user
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: 2 of 2 definitions in this view are quoted and 0 are withheld with the reason. No reading here says that two of them agree or differ.
EU
- Defined in
- EU IVDR
chapter-i/section-1/article-2(30): any healthcare professional or lay person who uses a device;EU MDRchapter-i/article-2(37): any healthcare professional or lay person who uses a device; - Rows printing it in a normative sentence
- 16
- Rows printing it in a title
- 0
- Rows printing it in body
- 11
International
- Defined in
- no current text of a row of this jurisdiction defines it
- Rows printing it in a normative sentence
- 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
- 5
- Rows printing it in a title
- 0
- Rows printing it in body
- 4
This form is printed by the
tracked documents, each as a document defines it. The index’s key is
user (the definitions derivation’s fold:
case set aside, spaces collapsed; each form is matched exactly as printed).
3 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 IVDR
EUtext first observedchapter-i/section-1/article-2(30)user: any healthcare professional or lay person who uses a device;
- EU MDR
EUtext first observedchapter-i/article-2(37)user: any healthcare professional or lay person who uses a device;
In normative sentences
266 sentences in 22 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.
- Annex 11 concept paper
EU7 sentences; text first observed1: 7 sentences (should, may) - EMA CT computerised systems
EU30 sentences; text first observedid repeats in this text: 1 sentence (should) · follows a withheld heading: 2 sentences (should) · id repeats in this text: 27 sentences (should, may) - EU AI Act
EU2 sentences; text first observedno clause anchor before this sentence: 1 sentence (should) ·chapter-viii/article-71/4: 1 sentence (shall) - EU Cyber Resilience Act
EU22 sentences; text first observedno clause anchor before this sentence: 7 sentences (should, may) ·chapter-ii/article-13/8: 1 sentence (shall, is expected) ·chapter-ii/article-13/11: 1 sentence (may) ·chapter-ii/article-13/16: 1 sentence (shall) ·chapter-ii/article-13/17: 1 sentence (shall) ·chapter-ii/article-13/18: 3 sentences (shall) ·chapter-ii/article-14/5: 1 sentence (shall) ·chapter-ii/article-19/2: 1 sentence (shall) ·chapter-iv/article-39/4: 1 sentence (shall) ·chapter-v/article-52/16: 1 sentence (shall) ·annex-i/part-i: 1 sentence (shall) ·annex-i/part-ii: 1 sentence (shall, may) ·annex-ii: 1 sentence (shall, may) ·annex-vii: 1 sentence (shall) - EU Cybersecurity Act
EU9 sentences; text first observedno clause anchor before this sentence: 8 sentences (should) ·title-iv/article-69/4: 1 sentence (shall) - Regulation (EU) 2026/1744
EU1 sentence; text first observedarticle-1/3: 1 sentence (shall) - EU GMP Annex 1
EU4 sentences; text first observedannex-1/11: 4 sentences (should) - EU GMP Annex 11
EU2 sentences; text first observed3.3: 1 sentence (should) ·4.5: 1 sentence (should) - EU GMP Annex 11 (draft)
EU29 sentences; text first observed17: 29 sentences (should, may, must) - EU GMP Annex 15
EU2 sentences; text first observed3.1: 1 sentence (should) ·3.3: 1 sentence (should) - EU GMP Annex 22
EU1 sentence; text first observed10: 1 sentence (should) - EU GMP Chapter 4 (draft)
EU14 sentences; text first observedno numbering read: 14 sentences (should) - EU IVDR
EU44 sentences; text first observedno clause anchor before this sentence: 2 sentences (should) ·chapter-i/section-1/article-2: 1 sentence (shall, may) ·chapter-ii/article-7: 1 sentence (shall, may) ·chapter-ii/article-10/10: 3 sentences (shall) ·chapter-ii/article-10/13: 1 sentence (shall) ·chapter-iii/article-29/1: 1 sentence (shall) ·chapter-vi/article-57/1: 1 sentence (shall) ·chapter-vi/article-59/6: 1 sentence (shall) ·chapter-vi/article-69/5: 1 sentence (shall) ·chapter-vi/article-71/3: 1 sentence (may) ·chapter-vi/article-73/5: 1 sentence (shall) ·annex-i/chapter-i/6: 1 sentence (shall) ·annex-i/chapter-i/8: 1 sentence (shall) ·annex-i/chapter-ii: 10 sentences (shall) ·annex-i/chapter-iii: 11 sentences (shall, may, should) ·annex-ii/1.1: 1 sentence (may) ·annex-ii/6.4: 1 sentence (shall) ·annex-vi/part-c/5.10: 1 sentence (shall) ·annex-vi/part-c/6.2.4: 2 sentences (shall) ·annex-ix/chapter-ii: 1 sentence (shall) ·annex-xiii/part-a/2.3.2: 1 sentence (shall) - EU Machinery Regulation
EU14 sentences; text first observedno clause anchor before this sentence: 4 sentences (should) ·chapter-i/article-3: 1 sentence (may) ·chapter-ii/article-10/7: 2 sentences (shall) ·chapter-ii/article-18: 1 sentence (shall) ·chapter-v/article-30/4: 1 sentence (shall) ·annex-iii/part-b/5: 3 sentences (shall, should, must, may) ·annex-vii/3: 1 sentence (shall) ·annex-xi/2: 1 sentence (shall, must, may, should) - EU MDR
EU51 sentences; text first observedno clause anchor before this sentence: 2 sentences (should) ·chapter-i/article-2: 2 sentences (shall, may) ·chapter-ii/article-7: 1 sentence (shall, may) ·chapter-ii/article-10/11: 2 sentences (shall) ·chapter-ii/article-10/14: 1 sentence (shall) ·chapter-ii/article-21/2: 1 sentence (shall) ·chapter-iii/article-28/4: 1 sentence (shall) ·chapter-iii/article-32/1: 1 sentence (shall) ·chapter-iii/article-33/5: 1 sentence (shall) ·chapter-vi/article-63/6: 1 sentence (shall) ·chapter-vi/article-73/5: 1 sentence (shall) ·chapter-vi/article-75/3: 1 sentence (may) ·chapter-vi/article-77/5: 1 sentence (shall) ·annex-i/chapter-i/6: 1 sentence (shall) ·annex-i/chapter-i/8: 1 sentence (shall) ·annex-i/chapter-ii: 14 sentences (shall) ·annex-i/chapter-iii: 11 sentences (shall, may, should) ·annex-ii/1.1: 1 sentence (shall) ·annex-ii/6.1: 1 sentence (shall) ·annex-vi/part-c/5.10: 1 sentence (shall) ·annex-vi/part-c/6.5.4: 2 sentences (shall) ·annex-ix/chapter-ii: 1 sentence (shall) ·annex-xiii/1: 1 sentence (shall) ·annex-xiv/part-a/3: 1 sentence (shall) - EU NIS2 Directive
EU3 sentences; text first observedno clause anchor before this sentence: 2 sentences (should) ·chapter-i/article-6: 1 sentence (may) - FDA AI guidance
US1 sentence; text first observed7: 1 sentence (may) - FDA device cybersecurity (2026)
US15 sentences; text first observed6: 15 sentences (should, may) - FDA electronic systems (clinical)
US8 sentences; text first observedno clause anchor before this sentence: 8 sentences (should, must) - NIST AI 600-1
US2 sentences; text first observed12: 2 sentences (may) - NIST AI RMF
International4 sentences; text first observed3.4: 1 sentence (should) ·3.5: 1 sentence (may) ·5: 1 sentence (may) ·6: 1 sentence (may) - NIST AI RMF Playbook
US1 sentence; text first observedno numbering read: 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
109 occurrences in 17 current texts outside every sentence above and outside the term’s own definitions, each counted under the clause anchor the clause-anchor derivation placed last before it; each clause is followed by its count.
- EMA CT computerised systems
EU14 occurrences; text first observed1 where no heading is read before it · 13 where the heading before it is withheld - EU AI Act
EU3 occurrences; text first observedannex-iv/1: 2 · 1 where no heading is read before it - EU Cyber Resilience Act
EU2 occurrences; text first observedannex-ii: 1 · 1 where no heading is read before it - Regulation (EU) 2026/1744
EU2 occurrences; text first observedarticle-1/3: 1 · 1 where no heading is read before it - EU GMP Annex 11 (draft)
EU9 occurrences; text first observed17: 6 ·17.5: 3 - EU GMP Annex 15
EU1 occurrence; text first observed12: 1 - EU GMP Chapter 4 (draft)
EU5 occurrences; text first observed5 where no numbering read in this text - EU IVDR
EU4 occurrences; text first observedannex-vi/part-c/6.2.2: 1 ·chapter-i/section-1/article-2: 3 - EU Machinery Regulation
EU1 occurrence; text first observedannex-vii/4: 1 - EU MDR
EU4 occurrences; text first observedannex-i/chapter-ii: 1 ·annex-ii/6.1: 1 ·annex-vi/part-c/6.5.2: 1 ·chapter-i/article-2: 1 - EU NIS2 Directive
EU4 occurrences; text first observed4 where no heading is read before it - FDA device cybersecurity (2026)
US13 occurrences; text first observed6: 13 - FDA electronic systems (clinical)
US2 occurrences; text first observed2 where no heading is read before it - ICH Q14
International1 occurrence; text first observed1 where the heading before it is withheld - NIST AI 600-1
US23 occurrences; text first observed12: 22 ·3: 1 - NIST AI RMF
International7 occurrences; text first observed3.4: 1 ·5.2: 1 ·6: 5 - NISTIR 8183
US14 occurrences; text first observed7: 14
Co-occurrence
218 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. 108 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 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - active device 1 clause:
eu-mdrchapter-i/article-2 - adverse event 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - Agency 3 clauses:
fda-ai-guidance7;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-digital-omnibus-aiarticle-1/3 - AI system 9 clauses:
eu-ai-actannex-iv/1;eu-digital-omnibus-aiarticle-1/3;nist-ai-600-112·3;nist-ai-rmf3.4·3.5·5·5.2·6 - allow-list 1 clause:
fda-device-cybersecurity-20266 - analytical performance 4 clauses:
eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii·annex-xiii/part-a/2.3.2·chapter-i/section-1/article-2 - Application 8 clauses:
eu-gmp-annex-11-draft17.5;eu-machinery-regulationannex-iii/part-b/5·annex-vii/3;eu-mdrannex-vi/part-c/6.5.4;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-rmf6;nistir-81837 - assurance level 1 clause:
eu-gmp-annex-1annex-1/11 - authorised representative 10 clauses:
eu-cyber-resilience-actchapter-iv/article-39/4;eu-cybersecurity-acttitle-iv/article-69/4;eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·annex-vii/3·chapter-i/article-3;eu-mdrannex-i/chapter-iii·annex-xiii/1·chapter-i/article-2 - Autonomous mobile machinery 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - benefit-risk determination 4 clauses:
eu-ivdrannex-ix/chapter-ii·chapter-i/section-1/article-2;eu-mdrannex-ix/chapter-ii·chapter-i/article-2 - calibrator 1 clause:
eu-ivdrchapter-i/section-1/article-2 - Carrier 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - CE marking 4 clauses:
eu-cyber-resilience-actchapter-ii/article-19/2;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 3 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;nist-ai-600-112 - clinical benefit 4 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrannex-i/chapter-ii·annex-i/chapter-iii·chapter-i/article-2 - clinical data 5 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrannex-ii/6.1·annex-ix/chapter-ii·annex-xiv/part-a/3·chapter-i/article-2 - clinical evaluation 4 clauses:
eu-mdrannex-ii/6.1·annex-ix/chapter-ii·annex-xiv/part-a/3·chapter-i/article-2 - clinical evidence 4 clauses:
eu-ivdrannex-ix/chapter-ii·chapter-i/section-1/article-2;eu-mdrannex-ix/chapter-ii·chapter-i/article-2 - clinical investigation 6 clauses:
eu-mdrannex-i/chapter-iii·chapter-i/article-2·chapter-vi/article-63/6·chapter-vi/article-75/3·chapter-vi/article-77/5;fda-ai-guidance7 - clinical investigation plan 2 clauses:
eu-mdrchapter-i/article-2·chapter-vi/article-77/5 - clinical performance 9 clauses:
eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii·annex-xiii/part-a/2.3.2·chapter-i/section-1/article-2·chapter-vi/article-73/5;eu-mdrannex-i/chapter-iii·annex-xiv/part-a/3·chapter-i/article-2·chapter-iii/article-32/1 - Closed system 1 clause:
eu-gmp-annex-1annex-1/11 - cloud computing service 1 clause:
eu-nis2chapter-i/article-6 - companion diagnostic 4 clauses:
eu-ivdrannex-i/chapter-iii·annex-ii/1.1·annex-ix/chapter-ii·chapter-i/section-1/article-2 - Component / component 11 clauses:
eu-ai-actannex-iv/1;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17.5;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrannex-i/chapter-ii;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-600-112·3;nistir-81837 - conformity assessment 18 clauses:
eu-cyber-resilience-actchapter-ii/article-19/2·chapter-iv/article-39/4;eu-cybersecurity-acttitle-iv/article-69/4;eu-digital-omnibus-aiarticle-1/3;eu-ivdrannex-ix/chapter-ii·chapter-i/section-1/article-2·chapter-ii/article-7·chapter-iii/article-29/1;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3·chapter-ii/article-18·chapter-v/article-30/4;eu-mdrannex-i/chapter-ii·annex-ix/chapter-ii·chapter-i/article-2·chapter-ii/article-7·chapter-iii/article-32/1;nist-ai-600-112 - conformity assessment body 6 clauses:
eu-cyber-resilience-actchapter-iv/article-39/4;eu-cybersecurity-acttitle-iv/article-69/4;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3·chapter-v/article-30/4;eu-mdrchapter-i/article-2 - consumer 2 clauses:
nist-ai-600-112;nistir-81837 - content delivery network 1 clause:
eu-nis2chapter-i/article-6 - control material 1 clause:
eu-ivdrchapter-i/section-1/article-2 - corrective action 6 clauses:
eu-gmp-annex-1annex-1/11;eu-ivdrchapter-i/section-1/article-2·chapter-ii/article-10/13;eu-mdrchapter-i/article-2·chapter-ii/article-10/14;fda-device-cybersecurity-20266 - critical infrastructure 2 clauses:
nist-ai-600-112;nistir-81837 - custom-made device 3 clauses:
eu-mdrannex-i/chapter-iii·chapter-i/article-2·chapter-ii/article-21/2 - cyber threat 2 clauses:
eu-nis2chapter-i/article-6;fda-device-cybersecurity-20266 - cybersecurity 10 clauses:
eu-cyber-resilience-actannex-i/part-i·annex-ii·annex-vii·chapter-ii/article-13/8;eu-nis2chapter-i/article-6;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-600-112;nist-ai-rmf6;nistir-81837 - cybersecurity risk 7 clauses:
eu-cyber-resilience-actannex-i/part-i;eu-nis2chapter-i/article-6;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-600-112;nist-ai-rmf6;nistir-81837 - danger zone 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - data centre service 1 clause:
eu-nis2chapter-i/article-6 - deployer 2 clauses:
eu-ai-actannex-iv/1;eu-digital-omnibus-aiarticle-1/3 - derivative 4 clauses:
eu-mdrannex-i/chapter-iii·annex-ix/chapter-ii·annex-xiii/1·chapter-i/article-2 - device deficiency 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - device for near-patient testing 1 clause:
eu-ivdrchapter-i/section-1/article-2 - device for performance study 3 clauses:
eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2·chapter-vi/article-57/1 - device for self-testing 1 clause:
eu-ivdrchapter-i/section-1/article-2 - device software function 1 clause:
fda-device-cybersecurity-20266 - diagnostic sensitivity 3 clauses:
eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii·chapter-i/section-1/article-2 - diagnostic specificity 3 clauses:
eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii·chapter-i/section-1/article-2 - digital service 1 clause:
eu-nis2chapter-i/article-6 - distributor 5 clauses:
eu-cyber-resilience-actchapter-iv/article-39/4;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3·chapter-v/article-30/4;eu-mdrchapter-i/article-2 - DNS 1 clause:
eu-nis2chapter-i/article-6 - DNS service provider 1 clause:
eu-nis2chapter-i/article-6 - domain name system 1 clause:
eu-nis2chapter-i/article-6 - Driver 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - Dynamic test 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - economic operator 3 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2 - electronic communications service 1 clause:
eu-nis2chapter-i/article-6 - Electronic record 1 clause:
eu-gmp-annex-11-draft17.5 - end-to-end 1 clause:
fda-device-cybersecurity-20266 - entity 3 clauses:
eu-nis2chapter-i/article-6;fda-ai-guidance7;fda-device-cybersecurity-20266 - entity providing domain name registration services 1 clause:
eu-nis2chapter-i/article-6 - essential health and safety requirements 4 clauses:
eu-machinery-regulationannex-iii/part-b/5·annex-vii/4·annex-xi/2·chapter-i/article-3 - ethics committee 4 clauses:
eu-ivdrchapter-i/section-1/article-2·chapter-vi/article-71/3;eu-mdrchapter-i/article-2·chapter-vi/article-75/3 - European standard 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - falsified device 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - Federal Food, Drug, and Cosmetic Act 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - field safety corrective action 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 - fully refurbishing 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - generic device group 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - guard 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - Guided load 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - hardware 15 clauses:
ema-annex11-concept-paper1;eu-ai-actannex-iv/1;eu-cyber-resilience-actannex-vii;eu-gmp-annex-11-draft17·17.5;eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii·annex-ii/6.4;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-i/chapter-ii·annex-i/chapter-iii·annex-ii/6.1;fda-device-cybersecurity-20266;nist-ai-600-112;nistir-81837 - Harm 2 clauses:
fda-device-cybersecurity-20266;nist-ai-600-112 - harmonised standard 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 - Hazard / hazard 4 clauses:
eu-gmp-annex-1annex-1/11;eu-ivdrannex-i/chapter-iii;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - health institution 3 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrannex-xiii/1·chapter-i/article-2 - ICT process 2 clauses:
eu-cybersecurity-acttitle-iv/article-69/4;eu-nis2chapter-i/article-6 - ICT product 2 clauses:
eu-cybersecurity-acttitle-iv/article-69/4;eu-nis2chapter-i/article-6 - ICT service 2 clauses:
eu-cybersecurity-acttitle-iv/article-69/4;eu-nis2chapter-i/article-6 - identity management 1 clause:
fda-device-cybersecurity-20266 - implantable device 1 clause:
eu-mdrchapter-i/article-2 - importer 5 clauses:
eu-cyber-resilience-actchapter-iv/article-39/4;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3·chapter-v/article-30/4;eu-mdrchapter-i/article-2 - in vitro diagnostic medical device 2 clauses:
eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2 - incident 13 clauses:
eu-cyber-resilience-actannex-i/part-i·chapter-ii/article-14/5;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2;eu-mdrannex-i/chapter-iii·chapter-i/article-2;eu-nis2chapter-i/article-6;fda-device-cybersecurity-20266;nist-ai-600-112;nist-ai-rmf5.2;nistir-81837 - incident handling 2 clauses:
eu-nis2chapter-i/article-6;nistir-81837 - informed consent 5 clauses:
eu-ivdrannex-xiii/part-a/2.3.2·chapter-i/section-1/article-2;eu-mdrchapter-i/article-2;fda-device-cybersecurity-20266;nist-ai-600-112 - input data 2 clauses:
nist-ai-600-112·3 - instructions for use 18 clauses:
eu-ai-actannex-iv/1;eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii·annex-ix/chapter-ii·annex-xiii/part-a/2.3.2·chapter-i/section-1/article-2·chapter-ii/article-7·chapter-iii/article-29/1;eu-machinery-regulationannex-iii/part-b/5·annex-xi/2·chapter-i/article-3·chapter-ii/article-10/7;eu-mdrannex-i/chapter-ii·annex-i/chapter-iii·annex-ix/chapter-ii·chapter-i/article-2·chapter-ii/article-7·chapter-iii/article-32/1 - intended purpose 24 clauses:
eu-ai-actannex-iv/1;eu-cyber-resilience-actannex-i/part-i·annex-ii·annex-vii·chapter-ii/article-13/8;eu-digital-omnibus-aiarticle-1/3;eu-gmp-annex-1512;eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii·annex-ii/1.1·annex-ix/chapter-ii·annex-xiii/part-a/2.3.2·chapter-i/section-1/article-2·chapter-ii/article-7;eu-machinery-regulationchapter-i/article-3;eu-mdrannex-i/chapter-ii·annex-i/chapter-iii·annex-ii/1.1·annex-ii/6.1·annex-ix/chapter-ii·annex-xiv/part-a/3·chapter-i/article-2·chapter-ii/article-7;nist-ai-600-112 - intended use 14 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-2210;eu-ivdrannex-i/chapter-ii·annex-ix/chapter-ii·annex-vi/part-c/6.2.2;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-i/chapter-ii·annex-vi/part-c/6.5.2;fda-ai-guidance7;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 1 clause:
eu-gmp-annex-1annex-1/11 - internet exchange point 1 clause:
eu-nis2chapter-i/article-6 - interventional clinical performance study 1 clause:
eu-ivdrchapter-i/section-1/article-2 - invasive device 1 clause:
eu-mdrchapter-i/article-2 - investigational device 1 clause:
eu-mdrchapter-i/article-2 - investigator 3 clauses:
eu-ivdrannex-xiii/part-a/2.3.2·chapter-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 13 clauses:
eu-gmp-annex-1annex-1/11;eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii·annex-ix/chapter-ii·chapter-i/section-1/article-2·chapter-ii/article-10/10·chapter-iii/article-29/1;eu-mdrannex-i/chapter-ii·annex-i/chapter-iii·chapter-i/article-2·chapter-ii/article-10/11·chapter-iii/article-32/1;nist-ai-600-112 - large-scale cybersecurity incident 1 clause:
eu-nis2chapter-i/article-6 - lay person 3 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrannex-i/chapter-ii·chapter-i/article-2 - lifetime 12 clauses:
eu-cyber-resilience-actannex-ii·chapter-ii/article-13/8;eu-ivdrannex-i/chapter-i/6·annex-i/chapter-ii·annex-i/chapter-iii·chapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3·chapter-ii/article-10/7;eu-mdrannex-i/chapter-i/6·annex-i/chapter-iii·chapter-i/article-2 - lifting accessory 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - Lifting operation 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - likelihood ratio 2 clauses:
eu-ivdrannex-i/chapter-ii·chapter-i/section-1/article-2 - machinery 8 clauses:
eu-machinery-regulationannex-iii/part-b/5·annex-vii/3·annex-vii/4·annex-xi/2·chapter-i/article-3·chapter-ii/article-10/7·chapter-ii/article-18·chapter-v/article-30/4 - Machinery or related products for plant protection products application 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - Machinery or related products presenting risks due to their mobility 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - making available on the market 4 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrannex-i/chapter-iii·chapter-i/article-2 - managed security service provider 1 clause:
eu-nis2chapter-i/article-6 - managed service provider 1 clause:
eu-nis2chapter-i/article-6 - manufacturer 42 clauses:
eu-cyber-resilience-actannex-i/part-i·annex-i/part-ii·annex-ii·annex-vii·chapter-ii/article-13/16·chapter-ii/article-19/2·chapter-iv/article-39/4·chapter-v/article-52/16;eu-cybersecurity-acttitle-iv/article-69/4;eu-gmp-annex-1annex-1/11;eu-gmp-annex-1512;eu-ivdrannex-i/chapter-i/6·annex-i/chapter-ii·annex-i/chapter-iii·annex-ii/1.1·annex-ix/chapter-ii·annex-xiii/part-a/2.3.2·chapter-i/section-1/article-2·chapter-ii/article-10/13·chapter-iii/article-29/1·chapter-vi/article-57/1;eu-machinery-regulationannex-iii/part-b/5·annex-vii/3·annex-vii/4·chapter-i/article-3·chapter-ii/article-10/7·chapter-ii/article-18·chapter-v/article-30/4;eu-mdrannex-i/chapter-i/6·annex-i/chapter-ii·annex-i/chapter-iii·annex-ii/1.1·annex-ii/6.1·annex-ix/chapter-ii·annex-xiii/1·chapter-i/article-2·chapter-ii/article-10/14·chapter-ii/article-21/2·chapter-iii/article-32/1;fda-ai-guidance7;fda-device-cybersecurity-20266;nistir-81837 - market surveillance 12 clauses:
eu-ai-actchapter-viii/article-71/4;eu-cyber-resilience-actannex-vii·chapter-ii/article-13/16·chapter-ii/article-13/18·chapter-ii/article-13/8·chapter-ii/article-19/2·chapter-v/article-52/16;eu-ivdrannex-ix/chapter-ii·chapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrannex-ix/chapter-ii·chapter-i/article-2 - market surveillance authority 2 clauses:
eu-cyber-resilience-actannex-vii;eu-machinery-regulationchapter-i/article-3 - medical device 6 clauses:
eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2;eu-mdrannex-i/chapter-iii·chapter-i/article-2;fda-ai-guidance7;fda-device-cybersecurity-20266 - 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 cybersecurity strategy 1 clause:
eu-nis2chapter-i/article-6 - near miss 1 clause:
eu-nis2chapter-i/article-6 - negative predictive value 3 clauses:
eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii·chapter-i/section-1/article-2 - network and information system 1 clause:
eu-nis2chapter-i/article-6 - non-viable 4 clauses:
eu-gmp-annex-1annex-1/11;eu-mdrannex-i/chapter-ii·annex-ix/chapter-ii·chapter-i/article-2 - notified body 9 clauses:
eu-ivdrannex-ix/chapter-ii·chapter-i/section-1/article-2·chapter-iii/article-29/1;eu-machinery-regulationannex-vii/3·annex-vii/4·chapter-i/article-3;eu-mdrannex-ix/chapter-ii·chapter-i/article-2·chapter-iii/article-32/1 - online marketplace 1 clause:
eu-nis2chapter-i/article-6 - online search engine 1 clause:
eu-nis2chapter-i/article-6 - operator 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 - particle 3 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-1512;eu-mdrchapter-i/article-2 - partly completed machinery 4 clauses:
eu-machinery-regulationannex-iii/part-b/5·annex-xi/2·chapter-i/article-3·chapter-v/article-30/4 - performance 40 clauses:
eu-digital-omnibus-aiarticle-1/3;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17·17.5;eu-gmp-annex-1512;eu-gmp-annex-2210;eu-ivdrannex-i/chapter-i/6·annex-i/chapter-i/8·annex-i/chapter-ii·annex-i/chapter-iii·annex-ix/chapter-ii·annex-vi/part-c/6.2.2·annex-xiii/part-a/2.3.2·chapter-i/section-1/article-2·chapter-ii/article-7·chapter-iii/article-29/1·chapter-vi/article-57/1·chapter-vi/article-59/6·chapter-vi/article-71/3·chapter-vi/article-73/5;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-i/chapter-i/6·annex-i/chapter-i/8·annex-i/chapter-ii·annex-i/chapter-iii·annex-ii/1.1·annex-ii/6.1·annex-ix/chapter-ii·annex-vi/part-c/6.5.2·annex-xiii/1·annex-xiv/part-a/3·chapter-i/article-2·chapter-ii/article-7·chapter-iii/article-32/1;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-600-112;nist-ai-rmf5.2·6;nistir-81837 - performance evaluation 2 clauses:
eu-ivdrannex-ix/chapter-ii·chapter-i/section-1/article-2 - performance of a device 4 clauses:
eu-ivdrannex-i/chapter-i/6·chapter-i/section-1/article-2;eu-mdrannex-i/chapter-i/6·chapter-i/article-2 - performance study 7 clauses:
eu-ivdrannex-i/chapter-iii·annex-xiii/part-a/2.3.2·chapter-i/section-1/article-2·chapter-vi/article-57/1·chapter-vi/article-59/6·chapter-vi/article-71/3·chapter-vi/article-73/5 - performance study plan 3 clauses:
eu-ivdrannex-xiii/part-a/2.3.2·chapter-i/section-1/article-2·chapter-vi/article-73/5 - personal data 2 clauses:
eu-digital-omnibus-aiarticle-1/3;nist-ai-600-112 - placing on the market 6 clauses:
eu-digital-omnibus-aiarticle-1/3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3·chapter-ii/article-10/7;eu-mdrchapter-i/article-2 - positive predictive value 2 clauses:
eu-ivdrannex-i/chapter-ii·chapter-i/section-1/article-2 - post-market surveillance 4 clauses:
eu-ivdrannex-ix/chapter-ii·chapter-i/section-1/article-2;eu-mdrannex-ix/chapter-ii·chapter-i/article-2 - predictive value 3 clauses:
eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii·chapter-i/section-1/article-2 - procedure pack 1 clause:
eu-mdrchapter-i/article-2 - Product Lifecycle 1 clause:
fda-ai-guidance7 - product with digital elements 10 clauses:
eu-cyber-resilience-actannex-i/part-i·annex-i/part-ii·annex-ii·annex-vii·chapter-ii/article-13/16·chapter-ii/article-13/17·chapter-ii/article-13/18·chapter-ii/article-13/8·chapter-ii/article-14/5·chapter-ii/article-19/2 - professional user 3 clauses:
eu-machinery-regulationchapter-i/article-3·chapter-ii/article-18;eu-mdrchapter-i/article-2 - protective device 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - provider 10 clauses:
ema-annex11-concept-paper1;eu-ai-actannex-iv/1·chapter-viii/article-71/4;eu-digital-omnibus-aiarticle-1/3;eu-gmp-annex-11-draft17;eu-gmp-annex-2210;eu-nis2chapter-i/article-6;fda-device-cybersecurity-20266;nist-ai-600-112;nistir-81837 - public administration entity 1 clause:
eu-nis2chapter-i/article-6 - public electronic communications network 1 clause:
eu-nis2chapter-i/article-6 - putting into service 7 clauses:
eu-digital-omnibus-aiarticle-1/3;eu-ivdrchapter-i/section-1/article-2·chapter-ii/article-7;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrchapter-i/article-2·chapter-ii/article-7 - qualified trust service 1 clause:
eu-nis2chapter-i/article-6 - qualified trust service provider 1 clause:
eu-nis2chapter-i/article-6 - Quality 8 clauses:
ema-annex11-concept-paper1;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-1512;eu-gmp-annex-2210;fda-ai-guidance7;fda-device-cybersecurity-20266;nistir-81837 - Quality Risk Management 4 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-2210;fda-ai-guidance7 - Quality System 5 clauses:
ema-annex11-concept-paper1;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;fda-ai-guidance7;fda-device-cybersecurity-20266 - reasonably foreseeable misuse 4 clauses:
eu-cyber-resilience-actannex-ii;eu-digital-omnibus-aiarticle-1/3;eu-machinery-regulationannex-iii/part-b/5;fda-device-cybersecurity-20266 - recall 7 clauses:
eu-ivdrchapter-i/section-1/article-2·chapter-ii/article-10/13;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2·chapter-ii/article-10/14;fda-ai-guidance7;fda-device-cybersecurity-20266 - removable mechanical transmission device 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - representative 19 clauses:
eu-cyber-resilience-actchapter-iv/article-39/4;eu-cybersecurity-acttitle-iv/article-69/4;eu-gmp-annex-1annex-1/11;eu-gmp-annex-2210;eu-ivdrannex-i/chapter-iii·annex-xiii/part-a/2.3.2·chapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·annex-vii/3·chapter-i/article-3·chapter-v/article-30/4;eu-mdrannex-i/chapter-iii·annex-xiii/1·chapter-i/article-2;eu-nis2chapter-i/article-6;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-600-112;nistir-81837 - reprocessing 2 clauses:
eu-mdrannex-i/chapter-iii·chapter-i/article-2 - Requirements 5 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-machinery-regulationannex-iii/part-b/5;fda-device-cybersecurity-20266;nistir-81837 - research organisation 1 clause:
eu-nis2chapter-i/article-6 - Risk / risk 32 clauses:
ema-annex11-concept-paper1;eu-cyber-resilience-actannex-i/part-i;eu-digital-omnibus-aiarticle-1/3;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-1512;eu-gmp-annex-2210;eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii·annex-ii/1.1·annex-ix/chapter-ii·chapter-i/section-1/article-2·chapter-ii/article-7;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3·chapter-ii/article-18;eu-mdrannex-i/chapter-ii·annex-i/chapter-iii·annex-ii/1.1·annex-ix/chapter-ii·chapter-i/article-2·chapter-ii/article-7;eu-nis2chapter-i/article-6;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-600-112·3;nist-ai-rmf3.5·5·5.2·6;nistir-81837 - Risk Assessment 3 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266;nistir-81837 - Risk Management 9 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-2210;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-600-112·3;nist-ai-rmf6;nistir-81837 - ropes 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - safety component 1 clause:
eu-machinery-regulationchapter-i/article-3 - safety function 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - scientific validity of an analyte 1 clause:
eu-ivdrchapter-i/section-1/article-2 - security of network and information systems 1 clause:
eu-nis2chapter-i/article-6 - serious adverse event 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - serious incident 4 clauses:
eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2;eu-mdrannex-i/chapter-iii·chapter-i/article-2 - serious public health threat 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - significant cyber threat 1 clause:
eu-nis2chapter-i/article-6 - significant cybersecurity risk 1 clause:
fda-device-cybersecurity-20266 - single-use device 3 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrannex-i/chapter-iii·chapter-i/article-2 - SMC 1 clause:
eu-digital-omnibus-aiarticle-1/3 - SME 4 clauses:
eu-digital-omnibus-aiarticle-1/3;eu-gmp-annex-11-draft17;eu-gmp-annex-2210;nist-ai-rmf6 - social networking services platform 1 clause:
eu-nis2chapter-i/article-6 - software 32 clauses:
ema-annex11-concept-paper1;eu-ai-actannex-iv/1;eu-cyber-resilience-actannex-i/part-ii·annex-ii·annex-vii·chapter-ii/article-13/11;eu-gmp-annex-11-draft17·17.5;eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii·annex-ii/1.1·annex-ii/6.4·annex-vi/part-c/6.2.2·annex-vi/part-c/6.2.4·chapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3·chapter-ii/article-10/7;eu-mdrannex-i/chapter-ii·annex-i/chapter-iii·annex-ii/1.1·annex-ii/6.1·annex-vi/part-c/6.5.2·annex-vi/part-c/6.5.4·annex-xiv/part-a/3·chapter-i/article-2;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-600-112·3;nist-ai-rmf6;nistir-81837 - software bill of materials 3 clauses:
eu-cyber-resilience-actannex-i/part-ii·annex-ii·annex-vii - source code 2 clauses:
eu-machinery-regulationchapter-i/article-3;fda-device-cybersecurity-20266 - special categories of personal data 1 clause:
eu-digital-omnibus-aiarticle-1/3 - specimen receptacle 1 clause:
eu-ivdrchapter-i/section-1/article-2 - sponsor 9 clauses:
eu-ivdrannex-xiii/part-a/2.3.2·chapter-i/section-1/article-2·chapter-vi/article-71/3·chapter-vi/article-73/5;eu-mdrchapter-i/article-2·chapter-vi/article-75/3·chapter-vi/article-77/5;fda-ai-guidance7;fda-device-cybersecurity-20266 - Stakeholder 1 clause:
nist-ai-600-112 - standard 14 clauses:
eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-1512;eu-ivdrannex-vi/part-c/6.2.4·chapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrannex-vi/part-c/6.5.4·chapter-i/article-2;eu-nis2chapter-i/article-6;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-600-112;nist-ai-rmf6 - Static test 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - subject 22 clauses:
ema-annex11-concept-paper1;eu-digital-omnibus-aiarticle-1/3;eu-gmp-annex-1annex-1/11;eu-gmp-annex-11-draft17;eu-gmp-annex-1512;eu-gmp-annex-2210;eu-ivdrannex-i/chapter-ii·chapter-i/section-1/article-2·chapter-vi/article-59/6·chapter-vi/article-71/3;eu-machinery-regulationannex-iii/part-b/5·chapter-ii/article-18;eu-mdrchapter-i/article-2·chapter-vi/article-63/6·chapter-vi/article-75/3;eu-nis2chapter-i/article-6;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-600-112·3;nist-ai-rmf3.4·6 - substantial modification 4 clauses:
eu-ivdrchapter-vi/article-71/3;eu-machinery-regulationchapter-i/article-3·chapter-ii/article-18;eu-mdrchapter-vi/article-75/3 - Supervisor 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - Supervisory function 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - support period 5 clauses:
eu-cyber-resilience-actannex-ii·annex-vii·chapter-ii/article-13/18·chapter-ii/article-13/8·chapter-v/article-52/16 - System / system 40 clauses:
ema-annex11-concept-paper1;eu-ai-actannex-iv/1;eu-cyber-resilience-actannex-vii;eu-digital-omnibus-aiarticle-1/3;eu-gmp-annex-1annex-1/11;eu-gmp-annex-114.5;eu-gmp-annex-11-draft17·17.5;eu-gmp-annex-1512·3.1;eu-gmp-annex-2210;eu-ivdrannex-i/chapter-ii·annex-ii/1.1·annex-ix/chapter-ii·annex-vi/part-c/6.2.4·chapter-i/section-1/article-2·chapter-vi/article-59/6·chapter-vi/article-69/5·chapter-vi/article-73/5;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrannex-i/chapter-ii·annex-ii/1.1·annex-ix/chapter-ii·annex-vi/part-c/6.5.4·chapter-i/article-2·chapter-vi/article-63/6·chapter-vi/article-73/5·chapter-vi/article-77/5;eu-nis2chapter-i/article-6;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-600-112·3;nist-ai-rmf3.4·3.5·5·5.2·6;nistir-81837 - technical specification 1 clause:
eu-nis2chapter-i/article-6 - technical specifications 4 clauses:
eu-cyber-resilience-actannex-vii;eu-machinery-regulationannex-vii/4·chapter-i/article-3;eu-mdrannex-ii/1.1 - Test coefficient 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - testing data 2 clauses:
eu-digital-omnibus-aiarticle-1/3;eu-gmp-annex-1annex-1/11 - TLD name registry 1 clause:
eu-nis2chapter-i/article-6 - top-level domain name registry 1 clause:
eu-nis2chapter-i/article-6 - training data 5 clauses:
eu-gmp-annex-2210;fda-ai-guidance7;nist-ai-600-112·3;nist-ai-rmf3.4 - trust service 1 clause:
eu-nis2chapter-i/article-6 - trust service provider 1 clause:
eu-nis2chapter-i/article-6 - UDI 14 clauses:
eu-ivdrannex-i/chapter-iii·annex-ii/1.1·annex-vi/part-c/5.10·annex-vi/part-c/6.2.2·annex-vi/part-c/6.2.4·chapter-i/section-1/article-2;eu-mdrannex-i/chapter-iii·annex-ii/1.1·annex-vi/part-c/5.10·annex-vi/part-c/6.5.2·annex-vi/part-c/6.5.4·chapter-i/article-2·chapter-iii/article-28/4;fda-device-cybersecurity-20266 - Union harmonisation legislation 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 - Unique Device Identifier 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - vulnerability 9 clauses:
eu-cyber-resilience-actannex-i/part-ii·annex-ii·annex-vii·chapter-ii/article-13/8;eu-gmp-annex-11-draft17;eu-nis2chapter-i/article-6;fda-device-cybersecurity-20266;nist-ai-600-112;nistir-81837 - webbing 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - withdrawal 3 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2 - Working coefficient 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - written 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
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 |
|---|---|---|---|---|
17bed942038f unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
6d68d146b07c (current) | 0 | 7 | 0 |
| 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 | 30 | 14 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
58dbc3006d27 | 0 | 2 | 3 | |
9d16077b1d3b (current) | 0 | 2 | 3 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
9206a43954eb (current) | 0 | 22 | 2 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
1fe6027daa2c (current) | 0 | 9 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
92eb86f25281 (current) | 0 | 1 | 2 |
| 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 | 4 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
797a882ba0ea | 0 | 0 | 0 | |
53742d793b68 (current) | 0 | 2 | 0 | |
ac0054416554 | 0 | 0 | 0 | |
749c40132375 | 0 | 0 | 0 | |
f110d5d47c11 | 0 | 0 | 0 | |
bf56cba791d8 | 0 | 0 | 0 | |
3db9896305a6 | 0 | 0 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
0e885238d69a unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
7a8b8a6e95d5 (current) | 0 | 29 | 9 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
50a728365a3b unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
db59da980bed (current) | 0 | 2 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
797a882ba0ea | 0 | 0 | 0 | |
07dc6a9975d1 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
f8b98469078e (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
85a680107f4d unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
8f04120f403b (current) | 0 | 14 | 5 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
903e40aaebe6 (current) | 1 | 44 | 4 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
1fc20ae2ffd8 | 0 | 14 | 1 | |
82fb682a6c54 (current) | 0 | 14 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
14d00b77d5c8 | 1 | 51 | 4 | |
fab624c8e1dc (current) | 1 | 51 | 4 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
023dc18395dc (current) | 0 | 3 | 4 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
61d4603ff66e | 0 | 0 | 0 | |
088a7a37c55d | 0 | 0 | 0 | |
630bd27c7b42 | 0 | 0 | 4 | |
5c61f4c6351d (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
b52b706d5cca (current) | 0 | 0 | 0 | |
d34d8c706d88 | 0 | 15 | 13 |
| 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 | 15 | 13 |
| 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 | 8 | 2 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
5e9388123e17 (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 | 2 | 23 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
8afebcc0941a | 0 | 0 | 0 | |
c240f2675bd3 | 0 | 0 | 0 | |
4c10dc03228b (current) | 0 | 4 | 7 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
770a1e5f76c1 | 0 | 1 | 0 | |
ed70ef992f63 (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
92b7bfe588c4 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
fe392d207918 (current) | 0 | 0 | 14 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
f0554d5c3fab | 0 | 0 | 1 | |
6a4d277ca4f8 | 0 | 0 | 1 | |
95bf4a66f2d4 | 0 | 0 | 1 | |
98ed07f87cdd | 0 | 0 | 1 | |
15f94377c4fc | 0 | 0 | 1 | |
9269c75204ff | 0 | 0 | 1 | |
4d93ac00b602 | 0 | 0 | 1 | |
825750c5633d | 0 | 0 | 1 | |
39db0dd17f53 | 0 | 0 | 1 | |
244eba4196bb | 0 | 0 | 1 | |
605180a389c7 | 0 | 0 | 1 | |
ed1c9acbb776 | 0 | 0 | 1 | |
bbbd805d0905 (current) | 0 | 0 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
393b48f902b8 | 0 | 0 | 1 | |
5997ebbb6661 | 0 | 0 | 1 | |
9d7b6d9aa4e1 | 0 | 0 | 1 | |
18e04a0c925a | 0 | 0 | 1 | |
1e7f13684129 | 0 | 0 | 1 | |
f24b92ecdf42 | 0 | 0 | 1 | |
b670ac9656b7 | 0 | 0 | 1 | |
bc527e48bcd8 | 0 | 0 | 1 | |
4edb9480421c | 0 | 0 | 1 | |
cd3e1c0c936b | 0 | 0 | 1 | |
75605421c92f (current) | 0 | 0 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
8b8ac787c687 | 0 | 0 | 1 | |
fa65ecef3a81 | 0 | 0 | 1 | |
8ee8e1aad0a5 | 0 | 0 | 1 | |
f3605b69e136 | 0 | 0 | 1 | |
baa155d883e3 | 0 | 0 | 1 | |
ac6e97a3c75d | 0 | 0 | 1 | |
bb66b9cbb2c4 | 0 | 0 | 1 | |
0e1bbcb2d14d | 0 | 0 | 1 | |
0eb9eade1868 | 0 | 0 | 1 | |
94a77d5625e8 | 0 | 0 | 1 | |
ca64082d7f23 (current) | 0 | 0 | 0 |
Feed
/atom/term/user.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 IVDR | true | open | true | true |
| EU MDR | true | open | true | true |
| EU Cybersecurity Act | true | open | true | true |
| EU Machinery Regulation | true | open | true | true |
| 21 CFR Part 11 | true | open | true | true |
| EU AI Act | true | open | true | true |
| EU GMP Annex 22 | true | open | true | true |
| FDA device cybersecurity | true | open | true | true |
| FDA device cybersecurity (2026) | true | open | true | true |
| EU GMP Annex 11 | true | open | true | true |
| EU Cyber Resilience Act | true | open | true | true |
| EU NIS2 Directive | true | open | true | true |
| 21 CFR Part 820 (QMSR) | true | open | true | true |
| ICH Q9(R1) | true | open | true | true |
| FDA electronic systems (clinical) | true | open | true | true |
| Regulation (EU) 2026/1744 | true | open | true | true |
| ICH Q13 | true | open | true | true |
| EU GMP Chapter 4 | true | open | true | true |
One row for each entry whose own characters this page prints: a text defining a form printed here, or a definition quoted. A row named or linked without its characters printed, or whose title only or sentence clauses only are given, has no row.
Each value is read by the same function the API reads, and each field is defined in the published schema. None of the four is a grant.
Last updated: