entity
shared term, no equivalence asserted
The rows below print this term in 3 jurisdictions, set side by side by each row’s own jurisdiction field, in code-unit order of that field. Each definition is kept apart under its own text, and quoted where the term and its text together sit under the quote cap: 0 of 1 definition in this view are quoted and 1 is withheld with the reason. No reading here says that two of them agree or differ.
EU
- Defined in
- EU NIS2 Directive
chapter-i/article-6(38): text withheld (over the cap: its term and text are 35 words) - Rows printing it in a normative sentence
- 11
- Rows printing it in a title
- 0
- Rows printing it in body
- 6
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
- 1
US
- Defined in
- no current text of a row of this jurisdiction defines it
- Rows printing it in a normative sentence
- 2
- Rows printing it in a title
- 0
- Rows printing it in body
- 3
This form is printed by the
tracked documents, each as a document defines it. The index’s key is
entity (the definitions derivation’s fold:
case set aside, spaces collapsed; each form is matched exactly as printed).
1 observed text defines it.
Counts below are over each row’s current text, the
81 of 126 current
texts the derivation read; a title is read for every one of the 132 tracked rows.
Defined
1 definition in 1 current text, as the definitions derivation’s rules read them, quoted where the term and its text together sit under the quote cap.
- EU NIS2 Directive
EUtext first observedchapter-i/article-6(38)entity: text withheld (over the cap: its term and text are 35 words)
In normative sentences
138 sentences in 14 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 data quality framework
EU1 sentence; text first observed10: 1 sentence (must) - EU AI Act
EU7 sentences; text first observedno clause anchor before this sentence: 5 sentences (should, may) ·chapter-i/article-2/3: 1 sentence (shall) ·chapter-i/article-3: 1 sentence (may, shall) - EU Cyber Resilience Act
EU7 sentences; text first observedno clause anchor before this sentence: 4 sentences (should, may) ·chapter-ii/article-13/6: 2 sentences (shall) ·chapter-iv/article-36/3: 1 sentence (shall) - EU Cybersecurity Act
EU1 sentence; text first observedtitle-iv/article-69/6: 1 sentence (shall) - EU GMP Annex 19
EU1 sentence; text first observed6.1: 1 sentence (should) - EU GMP Chapter 4 (draft)
EU1 sentence; text first observedno numbering read: 1 sentence (may, should) - EU GMP Chapter 5
EU1 sentence; text first observedpart-1: 1 sentence (shall) - EU IVDR
EU11 sentences; text first observedchapter-ii/article-5/5: 1 sentence (shall) ·chapter-iii/article-24/2: 3 sentences (shall) ·chapter-iii/article-24/3: 1 sentence (shall) ·chapter-iii/article-26/1: 1 sentence (shall) ·chapter-vi/article-58/5: 1 sentence (may) ·annex-vi/part-c/4.8: 1 sentence (shall) ·annex-vii/1.1.2: 1 sentence (shall) ·annex-vii/1.1.3: 1 sentence (shall) ·annex-vii/1.2.6: 1 sentence (shall) - EU Machinery Regulation
EU1 sentence; text first observedchapter-v/article-27/3: 1 sentence (shall) - EU MDR
EU12 sentences; text first observedchapter-ii/article-5/5: 1 sentence (shall) ·chapter-iii/article-27/2: 3 sentences (shall) ·chapter-iii/article-27/3: 1 sentence (shall) ·chapter-iii/article-29/1: 1 sentence (shall) ·chapter-iii/article-29/2: 1 sentence (shall) ·chapter-vi/article-62/4: 1 sentence (may) ·annex-vi/part-c/4.8: 1 sentence (shall) ·annex-vii/1.1.2: 1 sentence (shall) ·annex-vii/1.1.3: 1 sentence (shall) ·annex-vii/1.2.6: 1 sentence (shall) - EU NIS2 Directive
EU85 sentences; text first observedno clause anchor before this sentence: 37 sentences (should, may) ·chapter-i/article-2/9: 1 sentence (shall) ·chapter-i/article-3/4: 1 sentence (shall) ·chapter-i/article-6: 1 sentence (may) ·chapter-ii/article-10/1: 1 sentence (shall) ·chapter-ii/article-11/3: 1 sentence (shall) ·chapter-iv/article-20/2: 1 sentence (shall) ·chapter-iv/article-21/1: 1 sentence (shall) ·chapter-iv/article-21/2: 1 sentence (shall) ·chapter-iv/article-21/4: 1 sentence (shall) ·chapter-iv/article-23/1: 1 sentence (shall) ·chapter-iv/article-23/3: 1 sentence (shall) ·chapter-iv/article-23/5: 2 sentences (shall) ·chapter-iv/article-23/6: 1 sentence (shall) ·chapter-iv/article-23/7: 1 sentence (may) ·chapter-iv/article-24/1: 1 sentence (may) ·chapter-v/article-26/2: 2 sentences (shall) ·chapter-v/article-26/3: 3 sentences (shall, may) ·chapter-v/article-26/4: 1 sentence (shall) ·chapter-v/article-26/5: 1 sentence (may) ·chapter-v/article-27/2: 1 sentence (shall) ·chapter-vi/article-30/2: 2 sentences (shall) ·chapter-vii/article-32/2: 3 sentences (shall) ·chapter-vii/article-32/5: 3 sentences (shall) ·chapter-vii/article-32/6: 1 sentence (shall) ·chapter-vii/article-32/7: 1 sentence (shall) ·chapter-vii/article-32/9: 2 sentences (shall, may) ·chapter-vii/article-32/10: 1 sentence (shall) ·chapter-vii/article-33/1: 1 sentence (shall) ·chapter-vii/article-33/2: 3 sentences (shall) ·chapter-vii/article-33/6: 1 sentence (shall) ·chapter-vii/article-34/4: 1 sentence (shall) ·chapter-vii/article-34/5: 1 sentence (shall) ·chapter-vii/article-34/6: 1 sentence (may) ·chapter-vii/article-35/1: 1 sentence (shall) ·chapter-vii/article-37/1: 1 sentence (shall) ·chapter-ix/article-40: 1 sentence (shall) - FDA AI guidance
US3 sentences; text first observed7: 3 sentences (may) - FDA electronic systems (clinical)
US6 sentences; text first observedno clause anchor before this sentence: 6 sentences (should, may) - ICH Q9(R1)
International1 sentence; text first observed8: 1 sentence (may)
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
37 occurrences in 10 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 data quality framework
EU6 occurrences; text first observed10: 6 - EU AI Act
EU2 occurrences; text first observedchapter-i/article-2/3: 2 - EU Cyber Resilience Act
EU3 occurrences; text first observed3 where no heading is read before it - EU GMP Annex 13
EU1 occurrence; text first observed5: 1 - EU GMP Annex 2
EU1 occurrence; text first observed36: 1 - EU NIS2 Directive
EU16 occurrences; text first observedannex-i: 1 ·annex-ii: 1 ·chapter-i/article-2/2: 6 · 8 where no heading is read before it - FDA AI guidance
US1 occurrence; text first observed7: 1 - FDA device cybersecurity (2026)
US5 occurrences; text first observed6: 5 - FDA electronic systems (clinical)
US1 occurrence; text first observed1 where no heading is read before it - ICH Q13
International1 occurrence; text first observed1 where the heading before it is withheld
Co-occurrence
179 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. 66 positions of this term have no placed clause and share none (a defining occurrence inside a sentence above is counted once under each).
- accreditation 1 clause:
eu-ivdrchapter-ii/article-5/5 - Act 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - adverse event 2 clauses:
ema-data-quality-framework10;eu-gmp-annex-236 - Agency 4 clauses:
ema-data-quality-framework10;eu-nis2chapter-i/article-3/4;fda-ai-guidance7;fda-device-cybersecurity-20266 - AI literacy 1 clause:
eu-ai-actchapter-i/article-3 - AI Office 1 clause:
eu-ai-actchapter-i/article-3 - AI regulatory sandbox 1 clause:
eu-ai-actchapter-i/article-3 - AI system 1 clause:
eu-ai-actchapter-i/article-3 - allow-list 1 clause:
fda-device-cybersecurity-20266 - analytical performance 1 clause:
eu-ivdrchapter-vi/article-58/5 - Application 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - Audits 1 clause:
eu-gmp-chapter-5part-1 - authorised representative 1 clause:
eu-ai-actchapter-i/article-3 - biometric categorisation system 1 clause:
eu-ai-actchapter-i/article-3 - biometric data 1 clause:
eu-ai-actchapter-i/article-3 - biometric identification 1 clause:
eu-ai-actchapter-i/article-3 - biometric verification 1 clause:
eu-ai-actchapter-i/article-3 - CE marking 1 clause:
eu-ai-actchapter-i/article-3 - chains 2 clauses:
eu-gmp-annex-236;ich-q9r18 - clinical evaluation 1 clause:
eu-mdrchapter-vi/article-62/4 - clinical investigation 2 clauses:
eu-mdrchapter-vi/article-62/4;fda-ai-guidance7 - clinical investigation plan 1 clause:
eu-mdrchapter-vi/article-62/4 - clinical performance 1 clause:
eu-ivdrchapter-vi/article-58/5 - Closed system 1 clause:
eu-gmp-annex-236 - cloud computing service 1 clause:
eu-nis2chapter-i/article-6 - common specification 1 clause:
eu-ai-actchapter-i/article-3 - Component / component 6 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-ii/article-13/6;eu-gmp-annex-236;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18 - conformity assessment 4 clauses:
eu-ai-actchapter-i/article-3;eu-cybersecurity-acttitle-iv/article-69/6;eu-ivdrannex-vii/1.1.3;eu-mdrannex-vii/1.1.3 - conformity assessment body 2 clauses:
eu-ai-actchapter-i/article-3;eu-cybersecurity-acttitle-iv/article-69/6 - content delivery network 1 clause:
eu-nis2chapter-i/article-6 - corrective action 1 clause:
fda-device-cybersecurity-20266 - critical infrastructure 1 clause:
eu-ai-actchapter-i/article-3 - custom-made device 3 clauses:
eu-mdrchapter-iii/article-27/3·chapter-iii/article-29/1·chapter-iii/article-29/2 - cyber threat 2 clauses:
eu-nis2chapter-i/article-6;fda-device-cybersecurity-20266 - cybersecurity 13 clauses:
eu-cybersecurity-acttitle-iv/article-69/6;eu-nis2chapter-i/article-6·chapter-ii/article-11/3·chapter-iv/article-20/2·chapter-iv/article-21/2·chapter-iv/article-24/1·chapter-ix/article-40·chapter-v/article-26/2·chapter-vii/article-32/2·chapter-vii/article-32/7·chapter-vii/article-33/2;fda-ai-guidance7;fda-device-cybersecurity-20266 - cybersecurity risk 9 clauses:
eu-nis2chapter-i/article-6·chapter-iv/article-20/2·chapter-iv/article-21/2·chapter-v/article-26/2·chapter-vii/article-32/2·chapter-vii/article-32/7·chapter-vii/article-33/2;fda-ai-guidance7;fda-device-cybersecurity-20266 - data centre service 1 clause:
eu-nis2chapter-i/article-6 - deep fake 1 clause:
eu-ai-actchapter-i/article-3 - deployer 1 clause:
eu-ai-actchapter-i/article-3 - device for performance study 1 clause:
eu-ivdrchapter-iii/article-24/3 - device software function 1 clause:
fda-device-cybersecurity-20266 - digital service 1 clause:
eu-nis2chapter-i/article-6 - distributor 1 clause:
eu-ai-actchapter-i/article-3 - DNS 1 clause:
eu-nis2chapter-i/article-6 - DNS service provider 1 clause:
eu-nis2chapter-i/article-6 - domain name system 2 clauses:
eu-nis2chapter-i/article-2/2·chapter-i/article-6 - downstream provider 1 clause:
eu-ai-actchapter-i/article-3 - electronic communications service 1 clause:
eu-nis2chapter-i/article-6 - emotion recognition system 1 clause:
eu-ai-actchapter-i/article-3 - end-to-end 1 clause:
fda-device-cybersecurity-20266 - entity providing domain name registration services 1 clause:
eu-nis2chapter-i/article-6 - ethics committee 2 clauses:
eu-ivdrchapter-vi/article-58/5;eu-mdrchapter-vi/article-62/4 - Federal Food, Drug, and Cosmetic Act 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - floating-point operation 1 clause:
eu-ai-actchapter-i/article-3 - general-purpose AI model 1 clause:
eu-ai-actchapter-i/article-3 - general-purpose AI system 1 clause:
eu-ai-actchapter-i/article-3 - hardware 2 clauses:
eu-cyber-resilience-actchapter-ii/article-13/6;fda-device-cybersecurity-20266 - Harm 1 clause:
fda-device-cybersecurity-20266 - harmonised standard 1 clause:
eu-ai-actchapter-i/article-3 - Hazard / hazard 1 clause:
ich-q9r18 - Hazard Identification 1 clause:
ich-q9r18 - health institution 2 clauses:
eu-ivdrchapter-ii/article-5/5;eu-mdrchapter-ii/article-5/5 - high-impact capabilities 1 clause:
eu-ai-actchapter-i/article-3 - ICT process 1 clause:
eu-nis2chapter-i/article-6 - ICT product 1 clause:
eu-nis2chapter-i/article-6 - ICT service 1 clause:
eu-nis2chapter-i/article-6 - identity management 1 clause:
fda-device-cybersecurity-20266 - importer 2 clauses:
eu-ai-actchapter-i/article-3;eu-gmp-chapter-5part-1 - incident 13 clauses:
eu-ai-actchapter-i/article-3;eu-gmp-annex-236;eu-nis2chapter-i/article-6·chapter-ii/article-10/1·chapter-ii/article-11/3·chapter-iv/article-21/2·chapter-iv/article-23/1·chapter-iv/article-23/3·chapter-iv/article-23/5·chapter-iv/article-23/6·chapter-iv/article-23/7·chapter-vii/article-32/2;fda-device-cybersecurity-20266 - incident handling 3 clauses:
eu-nis2chapter-i/article-6·chapter-ii/article-10/1·chapter-iv/article-21/2 - informed consent 4 clauses:
eu-ai-actchapter-i/article-3;eu-ivdrchapter-vi/article-58/5;eu-mdrchapter-vi/article-62/4;fda-device-cybersecurity-20266 - input data 1 clause:
eu-ai-actchapter-i/article-3 - instructions for use 1 clause:
eu-ai-actchapter-i/article-3 - intended purpose 4 clauses:
eu-ai-actchapter-i/article-3;eu-ivdrchapter-ii/article-5/5·chapter-vi/article-58/5;eu-mdrchapter-ii/article-5/5 - intended use 5 clauses:
ema-data-quality-framework10;eu-gmp-annex-236;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18 - internet exchange point 1 clause:
eu-nis2chapter-i/article-6 - investigational device 2 clauses:
eu-mdrchapter-iii/article-27/3·chapter-vi/article-62/4 - label 1 clause:
eu-gmp-chapter-5part-1 - large-scale cybersecurity incident 1 clause:
eu-nis2chapter-i/article-6 - law enforcement 2 clauses:
eu-ai-actchapter-i/article-3;eu-nis2chapter-iv/article-23/5 - law enforcement authority 1 clause:
eu-ai-actchapter-i/article-3 - making available on the market 1 clause:
eu-ai-actchapter-i/article-3 - managed security service provider 1 clause:
eu-nis2chapter-i/article-6 - managed service provider 1 clause:
eu-nis2chapter-i/article-6 - manufacturer 10 clauses:
eu-ai-actchapter-i/article-3;eu-gmp-annex-135;eu-gmp-annex-236;eu-gmp-chapter-5part-1;eu-ivdrchapter-iii/article-24/3·chapter-iii/article-26/1;eu-mdrchapter-iii/article-27/3·chapter-iii/article-29/1;fda-ai-guidance7;fda-device-cybersecurity-20266 - market surveillance 1 clause:
eu-ai-actchapter-i/article-3 - market surveillance authority 1 clause:
eu-ai-actchapter-i/article-3 - medical device 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - Metadata 1 clause:
ema-data-quality-framework10 - national competent authority 2 clauses:
eu-ai-actchapter-i/article-3;eu-gmp-annex-236 - national cybersecurity strategy 1 clause:
eu-nis2chapter-i/article-6 - near miss 1 clause:
eu-nis2chapter-i/article-6 - network and information system 2 clauses:
eu-nis2chapter-i/article-6·chapter-v/article-26/5 - non-personal data 1 clause:
eu-ai-actchapter-i/article-3 - notified body 7 clauses:
eu-ai-actchapter-i/article-3;eu-ivdrannex-vii/1.1.2·annex-vii/1.1.3·annex-vii/1.2.6;eu-mdrannex-vii/1.1.2·annex-vii/1.1.3·annex-vii/1.2.6 - notifying authority 3 clauses:
eu-ai-actchapter-i/article-3;eu-cyber-resilience-actchapter-iv/article-36/3;eu-machinery-regulationchapter-v/article-27/3 - online marketplace 1 clause:
eu-nis2chapter-i/article-6 - online search engine 1 clause:
eu-nis2chapter-i/article-6 - operator 3 clauses:
eu-ai-actchapter-i/article-3;eu-gmp-annex-236;fda-device-cybersecurity-20266 - performance 12 clauses:
ema-data-quality-framework10;eu-ai-actchapter-i/article-3;eu-gmp-annex-236;eu-gmp-chapter-5part-1;eu-ivdrchapter-ii/article-5/5·chapter-iii/article-24/3·chapter-vi/article-58/5;eu-mdrchapter-ii/article-5/5·chapter-vi/article-62/4;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18 - performance of an AI system 1 clause:
eu-ai-actchapter-i/article-3 - performance study 2 clauses:
eu-ivdrchapter-iii/article-24/3·chapter-vi/article-58/5 - performance study plan 1 clause:
eu-ivdrchapter-vi/article-58/5 - personal data 2 clauses:
eu-ai-actchapter-i/article-3;eu-nis2chapter-vii/article-35/1 - placing on the market 2 clauses:
eu-ai-actchapter-i/article-3;eu-mdrchapter-iii/article-29/2 - post-market monitoring system 1 clause:
eu-ai-actchapter-i/article-3 - post-remote biometric identification system 1 clause:
eu-ai-actchapter-i/article-3 - procedure pack 1 clause:
eu-mdrchapter-iii/article-29/2 - Product Lifecycle 2 clauses:
fda-ai-guidance7;ich-q9r18 - product with digital elements 1 clause:
eu-cyber-resilience-actchapter-ii/article-13/6 - profiling 1 clause:
eu-ai-actchapter-i/article-3 - provider 8 clauses:
ema-data-quality-framework10;eu-ai-actchapter-i/article-3;eu-nis2chapter-i/article-2/2·chapter-i/article-2/9·chapter-i/article-6·chapter-vii/article-32/10·chapter-vii/article-33/6;fda-device-cybersecurity-20266 - public administration entity 2 clauses:
eu-nis2chapter-i/article-2/2·chapter-i/article-6 - public electronic communications network 1 clause:
eu-nis2chapter-i/article-6 - publicly accessible space 1 clause:
eu-ai-actchapter-i/article-3 - putting into service 1 clause:
eu-ai-actchapter-i/article-3 - qualified trust service 1 clause:
eu-nis2chapter-i/article-6 - qualified trust service provider 1 clause:
eu-nis2chapter-i/article-6 - Quality 6 clauses:
ema-data-quality-framework10;eu-gmp-annex-236;eu-gmp-chapter-5part-1;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18 - Quality Risk Management 3 clauses:
eu-gmp-chapter-5part-1;fda-ai-guidance7;ich-q9r18 - Quality System 4 clauses:
ema-data-quality-framework10;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18 - real-time remote biometric identification system 1 clause:
eu-ai-actchapter-i/article-3 - real-world testing plan 1 clause:
eu-ai-actchapter-i/article-3 - reasonably foreseeable misuse 2 clauses:
eu-ai-actchapter-i/article-3;fda-device-cybersecurity-20266 - recall 5 clauses:
eu-ai-actchapter-i/article-3;eu-gmp-annex-236;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18 - 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 - representative 13 clauses:
ema-data-quality-framework10;eu-ai-actchapter-i/article-3;eu-gmp-annex-236;eu-ivdrchapter-vi/article-58/5;eu-mdrchapter-vi/article-62/4;eu-nis2chapter-i/article-6·chapter-v/article-26/3·chapter-v/article-26/4·chapter-v/article-27/2·chapter-vii/article-32/5·chapter-vii/article-32/6;fda-ai-guidance7;fda-device-cybersecurity-20266 - reprocessing 1 clause:
eu-gmp-chapter-5part-1 - Requirements 2 clauses:
ema-data-quality-framework10;fda-device-cybersecurity-20266 - research organisation 1 clause:
eu-nis2chapter-i/article-6 - Risk / risk 17 clauses:
eu-ai-actchapter-i/article-3;eu-gmp-annex-236;eu-gmp-chapter-5part-1;eu-ivdrchapter-vi/article-58/5;eu-mdrchapter-vi/article-62/4;eu-nis2chapter-i/article-2/2·chapter-i/article-6·chapter-ii/article-11/3·chapter-iv/article-20/2·chapter-iv/article-21/2·chapter-v/article-26/2·chapter-vii/article-32/2·chapter-vii/article-32/7·chapter-vii/article-33/2;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18 - Risk Acceptance 1 clause:
ich-q9r18 - Risk Analysis 1 clause:
ich-q9r18 - Risk Assessment 3 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18 - Risk Control 1 clause:
ich-q9r18 - Risk Evaluation 1 clause:
ich-q9r18 - Risk Management 4 clauses:
eu-gmp-chapter-5part-1;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18 - Risk Reduction 1 clause:
ich-q9r18 - Risk Review 1 clause:
ich-q9r18 - safety component 1 clause:
eu-ai-actchapter-i/article-3 - safety function 1 clause:
eu-ai-actchapter-i/article-3 - sandbox plan 1 clause:
eu-ai-actchapter-i/article-3 - security of network and information systems 2 clauses:
eu-nis2chapter-i/article-6·chapter-iv/article-21/1 - sensitive operational data 1 clause:
eu-ai-actchapter-i/article-3 - serious adverse event 1 clause:
eu-gmp-annex-236 - serious incident 1 clause:
eu-ai-actchapter-i/article-3 - significant cyber threat 1 clause:
eu-nis2chapter-i/article-6 - significant cybersecurity risk 1 clause:
fda-device-cybersecurity-20266 - social networking services platform 1 clause:
eu-nis2chapter-i/article-6 - software 4 clauses:
ema-data-quality-framework10;eu-cyber-resilience-actchapter-ii/article-13/6;fda-ai-guidance7;fda-device-cybersecurity-20266 - source code 1 clause:
fda-device-cybersecurity-20266 - special categories of personal data 1 clause:
eu-ai-actchapter-i/article-3 - sponsor 5 clauses:
eu-gmp-annex-135;eu-ivdrchapter-vi/article-58/5;eu-mdrchapter-vi/article-62/4;fda-ai-guidance7;fda-device-cybersecurity-20266 - standard 7 clauses:
ema-data-quality-framework10;eu-ai-actchapter-i/article-3;eu-ivdrchapter-ii/article-5/5;eu-nis2chapter-i/article-6;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18 - subject 18 clauses:
ema-data-quality-framework10;eu-ai-actchapter-i/article-3;eu-gmp-annex-236;eu-ivdrannex-vii/1.1.3·chapter-vi/article-58/5;eu-mdrannex-vii/1.1.3·chapter-vi/article-62/4;eu-nis2chapter-i/article-6·chapter-iv/article-23/1·chapter-vi/article-30/2·chapter-vii/article-32/2·chapter-vii/article-32/5·chapter-vii/article-33/2·chapter-vii/article-34/4·chapter-vii/article-34/5;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18 - substantial modification 1 clause:
eu-ai-actchapter-i/article-3 - Supervisor 1 clause:
eu-ai-actchapter-i/article-3 - System / system 14 clauses:
ema-data-quality-framework10;eu-ai-actchapter-i/article-3;eu-gmp-annex-236;eu-gmp-chapter-5part-1;eu-ivdrchapter-iii/article-24/2;eu-mdrchapter-iii/article-27/2·chapter-iii/article-29/2;eu-nis2chapter-i/article-2/2·chapter-i/article-6·chapter-iv/article-21/2·chapter-v/article-26/5;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r18 - systemic risk 2 clauses:
eu-ai-actchapter-i/article-3;eu-nis2chapter-i/article-2/2 - technical specification 1 clause:
eu-nis2chapter-i/article-6 - technical specifications 1 clause:
eu-ai-actchapter-i/article-3 - testing data 1 clause:
eu-ai-actchapter-i/article-3 - testing in real-world conditions 1 clause:
eu-ai-actchapter-i/article-3 - TLD name registry 1 clause:
eu-nis2chapter-i/article-6 - top-level domain name registry 1 clause:
eu-nis2chapter-i/article-6 - training data 2 clauses:
eu-ai-actchapter-i/article-3;fda-ai-guidance7 - trust service 3 clauses:
eu-nis2chapter-i/article-2/2·chapter-i/article-2/9·chapter-i/article-6 - trust service provider 2 clauses:
eu-nis2chapter-i/article-2/9·chapter-i/article-6 - UDI 10 clauses:
eu-ivdrannex-vi/part-c/4.8·chapter-iii/article-24/2·chapter-iii/article-24/3·chapter-iii/article-26/1;eu-mdrannex-vi/part-c/4.8·chapter-iii/article-27/2·chapter-iii/article-27/3·chapter-iii/article-29/1·chapter-iii/article-29/2;fda-device-cybersecurity-20266 - Union harmonisation legislation 1 clause:
eu-ai-actchapter-i/article-3 - user 3 clauses:
eu-nis2chapter-i/article-6;fda-ai-guidance7;fda-device-cybersecurity-20266 - validation data 1 clause:
eu-ai-actchapter-i/article-3 - validation data set 1 clause:
eu-ai-actchapter-i/article-3 - vulnerability 5 clauses:
eu-cyber-resilience-actchapter-ii/article-13/6;eu-nis2chapter-i/article-6·chapter-ii/article-11/3·chapter-iv/article-21/2;fda-device-cybersecurity-20266 - widespread infringement 1 clause:
eu-ai-actchapter-i/article-3 - withdrawal 1 clause:
eu-ai-actchapter-i/article-3 - withdrawal of an AI system 1 clause:
eu-ai-actchapter-i/article-3 - written 4 clauses:
eu-ai-actchapter-i/article-3;eu-gmp-annex-196.1;eu-gmp-annex-236;eu-gmp-chapter-5part-1
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 |
|---|---|---|---|---|
e2ad4536a9bd unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
4d30b7bae7dd (current) | 0 | 1 | 6 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
58dbc3006d27 | 0 | 7 | 2 | |
9d16077b1d3b (current) | 0 | 7 | 2 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
9206a43954eb (current) | 0 | 7 | 3 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
1fe6027daa2c (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 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
4aafde337ab3 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
fecd3a76fef8 (current) | 0 | 1 | 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 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
85a680107f4d unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
8f04120f403b (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
f30eb798ed40 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
172395cf624f (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
903e40aaebe6 (current) | 0 | 11 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
1fc20ae2ffd8 | 0 | 1 | 0 | |
82fb682a6c54 (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
14d00b77d5c8 | 0 | 12 | 0 | |
fab624c8e1dc (current) | 0 | 12 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
023dc18395dc (current) | 1 | 85 | 16 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
61d4603ff66e | 0 | 0 | 0 | |
088a7a37c55d | 0 | 0 | 0 | |
630bd27c7b42 | 0 | 0 | 84 | |
5c61f4c6351d (current) | 0 | 3 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
b52b706d5cca (current) | 0 | 0 | 0 | |
d34d8c706d88 | 0 | 0 | 5 |
| 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 | 0 | 5 |
| 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 | 6 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
06273204f50b (current) | 0 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
57c484f5daed (current) | 0 | 1 | 0 |
Feed
/atom/term/entity.atom carries one entry for each text of a row whose counts above differ from the row’s previous text, and one for the first text of a row holding the term, dated by the text’s first observation. A new version of the derivation is a change of method and is never an entry.
How this page is derived
From the terms-index derivation’s current version, first derived on
, read from
state/terms-index.jsonl. Threshold: a key enters the index when at least 1 observed text of a tracked row defines it, under the definitions derivation's current version. Its version, its rules and
term set, and the versions of the clause-anchor, definitions and sentence derivations it joins, are on
the derivation methods page, which lists every version of each with
the day it was first derived: a change there is a change of method, never a change in a text.
Not read: a term printed in a form no definition under its key carries: a plural or other ending, another letter case, another spacing or a line break between its words, a hyphenated or abbreviated form, a translation; a term a document defines in a form head 3's rules do not read (its own not_reached names them), which enters no key; an occurrence in a text head 1 refused, which is not read; a title is read for its row and is not dated by a text. A position states where an occurrence lies in a text and nothing about what the text says of the term.
| Entry | text_retained | licence_class | quote_allowed | snapshot_available |
|---|---|---|---|---|
| EU NIS2 Directive | true | open | true | true |
| EU Cybersecurity Act | true | open | true | true |
| EU Machinery Regulation | true | open | true | true |
| 21 CFR Part 11 | true | open | true | true |
| EU IVDR | true | open | true | true |
| EU MDR | true | open | true | true |
| EU AI Act | true | open | true | true |
| EU GMP Annex 22 | true | open | true | true |
| FDA device cybersecurity | true | open | true | true |
| FDA device cybersecurity (2026) | true | open | true | true |
| EU GMP Annex 11 | true | open | true | true |
| FDA electronic systems (clinical) | true | open | true | true |
| EU Cyber Resilience Act | true | open | true | true |
| 21 CFR Part 820 (QMSR) | true | open | true | true |
| ICH Q9(R1) | true | open | true | true |
| Regulation (EU) 2026/1744 | true | open | true | true |
| ICH Q13 | true | open | true | true |
| EU GMP Chapter 4 | true | open | true | true |
One row for each entry whose own characters this page prints: a text defining a form printed here, or a definition quoted. A row named or linked without its characters printed, or whose title only or sentence clauses only are given, has no row.
Each value is read by the same function the API reads, and each field is defined in the published schema. None of the four is a grant.
Last updated: