-i/section-1/article-2 - personal data 4 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;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 8 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-17/1;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 - positive predictive value 1 clause:
eu-ivdrchapter-i/section-1/article-2 - post-market monitoring system 3 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-17/1;eu-digital-omnibus-aiarticle-1/6 - post-market surveillance 5 clauses:
eu-ivdrannex-ix/chapter-i/2.1·chapter-i/section-1/article-2;eu-mdrannex-ix/chapter-i/2.1·annex-ix/chapter-ii·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 1 clause:
ich-q124 - product with digital elements 5 clauses:
eu-cyber-resilience-actannex-viii/part-i/4.2·annex-viii/part-ii/3·annex-viii/part-iii/3.2·annex-viii/part-iv/5.2·chapter-i/article-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 10 clauses:
eu-ai-actannex-vii/3.1·annex-vii/4.2·chapter-i/article-3·chapter-iii/section-3/article-25/4·chapter-iii/section-5/article-47/1·chapter-vi/article-57/7;eu-digital-omnibus-aiarticle-1/4·article-1/6;eu-gmp-annex-11-draft17;nist-ai-600-112 - publicly accessible space 1 clause:
eu-ai-actchapter-i/article-3 - putting into service 7 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-17/1;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 - Quality 14 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-137;eu-gmp-annex-1410;eu-gmp-annex-162.2;eu-gmp-annex-236;eu-gmp-chapter-1chapter-1;eu-gmp-chapter-2part-1;eu-gmp-chapter-3part-1;eu-gmp-chapter-5part-1;eu-gmp-chapter-6part-1;eu-gmp-chapter-8part-1;eu-mdrannex-xi/part-a;ich-q124 - Quality Risk Management 8 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-162.2;eu-gmp-chapter-1chapter-1;eu-gmp-chapter-3part-1;eu-gmp-chapter-5part-1;eu-gmp-chapter-8part-1;ich-q124 - Quality System 5 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-chapter-1chapter-1;eu-gmp-chapter-2part-1;ich-q124 - 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 3 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-machinery-regulationannex-iii/part-b/5 - reasonably foreseeable use 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - recall 9 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/6;eu-gmp-annex-236;eu-gmp-chapter-1chapter-1;eu-gmp-chapter-8part-1;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2 - 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 - representative 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 - reprocessing 5 clauses:
eu-gmp-annex-1410;eu-gmp-chapter-5part-1;eu-gmp-chapter-6part-1;eu-mdrannex-i/chapter-iii·chapter-i/article-2 - Requirements 5 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-1410;eu-machinery-regulationannex-iii/part-b/5;ich-q124 - Risk / risk 33 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-17/1·chapter-iii/section-3/article-22/1·chapter-iii/section-3/article-25/4·chapter-iii/section-5/article-47/1;eu-cyber-resilience-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/4·article-1/6;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-1410;eu-gmp-annex-162.2;eu-gmp-annex-236;eu-gmp-chapter-1chapter-1;eu-gmp-chapter-2part-1;eu-gmp-chapter-3part-1;eu-gmp-chapter-5part-1;eu-gmp-chapter-6part-1;eu-gmp-chapter-8part-1;eu-ivdrannex-i/chapter-iii·annex-ix/chapter-i/2.2·chapter-i/section-1/article-2·chapter-iv/article-42/6;eu-machinery-regulationannex-iii/part-b/5·annex-x/2·chapter-i/article-3;eu-mdrannex-i/chapter-iii·annex-ix/chapter-i/2.2·annex-ix/chapter-ii·chapter-i/article-2;ich-q124;nist-ai-600-112·3 - Risk Management 10 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-162.2;eu-gmp-chapter-1chapter-1;eu-gmp-chapter-3part-1;eu-gmp-chapter-5part-1;eu-gmp-chapter-8part-1;ich-q124;nist-ai-600-112·3 - 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 - sensitive operational data 1 clause:
eu-ai-actchapter-i/article-3 - serious adverse event 4 clauses:
eu-gmp-annex-1410;eu-gmp-annex-236;eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - serious incident 7 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-17/1·chapter-vii/section-1/article-66;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 cybersecurity risk 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - single-use device 3 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrannex-i/chapter-iii·chapter-i/article-2 - SME 1 clause:
eu-gmp-annex-11-draft17 - software 10 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-gmp-annex-11-draft17;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;nist-ai-600-112·3 - software bill of materials 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - source code 2 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-machinery-regulationchapter-i/article-3 - 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 6 clauses:
eu-gmp-annex-1310·11.3·7;eu-gmp-chapter-8part-1;eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - Stakeholder 1 clause:
nist-ai-600-112 - standard 11 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-1410;eu-gmp-chapter-6part-1;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrchapter-i/article-2;nist-ai-600-112 - Static test 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - subject 23 clauses:
eu-ai-actchapter-i/article-3·chapter-vii/section-1/article-66;eu-cyber-resilience-actchapter-i/article-3;eu-cybersecurity-acttitle-iv/article-69/9;eu-digital-omnibus-aiarticle-1/6;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-136.2;eu-gmp-annex-1410;eu-gmp-annex-236;eu-gmp-chapter-2part-1;eu-gmp-chapter-6part-1;eu-ivdrannex-vii/3.4.2·chapter-i/section-1/article-2·chapter-vi/article-59/1;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-vii/3.4.2·annex-xi/part-a·chapter-i/article-2·chapter-vi/article-63/1;ich-q124;nist-ai-600-112·3 - substantial modification 3 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-machinery-regulationchapter-i/article-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 - support period 4 clauses:
eu-cyber-resilience-actannex-viii/part-i/4.2·annex-viii/part-iii/3.2·annex-viii/part-iv/5.2·chapter-i/article-3 - System / system 45 clauses:
eu-ai-actannex-vii/3.1·chapter-i/article-3·chapter-iii/section-3/article-17/1·chapter-iii/section-3/article-25/4·chapter-iii/section-5/article-47/1·chapter-vi/article-57/7;eu-cyber-resilience-actannex-viii/part-iv/3.1·annex-viii/part-iv/3.2·chapter-i/article-3;eu-digital-omnibus-aiarticle-1/4·article-1/6;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-132·7;eu-gmp-annex-1410;eu-gmp-annex-161.5.5·2.2;eu-gmp-annex-236;eu-gmp-chapter-1chapter-1;eu-gmp-chapter-2part-1;eu-gmp-chapter-3part-1;eu-gmp-chapter-5part-1;eu-gmp-chapter-6part-1;eu-gmp-chapter-8part-1;eu-ivdrannex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-vii/4.3·annex-xi/3.2·chapter-i/section-1/article-2·chapter-iv/article-42/6;eu-machinery-regulationannex-iii/part-b/5·annex-ix/3.1·annex-ix/3.2·annex-x/2·chapter-i/article-3;eu-mdrannex-ix/chapter-i/2.1·annex-ix/chapter-i/2.2·annex-ix/chapter-ii·annex-vii/4.3·annex-xi/part-a·chapter-i/article-2;ich-q124;nist-ai-600-112·3 - systemic risk 1 clause:
eu-ai-actchapter-i/article-3 - technical specifications 7 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-17/1·chapter-vii/section-1/article-66;eu-cyber-resilience-actannex-viii/part-ii/3·annex-viii/part-iv/3.2;eu-machinery-regulationannex-ix/3.2·chapter-i/article-3 - Test coefficient 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - testing data 2 clauses:
eu-ai-actchapter-i/article-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 3 clauses:
eu-ai-actchapter-i/article-3;nist-ai-600-112·3 - Trend 1 clause:
eu-gmp-chapter-6part-1 - UDI 5 clauses:
eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2;eu-mdrannex-i/chapter-iii·chapter-i/article-2·chapter-ii/article-18/1 - Union harmonisation legislation 8 clauses:
eu-ai-actchapter-i/article-3·chapter-vii/section-1/article-66;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 - user 14 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2·chapter-iii/article-29/1;eu-machinery-regulationannex-iii/part-b/5·annex-vii/3·chapter-i/article-3;eu-mdrannex-i/chapter-iii·annex-ix/chapter-ii·chapter-i/article-2·chapter-iii/article-32/1;nist-ai-600-112·3 - validation data 2 clauses:
eu-ai-actchapter-i/article-3;ich-q124 - validation data set 1 clause:
eu-ai-actchapter-i/article-3 - vulnerability 5 clauses:
eu-cyber-resilience-actannex-viii/part-ii/3·annex-viii/part-iv/3.2·chapter-i/article-3;eu-gmp-annex-11-draft17;nist-ai-600-112 - 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 7 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-gmp-annex-1410;eu-ivdrchapter-i/section-1/article-2·chapter-iv/article-42/6;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2 - withdrawal of an AI system 1 clause:
eu-ai-actchapter-i/article-3 - Working coefficient 1 clause:
eu-machinery-regulationannex-iii/part-b/5
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 | 2 | 2 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
58dbc3006d27 | 0 | 14 | 1 | |
9d16077b1d3b (current) | 0 | 14 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
9206a43954eb (current) | 0 | 9 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
1fe6027daa2c (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
92eb86f25281 (current) | 0 | 2 | 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 | 6 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
797a882ba0ea | 0 | 0 | 1 | |
53742d793b68 (current) | 0 | 0 | 1 | |
ac0054416554 | 0 | 0 | 1 | |
749c40132375 | 0 | 0 | 1 | |
f110d5d47c11 | 0 | 0 | 1 | |
bf56cba791d8 | 0 | 0 | 1 | |
3db9896305a6 | 0 | 0 | 1 |
| 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 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
48f21f2e4f1b unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
c4635c9c95ba (current) | 0 | 9 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
6eabc41e8879 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
ea32c21545ee (current) | 0 | 7 | 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 | 4 | 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 | 6 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
053f731102ad unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
c1a1d8a7fee4 (current) | 0 | 1 | 0 |
| 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 | 1 | |
07dc6a9975d1 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
f8b98469078e (current) | 0 | 0 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
2cb8ccdb053c unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
743cfcdd11a7 (current) | 0 | 2 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
e6dfb22ae579 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
fd6b0dfbb7fd (current) | 0 | 1 | 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 | 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 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
6d54bcfeb8e7 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
313242556edd (current) | 0 | 1 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
dccc2d038791 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
c0432468bd32 (current) | 0 | 3 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
ef49f58a80fe unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
b9143ae11461 (current) | 1 | 7 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
85a680107f4d unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
8f04120f403b (current) | 0 | 7 | 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 | 3 | 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 | 6 | 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 | 2 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
6af0146c0d0b unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
880033e05d95 (current) | 0 | 2 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
903e40aaebe6 (current) | 0 | 14 | 2 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
1fc20ae2ffd8 | 0 | 9 | 0 | |
82fb682a6c54 (current) | 0 | 9 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
14d00b77d5c8 | 0 | 20 | 1 | |
fab624c8e1dc (current) | 0 | 20 | 1 |
| 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 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
b8cd8587b556 (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
ad537c73610a (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
4843091843f0 (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
c30f5ac99d82 (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
b52b706d5cca (current) | 0 | 1 | 0 | |
d34d8c706d88 | 0 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
b52b706d5cca | 0 | 1 | 0 | |
27c5d1a28e3d unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
d34d8c706d88 (current) | 0 | 0 | 1 |
| 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 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
a5590943862c (current) | 0 | 1 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
4c3dca909c34 (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
d1889be52428 (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
2104fa729111 (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
c49d3a719515 (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
206fc2d61445 (current) | 0 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
a5ad5867c187 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
caa03fc84948 (current) | 0 | 1 | 1 |
| 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 | 37 | 0 | |
5997ebbb6661 | 0 | 37 | 0 | |
9d7b6d9aa4e1 | 0 | 37 | 0 | |
18e04a0c925a | 0 | 37 | 0 | |
1e7f13684129 | 0 | 37 | 0 | |
f24b92ecdf42 | 0 | 37 | 0 | |
b670ac9656b7 | 0 | 37 | 0 | |
bc527e48bcd8 | 0 | 37 | 0 | |
4edb9480421c | 0 | 37 | 0 | |
cd3e1c0c936b | 0 | 37 | 0 | |
75605421c92f (current) | 0 | 37 | 0 |
Feed
/atom/term/written.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 GMP Chapter 4 | 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 |
| EU GMP Annex 11 | true | open | true | true |
| FDA electronic systems (clinical) | true | open | true | true |
| 21 CFR Part 820 (QMSR) | true | open | true | true |
| 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 |
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: