operator
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: 1 of 2 definitions in this view is quoted and 1 is withheld with the reason. No reading here says that two of them agree or differ.
EU
- Defined in
- EU AI Act
chapter-i/article-3(8): a provider, product manufacturer, deployer, authorised representative, importer or distributor;EU Machinery Regulationannex-iii/part-a(d): text withheld (over the cap: its term and text are 19 words) - Rows printing it in a normative sentence
- 16
- 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
- 1
- Rows printing it in a title
- 0
- Rows printing it in body
- 2
US
- Defined in
- no current text of a row of this jurisdiction defines it
- Rows printing it in a normative sentence
- 3
- Rows printing it in a title
- 0
- Rows printing it in body
- 2
This form is printed by the
tracked documents, each as a document defines it. The index’s key is
operator (the definitions derivation’s fold:
case set aside, spaces collapsed; each form is matched exactly as printed).
4 observed texts define it.
Counts below are over each row’s current text, the
81 of 126 current
texts the derivation read; a title is read for every one of the 132 tracked rows.
Defined
2 definitions in 2 current texts, as the definitions derivation’s rules read them, quoted where the term and its text together sit under the quote cap.
- EU AI Act
EUtext first observedchapter-i/article-3(8)operator: a provider, product manufacturer, deployer, authorised representative, importer or distributor;
- EU Machinery Regulation
EUtext first observedannex-iii/part-a(d)operator: text withheld (over the cap: its term and text are 19 words)
In normative sentences
181 sentences in 20 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 observedfollows a withheld heading: 2 sentences (should) - EU AI Act
EU16 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-24/4: 1 sentence (shall) ·chapter-iii/section-4/article-31/4: 1 sentence (shall) ·chapter-ix/section-3/article-74/1: 1 sentence (shall) ·chapter-ix/section-3/article-79/2: 1 sentence (shall, may) ·chapter-ix/section-3/article-79/3: 1 sentence (shall) ·chapter-ix/section-3/article-79/4: 1 sentence (shall) ·chapter-ix/section-3/article-79/5: 1 sentence (shall) ·chapter-ix/section-3/article-79/6: 1 sentence (shall) ·chapter-ix/section-3/article-79/8: 1 sentence (shall) ·chapter-ix/section-3/article-81/1: 1 sentence (shall) ·chapter-ix/section-3/article-82/1: 1 sentence (shall, may) ·chapter-ix/section-3/article-82/2: 1 sentence (shall) ·chapter-xii/article-99/7: 1 sentence (shall) - EU Cyber Resilience Act
EU23 sentences; text first observedno clause anchor before this sentence: 7 sentences (should) ·chapter-i/article-3: 1 sentence (may) ·chapter-ii/article-23/1: 1 sentence (shall) ·chapter-v/article-53: 1 sentence (shall) ·chapter-v/article-54/1: 1 sentence (shall, may) ·chapter-v/article-54/3: 1 sentence (shall) ·chapter-v/article-54/4: 1 sentence (shall) ·chapter-v/article-54/5: 1 sentence (shall) ·chapter-v/article-54/6: 1 sentence (shall) ·chapter-v/article-55/1: 1 sentence (shall) ·chapter-v/article-56/4: 1 sentence (shall) ·chapter-v/article-56/6: 1 sentence (shall) ·chapter-v/article-57/1: 1 sentence (shall) ·chapter-v/article-57/4: 1 sentence (shall) ·chapter-v/article-57/8: 1 sentence (shall) ·chapter-v/article-57/10: 1 sentence (shall) ·chapter-vii/article-64/5: 1 sentence (shall) - Regulation (EU) 2026/1744
EU17 sentences; text first observedarticle-1/6: 6 sentences (shall, may) ·article-1/8: 10 sentences (may, shall, should) ·article-1/9: 1 sentence (shall) - EU GMP Annex 1
EU12 sentences; text first observedannex-1/11: 12 sentences (should, may) - EU GMP Annex 11
EU1 sentence; text first observed6: 1 sentence (may) - EU GMP Annex 12
EU4 sentences; text first observed1: 1 sentence (may, must) ·12: 1 sentence (must) ·43: 1 sentence (should) ·44: 1 sentence (should) - EU GMP Annex 13
EU1 sentence; text first observed6.2: 1 sentence (should) - EU GMP Annex 15
EU1 sentence; text first observed3.12: 1 sentence (should) - EU GMP Annex 2
EU2 sentences; text first observed10: 1 sentence (should) ·36: 1 sentence (should) - EU GMP Annex 22
EU3 sentences; text first observed10: 2 sentences (should) ·10.5: 1 sentence (should) - EU GMP Chapter 2
EU1 sentence; text first observedpart-1: 1 sentence (should) - EU GMP Chapter 4
EU2 sentences; text first observedno numbering read: 2 sentences (should) - EU IVDR
EU17 sentences; text first observedchapter-iii/article-22/2: 1 sentence (shall) ·chapter-iii/article-28/4: 1 sentence (shall) ·chapter-iii/article-28/5: 2 sentences (shall, may) ·chapter-iii/article-28/6: 1 sentence (shall) ·chapter-vii/section-3/article-88/7: 2 sentences (shall) ·chapter-vii/section-3/article-90/1: 1 sentence (shall) ·chapter-vii/section-3/article-90/4: 1 sentence (shall) ·chapter-vii/section-3/article-90/5: 1 sentence (shall) ·chapter-vii/section-3/article-92/1: 1 sentence (shall) ·chapter-vii/section-3/article-92/2: 1 sentence (shall) ·chapter-vii/section-3/article-94/1: 1 sentence (shall) ·chapter-vii/section-3/article-94/2: 2 sentences (shall) ·chapter-vii/section-3/article-94/3: 1 sentence (shall) ·annex-vii/1.2.1: 1 sentence (shall) - EU Machinery Regulation
EU57 sentences; text first observedno clause anchor before this sentence: 3 sentences (should) ·chapter-i/article-3: 1 sentence (may) ·chapter-ii/article-19/1: 1 sentence (shall) ·chapter-vi/article-43/1: 1 sentence (shall) ·chapter-vi/article-43/2: 1 sentence (shall) ·chapter-vi/article-43/3: 1 sentence (shall) ·chapter-vi/article-43/4: 1 sentence (shall) ·chapter-vi/article-43/5: 1 sentence (shall) ·chapter-vi/article-44/1: 2 sentences (shall) ·chapter-vi/article-45/1: 1 sentence (shall) ·chapter-vi/article-45/2: 1 sentence (shall) ·chapter-vi/article-45/4: 1 sentence (shall) ·chapter-vi/article-45/5: 1 sentence (shall) ·chapter-vi/article-46/1: 1 sentence (shall) ·chapter-vi/article-46/2: 1 sentence (shall) ·annex-iii/part-a: 1 sentence (may) ·annex-iii/part-b/5: 38 sentences (shall, should, may) - EU MDR
EU18 sentences; text first observedchapter-i/article-2: 1 sentence (shall, may) ·chapter-iii/article-25/2: 1 sentence (shall) ·chapter-iii/article-31/4: 1 sentence (shall) ·chapter-iii/article-31/5: 2 sentences (shall, may) ·chapter-iii/article-31/6: 1 sentence (shall) ·chapter-vii/section-3/article-93/7: 2 sentences (shall) ·chapter-vii/section-3/article-95/1: 1 sentence (shall) ·chapter-vii/section-3/article-95/4: 1 sentence (shall) ·chapter-vii/section-3/article-95/5: 1 sentence (shall) ·chapter-vii/section-3/article-97/1: 1 sentence (shall) ·chapter-vii/section-3/article-97/2: 1 sentence (shall) ·chapter-vii/section-3/article-99/1: 1 sentence (shall) ·chapter-vii/section-3/article-99/2: 2 sentences (shall) ·chapter-vii/section-3/article-99/3: 1 sentence (shall) ·annex-vii/1.2.1: 1 sentence (shall) - FDA device cybersecurity (2026)
US1 sentence; text first observed6: 1 sentence (should) - NIST AI RMF
International1 sentence; text first observed3.4: 1 sentence (should) - NISTIR 8183
US1 sentence; text first observed7: 1 sentence (may) - 21 CFR Part 11
US1 sentence; text first observedno numbering read: 1 sentence (should)
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
30 occurrences in 13 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.
- EU AI Act
EU4 occurrences; text first observed4 where no heading is read before it - EU Cyber Resilience Act
EU2 occurrences; text first observedchapter-v/article-54/8: 1 · 1 where no heading is read before it - EU Cybersecurity Act
EU2 occurrences; text first observedtitle-i/article-2: 2 - EU GMP Annex 1
EU1 occurrence; text first observedannex-1/11: 1 - EU GMP Annex 12
EU3 occurrences; text first observed16: 1 ·2: 1 ·24: 1 - EU GMP Chapter 4 (draft)
EU2 occurrences; text first observed2 where no numbering read in this text - EU IVDR
EU4 occurrences; text first observedannex-vi/part-a/1: 3 ·chapter-i/section-1/article-2: 1 - EU Machinery Regulation
EU3 occurrences; text first observedannex-iii/part-b/5: 1 · 2 where no heading is read before it - EU MDR
EU3 occurrences; text first observedannex-vi/part-a/1: 3 - FDA device cybersecurity (2026)
US2 occurrences; text first observed6: 2 - ICH Q13
International1 occurrence; text first observed1 where the heading before it is withheld - NIST AI 600-1
US1 occurrence; text first observed12: 1 - NIST AI RMF
International2 occurrences; text first observed5.2: 1 ·6: 1
Co-occurrence
246 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. 27 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 2 clauses:
eu-cybersecurity-acttitle-i/article-2;eu-machinery-regulationchapter-i/article-3 - Act 1 clause:
fda-device-cybersecurity-20266 - active device 1 clause:
eu-mdrchapter-i/article-2 - actively exploited vulnerability 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - adverse event 3 clauses:
eu-gmp-annex-236;eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - Agency 2 clauses:
fda-device-cybersecurity-20266;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 4 clauses:
eu-ai-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/6·article-1/8·article-1/9 - AI regulatory sandbox 2 clauses:
eu-ai-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/6 - AI system 15 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-24/4·chapter-iii/section-4/article-31/4·chapter-ix/section-3/article-79/2·chapter-ix/section-3/article-79/5·chapter-ix/section-3/article-79/6·chapter-ix/section-3/article-82/1·chapter-xii/article-99/7;eu-digital-omnibus-aiarticle-1/6·article-1/8;eu-gmp-annex-2210.5;nist-ai-600-112;nist-ai-rmf3.4·5.2·6 - allow-list 1 clause:
fda-device-cybersecurity-20266 - analytical performance 1 clause:
eu-ivdrchapter-i/section-1/article-2 - Application 5 clauses:
eu-digital-omnibus-aiarticle-1/9;eu-machinery-regulationannex-iii/part-b/5;fda-device-cybersecurity-20266;nist-ai-rmf6;nistir-81837 - assurance level 2 clauses:
eu-cybersecurity-acttitle-i/article-2;eu-gmp-annex-1annex-1/11 - authorised representative 10 clauses:
eu-ai-actchapter-i/article-3;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-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 - Autonomous mobile machinery 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - benefit-risk determination 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-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 2 clauses:
eu-ai-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/9 - biometric verification 1 clause:
eu-ai-actchapter-i/article-3 - calibrator 1 clause:
eu-ivdrchapter-i/section-1/article-2 - Carrier 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - CE marking 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·chapter-vi/article-46/1;eu-mdrchapter-i/article-2 - CE marking of conformity 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - chains 4 clauses:
eu-gmp-annex-236;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;nist-ai-600-112 - clinical benefit 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - clinical data 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - clinical evaluation 1 clause:
eu-mdrchapter-i/article-2 - clinical evidence 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - clinical investigation 1 clause:
eu-mdrchapter-i/article-2 - clinical investigation plan 1 clause:
eu-mdrchapter-i/article-2 - clinical performance 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - 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 1 clause:
eu-ivdrchapter-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-236;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;fda-device-cybersecurity-20266;nist-ai-600-112;nistir-81837 - conformity assessment 13 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-4/article-31/4;eu-cyber-resilience-actchapter-i/article-3;eu-cybersecurity-acttitle-i/article-2;eu-digital-omnibus-aiarticle-1/6·article-1/9;eu-ivdrannex-vii/1.2.1·chapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrannex-vii/1.2.1·chapter-i/article-2;nist-ai-600-112 - conformity assessment body 7 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-4/article-31/4;eu-cyber-resilience-actchapter-i/article-3;eu-cybersecurity-acttitle-i/article-2;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2 - conformity self-assessment 1 clause:
eu-cybersecurity-acttitle-i/article-2 - consumer 3 clauses:
eu-cyber-resilience-actchapter-i/article-3;nist-ai-600-112;nistir-81837 - control material 1 clause:
eu-ivdrchapter-i/section-1/article-2 - corrective action 19 clauses:
eu-ai-actchapter-ix/section-3/article-79/4·chapter-ix/section-3/article-79/5·chapter-ix/section-3/article-82/2;eu-cyber-resilience-actchapter-v/article-54/4·chapter-v/article-54/5;eu-gmp-annex-1annex-1/11;eu-ivdrchapter-i/section-1/article-2·chapter-vii/section-3/article-90/1·chapter-vii/section-3/article-90/4·chapter-vii/section-3/article-94/3;eu-machinery-regulationchapter-vi/article-43/1·chapter-vi/article-43/3·chapter-vi/article-43/4·chapter-vi/article-45/2;eu-mdrchapter-i/article-2·chapter-vii/section-3/article-95/1·chapter-vii/section-3/article-95/4·chapter-vii/section-3/article-99/3;fda-device-cybersecurity-20266 - critical infrastructure 3 clauses:
eu-ai-actchapter-i/article-3;nist-ai-600-112;nistir-81837 - CSIRT designated as coordinator 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - custom-made device 1 clause:
eu-mdrchapter-i/article-2 - cyber threat 3 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-cybersecurity-acttitle-i/article-2;fda-device-cybersecurity-20266 - cybersecurity 10 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-v/article-53·chapter-v/article-54/1·chapter-v/article-54/6·chapter-v/article-57/1;eu-cybersecurity-acttitle-i/article-2;fda-device-cybersecurity-20266;nist-ai-600-112;nist-ai-rmf6;nistir-81837 - cybersecurity risk 7 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-v/article-54/1·chapter-v/article-57/1;fda-device-cybersecurity-20266;nist-ai-600-112;nist-ai-rmf6;nistir-81837 - danger zone 2 clauses:
eu-machinery-regulationannex-iii/part-a·annex-iii/part-b/5 - deep fake 1 clause:
eu-ai-actchapter-i/article-3 - deployer 3 clauses:
eu-ai-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/6·article-1/9 - derivative 1 clause:
eu-mdrchapter-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 1 clause:
eu-ivdrchapter-i/section-1/article-2 - device for self-testing 1 clause:
eu-ivdrchapter-i/section-1/article-2 - device software function 1 clause:
fda-device-cybersecurity-20266 - diagnostic sensitivity 1 clause:
eu-ivdrchapter-i/section-1/article-2 - diagnostic specificity 1 clause:
eu-ivdrchapter-i/section-1/article-2 - digital service 1 clause:
eu-cybersecurity-acttitle-i/article-2 - digital service provider 1 clause:
eu-cybersecurity-acttitle-i/article-2 - distributor 6 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-24/4;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 64 clauses:
eu-ai-actchapter-ix/section-3/article-74/1;eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-23/1·chapter-v/article-53·chapter-v/article-54/1·chapter-v/article-54/3·chapter-v/article-54/4·chapter-v/article-54/5·chapter-v/article-54/6·chapter-v/article-54/8·chapter-v/article-55/1·chapter-v/article-56/4·chapter-v/article-56/6·chapter-v/article-57/1·chapter-v/article-57/10·chapter-v/article-57/4·chapter-v/article-57/8·chapter-vii/article-64/5;eu-ivdrannex-vi/part-a/1·annex-vii/1.2.1·chapter-i/section-1/article-2·chapter-iii/article-22/2·chapter-iii/article-28/4·chapter-iii/article-28/5·chapter-iii/article-28/6·chapter-vii/section-3/article-88/7·chapter-vii/section-3/article-90/1·chapter-vii/section-3/article-90/4·chapter-vii/section-3/article-90/5·chapter-vii/section-3/article-92/1·chapter-vii/section-3/article-92/2·chapter-vii/section-3/article-94/1·chapter-vii/section-3/article-94/2·chapter-vii/section-3/article-94/3;eu-machinery-regulationchapter-i/article-3·chapter-ii/article-19/1·chapter-vi/article-43/1·chapter-vi/article-43/2·chapter-vi/article-43/3·chapter-vi/article-43/4·chapter-vi/article-43/5·chapter-vi/article-44/1·chapter-vi/article-45/1·chapter-vi/article-45/2·chapter-vi/article-45/4·chapter-vi/article-45/5·chapter-vi/article-46/1·chapter-vi/article-46/2;eu-mdrannex-vi/part-a/1·annex-vii/1.2.1·chapter-i/article-2·chapter-iii/article-25/2·chapter-iii/article-31/4·chapter-iii/article-31/5·chapter-iii/article-31/6·chapter-vii/section-3/article-93/7·chapter-vii/section-3/article-95/1·chapter-vii/section-3/article-95/4·chapter-vii/section-3/article-95/5·chapter-vii/section-3/article-97/1·chapter-vii/section-3/article-97/2·chapter-vii/section-3/article-99/1·chapter-vii/section-3/article-99/2·chapter-vii/section-3/article-99/3 - electronic information system 2 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-v/article-57/1 - emotion recognition system 1 clause:
eu-ai-actchapter-i/article-3 - end-point 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - end-to-end 1 clause:
fda-device-cybersecurity-20266 - entity 3 clauses:
eu-ai-actchapter-i/article-3;eu-gmp-annex-236;fda-device-cybersecurity-20266 - essential health and safety requirements 4 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3·chapter-vi/article-43/5·chapter-vi/article-45/1 - ethics committee 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - European cybersecurity certificate 1 clause:
eu-cybersecurity-acttitle-i/article-2 - European cybersecurity certification scheme 1 clause:
eu-cybersecurity-acttitle-i/article-2 - European standard 3 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - exploitable vulnerability 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - exposed person 1 clause:
eu-machinery-regulationannex-iii/part-a - falsified device 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - Federal Food, Drug, and Cosmetic Act 1 clause:
fda-device-cybersecurity-20266 - 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 1 clause:
eu-ai-actchapter-i/article-3 - 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-machinery-regulationannex-iii/part-a·annex-iii/part-b/5·chapter-i/article-3 - Guided load 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - hardware 5 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-machinery-regulationannex-iii/part-b/5;fda-device-cybersecurity-20266;nist-ai-600-112;nistir-81837 - Harm 2 clauses:
fda-device-cybersecurity-20266;nist-ai-600-112 - harmonised standard 6 clauses:
eu-ai-actchapter-i/article-3;eu-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 5 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-chapter-2part-1;eu-machinery-regulationannex-iii/part-a·annex-iii/part-b/5·chapter-i/article-3 - health institution 4 clauses:
eu-ivdrchapter-i/section-1/article-2·chapter-iii/article-22/2;eu-mdrchapter-i/article-2·chapter-iii/article-25/2 - high-impact capabilities 1 clause:
eu-ai-actchapter-i/article-3 - ICT process 1 clause:
eu-cybersecurity-acttitle-i/article-2 - ICT product 1 clause:
eu-cybersecurity-acttitle-i/article-2 - ICT service 1 clause:
eu-cybersecurity-acttitle-i/article-2 - identity management 1 clause:
fda-device-cybersecurity-20266 - implantable device 1 clause:
eu-mdrchapter-i/article-2 - importer 8 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-24/4;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrannex-vi/part-a/1·chapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrannex-vi/part-a/1·chapter-i/article-2 - in vitro diagnostic medical device 1 clause:
eu-ivdrchapter-i/section-1/article-2 - incident 11 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-cybersecurity-acttitle-i/article-2;eu-gmp-annex-1annex-1/11;eu-gmp-annex-236;eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2;fda-device-cybersecurity-20266;nist-ai-600-112;nist-ai-rmf5.2;nistir-81837 - incident handling 2 clauses:
eu-cybersecurity-acttitle-i/article-2;nistir-81837 - indirect connection 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - informed consent 5 clauses:
eu-ai-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2;fda-device-cybersecurity-20266;nist-ai-600-112 - input data 3 clauses:
eu-ai-actchapter-i/article-3;eu-gmp-annex-2210.5;nist-ai-600-112 - instructions for use 7 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-a·annex-iii/part-b/5·chapter-i/article-3;eu-mdrchapter-i/article-2 - intended purpose 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-mdrchapter-i/article-2;nist-ai-600-112 - intended use 9 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-236;eu-gmp-annex-2210;eu-machinery-regulationannex-iii/part-a·annex-iii/part-b/5;fda-device-cybersecurity-20266;nist-ai-600-112;nist-ai-rmf3.4·5.2 - interchangeable equipment 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - international standard 2 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-gmp-annex-1annex-1/11 - 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 1 clause:
eu-ivdrchapter-i/section-1/article-2 - label 4 clauses:
eu-gmp-annex-1annex-1/11;eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2;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 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - lifetime 4 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrchapter-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 6 clauses:
eu-digital-omnibus-aiarticle-1/9;eu-machinery-regulationannex-iii/part-a·annex-iii/part-b/5·chapter-i/article-3·chapter-vi/article-46/1·chapter-vi/article-46/2 - Machinery or related products for plant protection products application 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - Machinery or related products presenting risks due to their mobility 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - making available on the market 5 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2 - manufacturer 23 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3·chapter-v/article-54/6·chapter-v/article-57/1;eu-cybersecurity-acttitle-i/article-2;eu-gmp-annex-1annex-1/11;eu-gmp-annex-121·2;eu-gmp-annex-136.2;eu-gmp-annex-236;eu-gmp-chapter-2part-1;eu-ivdrannex-vi/part-a/1·annex-vii/1.2.1·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·annex-vii/1.2.1·chapter-i/article-2·chapter-vii/section-3/article-95/1;fda-device-cybersecurity-20266;nistir-81837 - market surveillance 29 clauses:
eu-ai-actchapter-i/article-3·chapter-ix/section-3/article-79/2·chapter-ix/section-3/article-79/3·chapter-ix/section-3/article-79/5·chapter-ix/section-3/article-79/6·chapter-ix/section-3/article-79/8·chapter-ix/section-3/article-81/1·chapter-ix/section-3/article-82/1·chapter-ix/section-3/article-82/2·chapter-xii/article-99/7;eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-23/1·chapter-v/article-53·chapter-v/article-54/1·chapter-v/article-54/3·chapter-v/article-54/5·chapter-v/article-54/6·chapter-v/article-57/1·chapter-vii/article-64/5;eu-digital-omnibus-aiarticle-1/6·article-1/9;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3·chapter-ii/article-19/1·chapter-vi/article-43/1·chapter-vi/article-43/2·chapter-vi/article-43/4·chapter-vi/article-43/5;eu-mdrchapter-i/article-2 - market surveillance authority 17 clauses:
eu-ai-actchapter-i/article-3·chapter-ix/section-3/article-79/2·chapter-ix/section-3/article-79/3·chapter-ix/section-3/article-79/5·chapter-ix/section-3/article-79/8·chapter-ix/section-3/article-81/1·chapter-ix/section-3/article-82/1·chapter-ix/section-3/article-82/2;eu-cyber-resilience-actchapter-i/article-3·chapter-v/article-54/1·chapter-v/article-54/3·chapter-v/article-54/5·chapter-v/article-54/6·chapter-v/article-57/1;eu-digital-omnibus-aiarticle-1/6·article-1/9;eu-machinery-regulationchapter-i/article-3 - medical device 3 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2;fda-device-cybersecurity-20266 - Metadata 1 clause:
nist-ai-600-112 - nanomaterial 1 clause:
eu-mdrchapter-i/article-2 - national accreditation body 2 clauses:
eu-cybersecurity-acttitle-i/article-2;eu-machinery-regulationchapter-i/article-3 - national competent authority 4 clauses:
eu-ai-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/6·article-1/9;eu-gmp-annex-236 - national cybersecurity certification scheme 1 clause:
eu-cybersecurity-acttitle-i/article-2 - national strategy on the security of network and information systems 1 clause:
eu-cybersecurity-acttitle-i/article-2 - near miss 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - negative predictive value 1 clause:
eu-ivdrchapter-i/section-1/article-2 - network and information system 1 clause:
eu-cybersecurity-acttitle-i/article-2 - non-personal data 1 clause:
eu-ai-actchapter-i/article-3 - non-viable 2 clauses:
eu-gmp-annex-1annex-1/11;eu-mdrchapter-i/article-2 - notified body 14 clauses:
eu-ai-actchapter-i/article-3·chapter-ix/section-3/article-79/2;eu-cyber-resilience-actchapter-i/article-3·chapter-v/article-54/1;eu-digital-omnibus-aiarticle-1/6;eu-ivdrannex-vii/1.2.1·chapter-i/section-1/article-2·chapter-vii/section-3/article-90/4;eu-machinery-regulationchapter-i/article-3·chapter-vi/article-43/1·chapter-vi/article-46/1;eu-mdrannex-vii/1.2.1·chapter-i/article-2·chapter-vii/section-3/article-95/4 - 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 of essential services 1 clause:
eu-cybersecurity-acttitle-i/article-2 - particle 2 clauses:
eu-gmp-annex-1annex-1/11;eu-mdrchapter-i/article-2 - partly completed machinery 3 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3·chapter-vi/article-46/2 - performance 15 clauses:
eu-ai-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/6;eu-gmp-annex-1annex-1/11;eu-gmp-annex-236;eu-gmp-annex-2210·10.5;eu-gmp-chapter-2part-1;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5;eu-mdrchapter-i/article-2;fda-device-cybersecurity-20266;nist-ai-600-112;nist-ai-rmf5.2·6;nistir-81837 - performance evaluation 1 clause:
eu-ivdrchapter-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 1 clause:
eu-ivdrchapter-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 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 - 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 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - post-remote biometric identification system 1 clause:
eu-ai-actchapter-i/article-3 - predictive value 1 clause:
eu-ivdrchapter-i/section-1/article-2 - procedure pack 1 clause:
eu-mdrchapter-i/article-2 - product with digital elements 6 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-23/1·chapter-v/article-54/1·chapter-v/article-54/5·chapter-v/article-54/6·chapter-v/article-57/1 - 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 2 clauses:
eu-machinery-regulationannex-iii/part-a·annex-iii/part-b/5 - provider 11 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-24/4·chapter-iii/section-4/article-31/4·chapter-ix/section-3/article-82/2;eu-cybersecurity-acttitle-i/article-2;eu-digital-omnibus-aiarticle-1/6·article-1/9;eu-gmp-annex-2210;fda-device-cybersecurity-20266;nist-ai-600-112;nistir-81837 - publicly accessible space 1 clause:
eu-ai-actchapter-i/article-3 - putting into service 6 clauses:
eu-ai-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 - Quality 6 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-236;eu-gmp-annex-2210;eu-gmp-chapter-2part-1;fda-device-cybersecurity-20266;nistir-81837 - Quality Risk Management 2 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-2210 - Quality System 3 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-chapter-2part-1;fda-device-cybersecurity-20266 - real-time remote biometric identification system 1 clause:
eu-ai-actchapter-i/article-3 - real-world testing plan 2 clauses:
eu-ai-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/6 - reasonably foreseeable misuse 5 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-machinery-regulationannex-iii/part-a·annex-iii/part-b/5;fda-device-cybersecurity-20266 - reasonably foreseeable use 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - recall 18 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-24/4·chapter-ix/section-3/article-79/2·chapter-ix/section-3/article-79/5;eu-cyber-resilience-actchapter-i/article-3·chapter-v/article-54/1·chapter-v/article-54/5;eu-digital-omnibus-aiarticle-1/6;eu-gmp-annex-236;eu-ivdrchapter-i/section-1/article-2·chapter-vii/section-3/article-90/1·chapter-vii/section-3/article-90/4;eu-machinery-regulationchapter-i/article-3·chapter-vi/article-45/1;eu-mdrchapter-i/article-2·chapter-vii/section-3/article-95/1·chapter-vii/section-3/article-95/4;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 - representative 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 - reprocessing 1 clause:
eu-mdrchapter-i/article-2 - Requirements 4 clauses:
eu-gmp-annex-1annex-1/11;eu-machinery-regulationannex-iii/part-b/5;fda-device-cybersecurity-20266;nistir-81837 - Risk / risk 39 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-24/4·chapter-iii/section-4/article-31/4·chapter-ix/section-3/article-79/2·chapter-ix/section-3/article-79/6·chapter-ix/section-3/article-82/1;eu-cyber-resilience-actchapter-i/article-3·chapter-v/article-54/1·chapter-v/article-54/6·chapter-v/article-57/1;eu-digital-omnibus-aiarticle-1/6·article-1/9;eu-gmp-annex-1annex-1/11;eu-gmp-annex-116;eu-gmp-annex-236;eu-gmp-annex-2210;eu-gmp-chapter-2part-1;eu-ivdrchapter-i/section-1/article-2·chapter-vii/section-3/article-90/1·chapter-vii/section-3/article-90/5·chapter-vii/section-3/article-92/1·chapter-vii/section-3/article-94/2;eu-machinery-regulationannex-iii/part-a·annex-iii/part-b/5·chapter-i/article-3·chapter-vi/article-43/1·chapter-vi/article-43/4·chapter-vi/article-43/5·chapter-vi/article-45/1;eu-mdrchapter-i/article-2·chapter-vii/section-3/article-95/1·chapter-vii/section-3/article-95/5·chapter-vii/section-3/article-97/1·chapter-vii/section-3/article-99/2;fda-device-cybersecurity-20266;nist-ai-600-112;nist-ai-rmf5.2·6;nistir-81837 - Risk Assessment 2 clauses:
fda-device-cybersecurity-20266;nistir-81837 - Risk Management 6 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-2210;fda-device-cybersecurity-20266;nist-ai-600-112;nist-ai-rmf6;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-cybersecurity-acttitle-i/article-2 - 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 3 clauses:
eu-ai-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - serious public health threat 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - significant cybersecurity risk 4 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-v/article-54/1·chapter-v/article-57/1;fda-device-cybersecurity-20266 - single-use device 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - SME 2 clauses:
eu-gmp-annex-2210;nist-ai-rmf6 - software 9 clauses:
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;fda-device-cybersecurity-20266;nist-ai-600-112;nist-ai-rmf6;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 3 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2;fda-device-cybersecurity-20266 - Stakeholder 1 clause:
nist-ai-600-112 - standard 12 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-cybersecurity-acttitle-i/article-2;eu-gmp-annex-1annex-1/11;eu-gmp-annex-153.12;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrchapter-i/article-2;fda-device-cybersecurity-20266;nist-ai-600-112;nist-ai-rmf6 - Static test 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - subject 24 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/6·article-1/8·article-1/9;eu-gmp-annex-1annex-1/11;eu-gmp-annex-136.2;eu-gmp-annex-236;eu-gmp-annex-2210;eu-gmp-chapter-2part-1;eu-ivdrchapter-i/section-1/article-2·chapter-vii/section-3/article-88/7·chapter-vii/section-3/article-90/1·chapter-vii/section-3/article-94/1;eu-machinery-regulationannex-iii/part-a·annex-iii/part-b/5;eu-mdrchapter-i/article-2·chapter-vii/section-3/article-93/7·chapter-vii/section-3/article-95/1·chapter-vii/section-3/article-99/1;fda-device-cybersecurity-20266;nist-ai-600-112;nist-ai-rmf3.4·6 - 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 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - System / system 37 clauses:
eu-ai-actchapter-i/article-3·chapter-iii/section-3/article-24/4·chapter-iii/section-4/article-31/4·chapter-ix/section-3/article-79/2·chapter-ix/section-3/article-79/5·chapter-ix/section-3/article-79/6·chapter-ix/section-3/article-82/1·chapter-xii/article-99/7;eu-cyber-resilience-actchapter-i/article-3·chapter-v/article-57/1;eu-cybersecurity-acttitle-i/article-2;eu-digital-omnibus-aiarticle-1/6·article-1/8;eu-gmp-annex-1annex-1/11;eu-gmp-annex-116;eu-gmp-annex-236;eu-gmp-annex-2210·10.5;eu-gmp-chapter-2part-1;eu-ivdrchapter-i/section-1/article-2·chapter-iii/article-28/4·chapter-vii/section-3/article-88/7·chapter-vii/section-3/article-90/4·chapter-vii/section-3/article-92/2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrchapter-i/article-2·chapter-iii/article-31/4·chapter-vii/section-3/article-93/7·chapter-vii/section-3/article-95/4·chapter-vii/section-3/article-97/2;fda-device-cybersecurity-20266;nist-ai-600-112;nist-ai-rmf3.4·5.2·6;nistir-81837 - systemic risk 1 clause:
eu-ai-actchapter-i/article-3 - technical specification 1 clause:
eu-cybersecurity-acttitle-i/article-2 - technical specifications 2 clauses:
eu-ai-actchapter-i/article-3;eu-machinery-regulationchapter-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 5 clauses:
eu-ai-actchapter-i/article-3;eu-gmp-annex-2210·10.5;nist-ai-600-112;nist-ai-rmf3.4 - UDI 3 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2;fda-device-cybersecurity-20266 - Union harmonisation legislation 9 clauses:
eu-ai-actchapter-i/article-3·chapter-ix/section-3/article-79/2;eu-cyber-resilience-actchapter-i/article-3;eu-digital-omnibus-aiarticle-1/6·article-1/9;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 12 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-2210;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrchapter-i/article-2;fda-device-cybersecurity-20266;nist-ai-600-112;nist-ai-rmf3.4·5.2·6;nistir-81837 - validation data 1 clause:
eu-ai-actchapter-i/article-3 - validation data set 1 clause:
eu-ai-actchapter-i/article-3 - vulnerability 6 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-v/article-53·chapter-v/article-54/1;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 6 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-i/article-3·chapter-v/article-57/1;eu-ivdrchapter-i/section-1/article-2;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 - written 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
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 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
58dbc3006d27 | 1 | 16 | 4 | |
9d16077b1d3b (current) | 1 | 16 | 4 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
9206a43954eb (current) | 0 | 23 | 2 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
1fe6027daa2c (current) | 0 | 0 | 2 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
92eb86f25281 (current) | 0 | 17 | 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 | 12 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
797a882ba0ea | 0 | 0 | 0 | |
53742d793b68 (current) | 0 | 1 | 0 | |
ac0054416554 | 0 | 0 | 0 | |
749c40132375 | 0 | 0 | 0 | |
f110d5d47c11 | 0 | 0 | 0 | |
bf56cba791d8 | 0 | 0 | 0 | |
3db9896305a6 | 0 | 0 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
791686510e26 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
b3718fa9a670 (current) | 0 | 4 | 3 |
| 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 | 1 | 0 |
| 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 |
|---|---|---|---|---|
053f731102ad unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
c1a1d8a7fee4 (current) | 0 | 2 | 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 | 3 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
6d54bcfeb8e7 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
313242556edd (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
ef49f58a80fe unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
b9143ae11461 (current) | 0 | 2 | 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 | 0 | 2 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
903e40aaebe6 (current) | 0 | 17 | 4 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
1fc20ae2ffd8 | 1 | 57 | 3 | |
82fb682a6c54 (current) | 1 | 57 | 3 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
14d00b77d5c8 | 0 | 18 | 3 | |
fab624c8e1dc (current) | 0 | 18 | 3 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
b52b706d5cca (current) | 0 | 0 | 0 | |
d34d8c706d88 | 0 | 1 | 2 |
| 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 | 2 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
06273204f50b (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 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
8afebcc0941a | 0 | 0 | 0 | |
c240f2675bd3 | 0 | 0 | 0 | |
4c10dc03228b (current) | 0 | 1 | 2 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
92b7bfe588c4 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
fe392d207918 (current) | 0 | 1 | 0 |
| 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 |
Feed
/atom/term/operator.atom carries one entry for each text of a row whose counts above differ from the row’s previous text, and one for the first text of a row holding the term, dated by the text’s first observation. A new version of the derivation is a change of method and is never an entry.
How this page is derived
From the terms-index derivation’s current version, first derived on
, read from
state/terms-index.jsonl. Threshold: a key enters the index when at least 1 observed text of a tracked row defines it, under the definitions derivation's current version. Its version, its rules and
term set, and the versions of the clause-anchor, definitions and sentence derivations it joins, are on
the derivation methods page, which lists every version of each with
the day it was first derived: a change there is a change of method, never a change in a text.
Not read: a term printed in a form no definition under its key carries: a plural or other ending, another letter case, another spacing or a line break between its words, a hyphenated or abbreviated form, a translation; a term a document defines in a form head 3's rules do not read (its own not_reached names them), which enters no key; an occurrence in a text head 1 refused, which is not read; a title is read for its row and is not dated by a text. A position states where an occurrence lies in a text and nothing about what the text says of the term.
| Entry | text_retained | licence_class | quote_allowed | snapshot_available |
|---|---|---|---|---|
| EU AI Act | true | open | true | true |
| EU Machinery Regulation | true | open | true | true |
| EU MDR | true | open | true | true |
| EU IVDR | true | open | true | true |
| EU Cybersecurity Act | true | open | true | true |
| 21 CFR Part 11 | true | open | true | true |
| EU Cyber Resilience Act | true | open | true | true |
| EU GMP Annex 22 | true | open | true | true |
| FDA device cybersecurity | true | open | true | true |
| FDA device cybersecurity (2026) | true | open | true | true |
| EU GMP Annex 11 | true | open | true | true |
| 21 CFR Part 820 (QMSR) | true | open | true | true |
| EU NIS2 Directive | 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: