software
shared term, no equivalence asserted
The rows below print this term in 6 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 1 definition in this view is quoted and 0 are withheld with the reason. No reading here says that two of them agree or differ.
Australia
- Defined in
- no current text of a row of this jurisdiction defines it
- Rows printing it in a normative sentence
- 0
- Rows printing it in a title
- 1
- Rows printing it in body
- 0
EU
- Defined in
- EU Cyber Resilience Act
chapter-i/article-3(4): the part of an electronic information system which consists of computer code; - Rows printing it in a normative sentence
- 11
- Rows printing it in a title
- 0
- Rows printing it in body
- 10
International
- 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
- 3
- Rows printing it in body
- 5
Switzerland
- Defined in
- no current text of a row of this jurisdiction defines it
- Rows printing it in a normative sentence
- 0
- Rows printing it in a title
- 1
- Rows printing it in body
- 0
UK
- Defined in
- no current text of a row of this jurisdiction defines it
- Rows printing it in a normative sentence
- 0
- Rows printing it in a title
- 1
- 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
- 8
- Rows printing it in a title
- 0
- Rows printing it in body
- 10
This form is printed by the
tracked documents, each as a document defines it. The index’s key is
software (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 Cyber Resilience Act
EUtext first observedchapter-i/article-3(4)software: the part of an electronic information system which consists of computer code;
In normative sentences
229 sentences in 21 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
EU2 sentences; text first observed1: 2 sentences (should, may) - EMA CT computerised systems
EU15 sentences; text first observedid repeats in this text: 1 sentence (should) · follows a withheld heading: 3 sentences (may, should) · id repeats in this text: 11 sentences (should, may) - EU AI Act
EU7 sentences; text first observedno clause anchor before this sentence: 6 sentences (should, may) ·chapter-iii/section-2/article-13/3: 1 sentence (shall, may) - EU Cyber Resilience Act
EU57 sentences; text first observedno clause anchor before this sentence: 28 sentences (should, may) ·chapter-i/article-3: 1 sentence (may) ·chapter-i/article-4/3: 1 sentence (shall) ·chapter-i/article-9/1: 1 sentence (shall) ·chapter-ii/article-13/5: 1 sentence (shall) ·chapter-ii/article-13/6: 1 sentence (shall) ·chapter-ii/article-13/10: 1 sentence (may) ·chapter-ii/article-13/11: 2 sentences (may, shall) ·chapter-ii/article-13/24: 1 sentence (may) ·chapter-ii/article-13/25: 3 sentences (may) ·chapter-ii/article-24/1: 2 sentences (shall) ·chapter-ii/article-24/2: 2 sentences (shall) ·chapter-ii/article-24/3: 2 sentences (shall) ·chapter-ii/article-26/2: 1 sentence (shall) ·chapter-iii/article-30/1: 1 sentence (shall) ·chapter-iii/article-32/5: 1 sentence (shall) ·chapter-v/article-52/3: 3 sentences (shall) ·chapter-v/article-52/15: 1 sentence (shall) ·chapter-vii/article-64/10: 1 sentence (shall) ·annex-i/part-ii: 1 sentence (shall, may) ·annex-vii: 2 sentences (shall) - EU Cybersecurity Act
EU4 sentences; text first observedno clause anchor before this sentence: 3 sentences (should) ·title-iii/article-51: 1 sentence (shall) - EU GMP Annex 11
EU2 sentences; text first observed3.4: 1 sentence (should) ·4.3: 1 sentence (should) - EU GMP Annex 11 (draft)
EU5 sentences; text first observed17: 4 sentences (should, may) ·17.5: 1 sentence (may) - EU IVDR
EU24 sentences; text first observedno clause anchor before this sentence: 2 sentences (should) ·annex-i/chapter-ii: 4 sentences (shall) ·annex-i/chapter-iii: 1 sentence (shall, may) ·annex-ii/1.1: 1 sentence (may) ·annex-ii/3.1: 1 sentence (shall) ·annex-ii/6.4: 1 sentence (shall) ·annex-vi/part-c/3.5: 1 sentence (shall) ·annex-vi/part-c/6.2.1: 3 sentences (shall) ·annex-vi/part-c/6.2.2: 1 sentence (shall) ·annex-vi/part-c/6.2.3: 2 sentences (shall) ·annex-vi/part-c/6.2.4: 3 sentences (shall) ·annex-vii/3.2.2: 1 sentence (shall) ·annex-vii/3.2.5: 1 sentence (shall) ·annex-viii/1.4: 1 sentence (shall) ·annex-xiii/part-a/1.1: 1 sentence (shall) - EU Machinery Regulation
EU17 sentences; text first observedno clause anchor before this sentence: 6 sentences (should) ·chapter-i/article-3: 1 sentence (may) ·chapter-ii/article-10/7: 1 sentence (shall) ·chapter-ii/article-11/7: 1 sentence (shall) ·annex-iii/part-b/5: 6 sentences (shall) ·annex-iv/part-a: 1 sentence (shall) ·annex-iv/part-b: 1 sentence (shall) - EU MDR
EU24 sentences; text first observedno clause anchor before this sentence: 2 sentences (should) ·chapter-i/article-2: 2 sentences (may, shall) ·annex-i/chapter-ii: 4 sentences (shall) ·annex-i/chapter-iii: 2 sentences (shall, should) ·annex-vi/part-c/3.5: 1 sentence (shall) ·annex-vi/part-c/6.5.1: 3 sentences (shall) ·annex-vi/part-c/6.5.2: 1 sentence (shall) ·annex-vi/part-c/6.5.3: 2 sentences (shall) ·annex-vi/part-c/6.5.4: 3 sentences (shall) ·annex-vii/3.2.2: 1 sentence (shall) ·annex-vii/3.2.5: 1 sentence (shall) ·annex-viii/chapter-ii: 1 sentence (shall) ·annex-xiv/part-a/3: 1 sentence (shall) - EU NIS2 Directive
EU4 sentences; text first observedno clause anchor before this sentence: 4 sentences (should, may) - FDA AI guidance
US1 sentence; text first observed7: 1 sentence (should) - FDA CSA
US1 sentence; text first observedno numbering read: 1 sentence (may) - FDA device cybersecurity (2026)
US56 sentences; text first observed6: 56 sentences (must, may, shall, should) - FDA electronic systems (clinical)
US3 sentences; text first observedno clause anchor before this sentence: 3 sentences (should) - FDA GMLP guiding principles
US1 sentence; text first observedno numbering read: 1 sentence (may) - FDA postmarket cybersecurity
US1 sentence; text first observedno numbering read: 1 sentence (may) - ICH Q14
International1 sentence; text first observed13.2: 1 sentence (should) - NIST AI RMF
International2 sentences; text first observed5.3: 1 sentence (should) ·6: 1 sentence (may) - NISTIR 8183
US1 sentence; text first observed7: 1 sentence (may) - 21 CFR Part 11
US1 sentence; text first observedno numbering read: 1 sentence (may, shall)
In titles
6 tracked rows whose titles print one of the forms in the heading, read from the title this record holds, by the same exact rule.
- IEC 62304 — Medical device software life cycle processes
International - IEC 81001-5-1 (the title is over 14 words and is not quoted; the row and the count of forms it prints are given)
International - ISO 81001-1 (the title is over 14 words and is not quoted; the row and the count of forms it prints are given)
International - MHRA publications on AI and software as a medical device
UK - Swissmedic publications on medical device software
Switzerland - TGA regulation of software as a medical device
Australia
In body
206 occurrences in 26 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
EU3 occurrences; text first observed3 where the heading before it is withheld - EMA data quality framework
EU7 occurrences; text first observed10: 7 - EU AI Act
EU7 occurrences; text first observedannex-iv/1: 3 ·annex-iv/2: 1 ·annex-xi/section-2/3: 1 ·annex-xii/1: 2 - EU Cyber Resilience Act
EU27 occurrences; text first observedannex-ii: 2 ·annex-iii/1: 1 ·annex-iii/4: 1 ·annex-iii/9: 1 ·chapter-ii/article-24: 1 ·chapter-ii/article-25: 3 · 18 where no heading is read before it - EU Cybersecurity Act
EU1 occurrence; text first observed1 where no heading is read before it - EU GMP Annex 11
EU4 occurrences; text first observed17: 3 · 1 where no heading is read before it - EU GMP Annex 11 (draft)
EU8 occurrences; text first observed17: 3 ·17.5: 5 - EU IVDR
EU6 occurrences; text first observedannex-i/chapter-ii: 1 ·annex-vi/part-c/1: 1 ·annex-vi/part-c/6.2: 1 ·chapter-i/section-1/article-2: 3 - EU MDR
EU9 occurrences; text first observedannex-i/chapter-ii: 1 ·annex-ii/1.1: 1 ·annex-ii/6.1: 3 ·annex-vi/part-c/1: 1 ·annex-vi/part-c/6.5.3: 1 ·annex-viii/chapter-iii: 1 ·annex-xv/chapter-ii/2.3: 1 - EU NIS2 Directive
EU3 occurrences; text first observed3 where no heading is read before it - FDA AI device list
US2 occurrences; text first observed2 where no numbering read in this text - FDA CDRH AI/ML
US1 occurrence; text first observed1 where no numbering read in this text - FDA clinical decision support
US7 occurrences; text first observed7 where no numbering read in this text - FDA CSA
US1 occurrence; text first observed1 where no numbering read in this text - FDA device cybersecurity (2026)
US58 occurrences; text first observed6: 58 - FDA electronic systems (clinical)
US5 occurrences; text first observed5 where no heading is read before it - FDA/EMA AI principles
International1 occurrence; text first observed1 where no numbering read in this text - FDA software validation
US2 occurrences; text first observed2 where no numbering read in this text - ICH Q13
International1 occurrence; text first observed1 where the heading before it is withheld - ICH Q14
International3 occurrences; text first observed13.2: 2 · 1 where the heading before it is withheld - ICH Q9(R1)
International1 occurrence; text first observed25: 1 - MHRA AI
UK4 occurrences; text first observed4 where no numbering read in this text - NIST AI 600-1
US10 occurrences; text first observed12: 9 ·3: 1 - NIST AI RMF
International7 occurrences; text first observed1.2.1: 1 ·1.2.4: 1 ·6: 4 · 1 where no heading is read before it - NISTIR 8183
US25 occurrences; text first observed7: 25 - 21 CFR Part 820 (QMSR)
US3 occurrences; text first observed3 where no numbering read in this text
Co-occurrence
200 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. 128 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 2 clauses:
eu-mdrannex-viii/chapter-iii·chapter-i/article-2 - actively exploited vulnerability 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - adverse event 3 clauses:
ema-data-quality-framework10;eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - Agency 4 clauses:
ema-data-quality-framework10;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 system 9 clauses:
eu-ai-actannex-iv/1·annex-iv/2·chapter-iii/section-2/article-13/3;nist-ai-600-112·3;nist-ai-rmf1.2.1·1.2.4·5.3·6 - allow-list 1 clause:
fda-device-cybersecurity-20266 - analytical performance 3 clauses:
eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii·chapter-i/section-1/article-2 - Application 8 clauses:
eu-gmp-annex-11-draft17.5;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-vi/part-c/6.5.4·annex-viii/chapter-ii;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-rmf6;nistir-81837 - authorised representative 8 clauses:
eu-ai-actchapter-iii/section-2/article-13/3;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrannex-i/chapter-iii·chapter-i/article-2 - 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 - calibrator 1 clause:
eu-ivdrchapter-i/section-1/article-2 - Carrier 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - CE marking 5 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-iii/article-30/1;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 4 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;ich-q9r125;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 4 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrannex-ii/6.1·annex-xiv/part-a/3·chapter-i/article-2 - clinical evaluation 6 clauses:
eu-mdrannex-ii/6.1·annex-vii/3.2.2·annex-vii/3.2.5·annex-xiv/part-a/3·annex-xv/chapter-ii/2.3·chapter-i/article-2 - clinical evidence 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - clinical investigation 3 clauses:
eu-mdrannex-i/chapter-iii·chapter-i/article-2;fda-ai-guidance7 - clinical investigation plan 1 clause:
eu-mdrchapter-i/article-2 - clinical performance 7 clauses:
eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii·annex-xiii/part-a/1.1·chapter-i/section-1/article-2;eu-mdrannex-i/chapter-iii·annex-xiv/part-a/3·chapter-i/article-2 - companion diagnostic 3 clauses:
eu-ivdrannex-i/chapter-iii·annex-ii/1.1·chapter-i/section-1/article-2 - Component / component 12 clauses:
eu-ai-actannex-iv/1;eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-13/6;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 10 clauses:
eu-ai-actchapter-iii/section-2/article-13/3;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrannex-vii/3.2.5·chapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrannex-i/chapter-ii·annex-vii/3.2.5·chapter-i/article-2;nist-ai-600-112 - conformity assessment body 4 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2 - consumer 4 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-i/article-9/1;nist-ai-600-112;nistir-81837 - control material 1 clause:
eu-ivdrchapter-i/section-1/article-2 - corrective action 5 clauses:
eu-cyber-resilience-actchapter-v/article-52/3;eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2;fda-device-cybersecurity-20266;ich-q9r125 - critical infrastructure 2 clauses:
nist-ai-600-112;nistir-81837 - CSIRT designated as coordinator 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - custom-made device 2 clauses:
eu-mdrannex-i/chapter-iii·chapter-i/article-2 - cyber threat 2 clauses:
eu-cyber-resilience-actchapter-i/article-3;fda-device-cybersecurity-20266 - cybersecurity 17 clauses:
eu-ai-actannex-iv/2·chapter-iii/section-2/article-13/3;eu-cyber-resilience-actannex-ii·annex-vii·chapter-i/article-3·chapter-ii/article-13/10·chapter-ii/article-13/5·chapter-ii/article-24/1·chapter-ii/article-24/2·chapter-ii/article-25·chapter-iii/article-32/5;eu-cybersecurity-acttitle-iii/article-51;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-600-112;nist-ai-rmf6;nistir-81837 - cybersecurity risk 6 clauses:
eu-cyber-resilience-actchapter-i/article-3;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 - deployer 1 clause:
eu-ai-actannex-iv/1 - derivative 2 clauses:
eu-mdrannex-i/chapter-iii·chapter-i/article-2 - device deficiency 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - device for near-patient testing 1 clause:
eu-ivdrchapter-i/section-1/article-2 - device for performance study 2 clauses:
eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2 - device for self-testing 1 clause:
eu-ivdrchapter-i/section-1/article-2 - 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 - distributor 4 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2 - Driver 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - Dynamic test 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - economic operator 4 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2 - electronic information system 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - Electronic record 1 clause:
eu-gmp-annex-11-draft17.5 - end-point 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - end-to-end 1 clause:
fda-device-cybersecurity-20266 - entity 4 clauses:
ema-data-quality-framework10;eu-cyber-resilience-actchapter-ii/article-13/6;fda-ai-guidance7;fda-device-cybersecurity-20266 - essential health and safety requirements 4 clauses:
eu-machinery-regulationannex-iii/part-b/5·annex-iv/part-a·annex-iv/part-b·chapter-i/article-3 - ethics committee 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - European cybersecurity certification scheme 1 clause:
eu-cybersecurity-acttitle-iii/article-51 - European standard 3 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - exploitable vulnerability 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - falsified device 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - 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 - free and open-source software 7 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-13/25·chapter-ii/article-13/5·chapter-ii/article-24/2·chapter-ii/article-25·chapter-ii/article-26/2·chapter-iii/article-32/5 - fully refurbishing 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - general-purpose AI model 1 clause:
eu-ai-actannex-xii/1 - 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 28 clauses:
ema-annex11-concept-paper1;eu-ai-actannex-iv/1·annex-xii/1·chapter-iii/section-2/article-13/3;eu-cyber-resilience-actannex-iii/1·annex-vii·chapter-i/article-3·chapter-ii/article-13/10·chapter-ii/article-13/6;eu-cybersecurity-acttitle-iii/article-51;eu-gmp-annex-1117·4.3;eu-gmp-annex-11-draft17·17.5;eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii·annex-ii/3.1·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;ich-q9r125;nist-ai-600-112;nist-ai-rmf1.2.1·1.2.4;nistir-81837 - Harm 2 clauses:
fda-device-cybersecurity-20266;nist-ai-600-112 - harmonised standard 5 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 - Hazard / hazard 4 clauses:
eu-ivdrannex-i/chapter-iii;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;ich-q9r125 - health institution 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - ICT process 1 clause:
eu-cybersecurity-acttitle-iii/article-51 - ICT product 1 clause:
eu-cybersecurity-acttitle-iii/article-51 - ICT service 1 clause:
eu-cybersecurity-acttitle-iii/article-51 - identity management 1 clause:
fda-device-cybersecurity-20266 - implantable device 1 clause:
eu-mdrchapter-i/article-2 - importer 4 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2 - in vitro diagnostic medical device 2 clauses:
eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2 - incident 10 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-cybersecurity-acttitle-iii/article-51;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;fda-device-cybersecurity-20266;nist-ai-600-112;nistir-81837 - incident handling 1 clause:
nistir-81837 - indirect connection 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - informed consent 4 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2;fda-device-cybersecurity-20266;nist-ai-600-112 - input data 4 clauses:
eu-ai-actchapter-iii/section-2/article-13/3;ich-q1413.2;nist-ai-600-112·3 - instructions for use 13 clauses:
eu-ai-actannex-iv/1·chapter-iii/section-2/article-13/3;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii·chapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·annex-iv/part-a·chapter-i/article-3·chapter-ii/article-10/7;eu-mdrannex-i/chapter-ii·annex-i/chapter-iii·chapter-i/article-2 - intended purpose 23 clauses:
eu-ai-actannex-iv/1·chapter-iii/section-2/article-13/3;eu-cyber-resilience-actannex-ii·annex-vii·chapter-i/article-3;eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii·annex-ii/1.1·annex-vi/part-c/1·annex-xiii/part-a/1.1·chapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrannex-i/chapter-ii·annex-i/chapter-iii·annex-ii/1.1·annex-ii/6.1·annex-vi/part-c/1·annex-viii/chapter-ii·annex-viii/chapter-iii·annex-xiv/part-a/3·chapter-i/article-2;ich-q1413.2;nist-ai-600-112 - intended use 13 clauses:
ema-data-quality-framework10;eu-gmp-annex-11-draft17;eu-ivdrannex-i/chapter-ii·annex-vi/part-c/6.2.2·annex-xiii/part-a/1.1;eu-machinery-regulationannex-iii/part-b/5·annex-iv/part-a;eu-mdrannex-i/chapter-ii·annex-vi/part-c/6.5.2;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r125;nist-ai-600-112 - interchangeable equipment 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - international standard 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - interventional clinical performance study 1 clause:
eu-ivdrchapter-i/section-1/article-2 - invasive device 1 clause:
eu-mdrchapter-i/article-2 - investigational device 1 clause:
eu-mdrchapter-i/article-2 - investigator 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - kit 2 clauses:
eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2 - label 10 clauses:
eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii·annex-vi/part-c/3.5·chapter-i/section-1/article-2;eu-mdrannex-i/chapter-ii·annex-i/chapter-iii·annex-vi/part-c/3.5·chapter-i/article-2;ich-q9r125;nist-ai-600-112 - lay person 3 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrannex-i/chapter-ii·chapter-i/article-2 - lifetime 10 clauses:
eu-ai-actchapter-iii/section-2/article-13/3;eu-cyber-resilience-actannex-ii;eu-ivdrannex-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-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 - logical connection 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - machinery 6 clauses:
eu-machinery-regulationannex-iii/part-b/5·annex-iv/part-a·annex-iv/part-b·chapter-i/article-3·chapter-ii/article-10/7·chapter-ii/article-11/7 - Machinery or related products for plant protection products application 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - Machinery or related products presenting risks due to their mobility 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - making available on the market 6 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-i/article-4/3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrannex-i/chapter-iii·chapter-i/article-2 - manufacturer 28 clauses:
eu-cyber-resilience-actannex-i/part-ii·annex-ii·annex-vii·chapter-i/article-3·chapter-ii/article-13/10;eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii·annex-ii/1.1·annex-vi/part-c/1·annex-vi/part-c/6.2.3·chapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·annex-iv/part-a·annex-iv/part-b·chapter-i/article-3·chapter-ii/article-10/7·chapter-ii/article-11/7;eu-mdrannex-i/chapter-ii·annex-i/chapter-iii·annex-ii/1.1·annex-ii/6.1·annex-vi/part-c/1·annex-vi/part-c/6.5.3·annex-viii/chapter-ii·chapter-i/article-2;fda-ai-guidance7;fda-device-cybersecurity-20266;nistir-81837 - market surveillance 9 clauses:
eu-cyber-resilience-actannex-vii·chapter-i/article-3·chapter-ii/article-13/25·chapter-ii/article-24/2·chapter-v/article-52/15·chapter-v/article-52/3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2 - market surveillance authority 5 clauses:
eu-cyber-resilience-actannex-vii·chapter-i/article-3·chapter-ii/article-24/2·chapter-v/article-52/3;eu-machinery-regulationchapter-i/article-3 - medical device 7 clauses:
eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2;eu-mdrannex-i/chapter-iii·annex-viii/chapter-ii·chapter-i/article-2;fda-ai-guidance7;fda-device-cybersecurity-20266 - Metadata 2 clauses:
ema-data-quality-framework10;nist-ai-600-112 - nanomaterial 2 clauses:
eu-mdrannex-viii/chapter-iii·chapter-i/article-2 - national accreditation body 1 clause:
eu-machinery-regulationchapter-i/article-3 - near miss 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - negative predictive value 3 clauses:
eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii·chapter-i/section-1/article-2 - non-viable 3 clauses:
eu-mdrannex-i/chapter-ii·annex-viii/chapter-iii·chapter-i/article-2 - notified body 6 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-ivdrannex-vii/3.2.2·chapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrannex-vii/3.2.2·chapter-i/article-2 - notifying authority 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - open-source software steward 3 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-24/1·chapter-v/article-52/3 - operator 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 - particle 3 clauses:
eu-mdrchapter-i/article-2;ich-q1413.2;ich-q9r125 - partly completed machinery 5 clauses:
eu-machinery-regulationannex-iii/part-b/5·annex-iv/part-a·annex-iv/part-b·chapter-i/article-3·chapter-ii/article-11/7 - performance 31 clauses:
ema-data-quality-framework10;eu-ai-actannex-iv/2·chapter-iii/section-2/article-13/3;eu-gmp-annex-11-draft17·17.5;eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii·annex-vi/part-c/6.2.2·annex-vii/3.2.2·annex-vii/3.2.5·annex-xiii/part-a/1.1·chapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5;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-vii/3.2.5·annex-viii/chapter-iii·annex-xiv/part-a/3·annex-xv/chapter-ii/2.3·chapter-i/article-2;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q1413.2;ich-q9r125;nist-ai-600-112;nist-ai-rmf5.3·6;nistir-81837 - performance evaluation 4 clauses:
eu-ivdrannex-vii/3.2.2·annex-vii/3.2.5·annex-xiii/part-a/1.1·chapter-i/section-1/article-2 - performance of a device 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2 - performance study 2 clauses:
eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2 - performance study plan 1 clause:
eu-ivdrchapter-i/section-1/article-2 - personal data 2 clauses:
eu-cyber-resilience-actchapter-i/article-3;nist-ai-600-112 - physical connection 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - placing on the market 8 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-iii/article-32/5;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3·chapter-ii/article-10/7·chapter-ii/article-11/7;eu-mdrchapter-i/article-2 - positive predictive value 2 clauses:
eu-ivdrannex-i/chapter-ii·chapter-i/section-1/article-2 - post-market surveillance 2 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-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 2 clauses:
fda-ai-guidance7;ich-q1413.2 - product with digital elements 9 clauses:
eu-cyber-resilience-actannex-i/part-ii·annex-ii·annex-vii·chapter-i/article-3·chapter-ii/article-13/5·chapter-ii/article-13/6·chapter-ii/article-24/1·chapter-ii/article-24/2·chapter-iii/article-30/1 - professional user 2 clauses:
eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2 - protective device 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - provider 9 clauses:
ema-annex11-concept-paper1;ema-data-quality-framework10;eu-ai-actannex-iv/1·annex-iv/2·chapter-iii/section-2/article-13/3;eu-gmp-annex-11-draft17;fda-device-cybersecurity-20266;nist-ai-600-112;nistir-81837 - putting into service 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 - Quality 9 clauses:
ema-annex11-concept-paper1;ema-data-quality-framework10;eu-gmp-annex-113.4;eu-gmp-annex-11-draft17;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q1413.2;ich-q9r125;nistir-81837 - Quality Risk Management 3 clauses:
eu-gmp-annex-11-draft17;fda-ai-guidance7;ich-q1413.2 - Quality System 6 clauses:
ema-annex11-concept-paper1;ema-data-quality-framework10;eu-gmp-annex-11-draft17;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q1413.2 - reasonably foreseeable misuse 5 clauses:
eu-ai-actchapter-iii/section-2/article-13/3;eu-cyber-resilience-actannex-ii·chapter-i/article-3;eu-machinery-regulationannex-iii/part-b/5;fda-device-cybersecurity-20266 - reasonably foreseeable use 1 clause:
eu-cyber-resilience-actchapter-i/article-3 - recall 7 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q9r125 - remote data processing 2 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-26/2 - removable mechanical transmission device 2 clauses:
eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3 - representative 14 clauses:
ema-data-quality-framework10;eu-ai-actchapter-iii/section-2/article-13/3;eu-cyber-resilience-actchapter-i/article-3;eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrannex-i/chapter-iii·chapter-i/article-2;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q1413.2;nist-ai-600-112;nistir-81837 - reprocessing 3 clauses:
eu-mdrannex-i/chapter-iii·chapter-i/article-2;ich-q9r125 - Requirements 5 clauses:
ema-data-quality-framework10;eu-gmp-annex-11-draft17;eu-machinery-regulationannex-iii/part-b/5;fda-device-cybersecurity-20266;nistir-81837 - Risk / risk 30 clauses:
ema-annex11-concept-paper1;eu-ai-actchapter-iii/section-2/article-13/3;eu-cyber-resilience-actchapter-i/article-3;eu-gmp-annex-11-draft17;eu-ivdrannex-i/chapter-ii·annex-i/chapter-iii·annex-ii/1.1·annex-vii/3.2.5·annex-xiii/part-a/1.1·chapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·annex-iv/part-a·annex-iv/part-b·chapter-i/article-3;eu-mdrannex-i/chapter-ii·annex-i/chapter-iii·annex-ii/1.1·annex-vii/3.2.5·chapter-i/article-2;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q1413.2;ich-q9r125;nist-ai-600-112·3;nist-ai-rmf1.2.1·1.2.4·5.3·6;nistir-81837 - Risk Assessment 3 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266;nistir-81837 - Risk Management 8 clauses:
eu-gmp-annex-11-draft17;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q1413.2;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 - 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 cybersecurity risk 2 clauses:
eu-cyber-resilience-actchapter-i/article-3;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 - SME 2 clauses:
eu-gmp-annex-11-draft17;nist-ai-rmf6 - software bill of materials 5 clauses:
eu-cyber-resilience-actannex-i/part-ii·annex-ii·annex-vii·chapter-i/article-3·chapter-ii/article-13/24 - source code 5 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-machinery-regulationannex-iv/part-a·annex-iv/part-b·chapter-i/article-3;fda-device-cybersecurity-20266 - specimen receptacle 1 clause:
eu-ivdrchapter-i/section-1/article-2 - sponsor 4 clauses:
eu-ivdrchapter-i/section-1/article-2;eu-mdrchapter-i/article-2;fda-ai-guidance7;fda-device-cybersecurity-20266 - Stakeholder 1 clause:
nist-ai-600-112 - standard 16 clauses:
ema-data-quality-framework10;eu-cyber-resilience-actchapter-i/article-3;eu-gmp-annex-11-draft17;eu-ivdrannex-vi/part-c/1·annex-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/1·annex-vi/part-c/6.5.4·chapter-i/article-2;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q1413.2;nist-ai-600-112;nist-ai-rmf6 - Static test 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - subject 19 clauses:
ema-annex11-concept-paper1;ema-data-quality-framework10;eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-24/1·chapter-ii/article-26/2;eu-gmp-annex-11-draft17;eu-ivdrannex-i/chapter-ii·annex-vi/part-c/6.2.1·chapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-vi/part-c/6.5.1·chapter-i/article-2;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q1413.2;nist-ai-600-112·3;nist-ai-rmf5.3·6 - substantial modification 3 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-26/2;eu-machinery-regulationchapter-i/article-3 - Supervisor 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - Supervisory function 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - support period 3 clauses:
eu-cyber-resilience-actannex-ii·annex-vii·chapter-i/article-3 - System / system 40 clauses:
ema-annex11-concept-paper1;ema-data-quality-framework10;eu-ai-actannex-iv/1·annex-iv/2·annex-xi/section-2/3·chapter-iii/section-2/article-13/3;eu-cyber-resilience-actannex-vii·chapter-i/article-3;eu-gmp-annex-1117·3.4·4.3;eu-gmp-annex-11-draft17·17.5;eu-ivdrannex-i/chapter-ii·annex-ii/1.1·annex-ii/3.1·annex-vi/part-c/6.2.1·annex-vi/part-c/6.2.4·chapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·annex-iv/part-a·annex-iv/part-b·chapter-i/article-3;eu-mdrannex-i/chapter-ii·annex-ii/1.1·annex-vi/part-c/6.5.1·annex-vi/part-c/6.5.4·annex-viii/chapter-iii·chapter-i/article-2;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q1413.2;ich-q9r125;nist-ai-600-112·3;nist-ai-rmf1.2.1·1.2.4·5.3·6;nistir-81837 - technical specifications 5 clauses:
eu-cyber-resilience-actannex-vii;eu-machinery-regulationannex-iv/part-a·annex-iv/part-b·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-ai-actannex-iv/2·chapter-iii/section-2/article-13/3 - training data 4 clauses:
eu-ai-actannex-iv/2;fda-ai-guidance7;nist-ai-600-112·3 - UDI 19 clauses:
eu-ivdrannex-i/chapter-iii·annex-ii/1.1·annex-vi/part-c/1·annex-vi/part-c/3.5·annex-vi/part-c/6.2.1·annex-vi/part-c/6.2.2·annex-vi/part-c/6.2.3·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/1·annex-vi/part-c/3.5·annex-vi/part-c/6.5.1·annex-vi/part-c/6.5.2·annex-vi/part-c/6.5.3·annex-vi/part-c/6.5.4·chapter-i/article-2;fda-device-cybersecurity-20266 - Union harmonisation legislation 7 clauses:
eu-cyber-resilience-actchapter-i/article-3·chapter-ii/article-26/2;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·annex-iv/part-a·chapter-i/article-3;eu-mdrchapter-i/article-2 - Unique Device Identifier 4 clauses:
eu-ivdrannex-vi/part-c/1·chapter-i/section-1/article-2;eu-mdrannex-vi/part-c/1·chapter-i/article-2 - Unit Operation 1 clause:
ich-q1413.2 - user 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 - validation data 1 clause:
ich-q1413.2 - vulnerability 9 clauses:
eu-cyber-resilience-actannex-i/part-ii·annex-ii·annex-vii·chapter-i/article-3·chapter-ii/article-13/6;eu-gmp-annex-11-draft17;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 4 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-ivdrchapter-i/section-1/article-2;eu-machinery-regulationchapter-i/article-3;eu-mdrchapter-i/article-2 - Working coefficient 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - written 10 clauses:
eu-cyber-resilience-actchapter-i/article-3;eu-gmp-annex-11-draft17;eu-ivdrannex-i/chapter-iii·chapter-i/section-1/article-2;eu-machinery-regulationannex-iii/part-b/5·chapter-i/article-3;eu-mdrannex-i/chapter-iii·chapter-i/article-2;nist-ai-600-112·3
History
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17bed942038f unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
6d68d146b07c (current) | 0 | 2 | 0 |
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90f72782b398 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
ebaf707c409d (current) | 0 | 15 | 3 |
| First observed | Text | Defined | In normative sentences | In body |
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e2ad4536a9bd unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
4d30b7bae7dd (current) | 0 | 0 | 7 |
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58dbc3006d27 | 0 | 7 | 7 | |
9d16077b1d3b (current) | 0 | 7 | 7 |
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9206a43954eb (current) | 1 | 57 | 27 |
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1fe6027daa2c (current) | 0 | 4 | 1 |
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797a882ba0ea | 0 | 0 | 0 | |
53742d793b68 (current) | 0 | 2 | 4 | |
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 | 5 | 8 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
903e40aaebe6 (current) | 0 | 24 | 6 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
1fc20ae2ffd8 | 0 | 17 | 0 | |
82fb682a6c54 (current) | 0 | 17 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
14d00b77d5c8 | 0 | 24 | 9 | |
fab624c8e1dc (current) | 0 | 24 | 9 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
023dc18395dc (current) | 0 | 4 | 3 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
61d4603ff66e | 0 | 0 | 0 | |
088a7a37c55d | 0 | 0 | 0 | |
630bd27c7b42 | 0 | 0 | 0 | |
5c61f4c6351d (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
7d8bfb6d13ca | 0 | 0 | 2 | |
a55b6f369034 | 0 | 0 | 2 | |
f0d90446093e (current) | 0 | 0 | 2 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
b8cd8587b556 (current) | 0 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
ad537c73610a (current) | 0 | 0 | 7 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
4843091843f0 (current) | 0 | 1 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
b52b706d5cca (current) | 0 | 0 | 0 | |
d34d8c706d88 | 0 | 56 | 58 |
| 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 | 56 | 58 |
| 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 | 3 | 5 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
b970b2dbbcaa unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
60a8c7bb10cf (current) | 0 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
ef0dfb4023b7 | 0 | 1 | 0 | |
2091aa6e2741 (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
d1889be52428 (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
c49d3a719515 (current) | 0 | 0 | 2 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
06273204f50b (current) | 0 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
5e9388123e17 (current) | 0 | 1 | 3 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
57c484f5daed (current) | 0 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
110d6c8e7c56 | 0 | 0 | 4 | |
d4b6bb0450a8 | 0 | 0 | 4 | |
0d4b2abb3a4f | 0 | 0 | 4 | |
8fc70fdfe3a5 | 0 | 0 | 4 | |
95ff73c7efa2 | 0 | 0 | 4 | |
21fde7c052b4 | 0 | 0 | 4 | |
d722379e4120 | 0 | 0 | 4 | |
f61cf3af5063 | 0 | 0 | 4 | |
adda145eadf9 (current) | 0 | 0 | 4 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
c0ab0e6263b3 | 0 | 0 | 1 | |
edcebd0e3a36 | 0 | 0 | 1 | |
9d19d28e1a57 | 0 | 0 | 1 | |
f2734caa33bb | 0 | 0 | 1 | |
8727e7836a62 | 0 | 0 | 1 | |
e6bfd1f64b25 | 0 | 0 | 0 | |
67d33a19b1a7 | 0 | 0 | 0 | |
05c0bdbc196e | 0 | 0 | 0 | |
8e07db344887 | 0 | 0 | 0 | |
84a3e0382b0e | 0 | 0 | 0 | |
6f9c326c480f | 0 | 0 | 0 | |
b413d56295e8 | 0 | 0 | 0 | |
e3d94d289c0b | 0 | 0 | 0 | |
d800e5bf4d9b (current) | 0 | 0 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
a5ad5867c187 unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
caa03fc84948 (current) | 0 | 0 | 10 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
8afebcc0941a | 0 | 0 | 0 | |
c240f2675bd3 | 0 | 0 | 0 | |
4c10dc03228b (current) | 0 | 2 | 7 |
| 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 | 25 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
f0554d5c3fab | 0 | 1 | 0 | |
6a4d277ca4f8 | 0 | 1 | 0 | |
95bf4a66f2d4 | 0 | 1 | 0 | |
98ed07f87cdd | 0 | 1 | 0 | |
15f94377c4fc | 0 | 1 | 0 | |
9269c75204ff | 0 | 1 | 0 | |
4d93ac00b602 | 0 | 1 | 0 | |
825750c5633d | 0 | 1 | 0 | |
39db0dd17f53 | 0 | 1 | 0 | |
244eba4196bb | 0 | 1 | 0 | |
605180a389c7 | 0 | 1 | 0 | |
ed1c9acbb776 | 0 | 1 | 0 | |
bbbd805d0905 (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
8b8ac787c687 | 0 | 0 | 3 | |
fa65ecef3a81 | 0 | 0 | 3 | |
8ee8e1aad0a5 | 0 | 0 | 3 | |
f3605b69e136 | 0 | 0 | 3 | |
baa155d883e3 | 0 | 0 | 3 | |
ac6e97a3c75d | 0 | 0 | 3 | |
bb66b9cbb2c4 | 0 | 0 | 3 | |
0e1bbcb2d14d | 0 | 0 | 3 | |
0eb9eade1868 | 0 | 0 | 3 | |
94a77d5625e8 | 0 | 0 | 3 | |
ca64082d7f23 (current) | 0 | 0 | 3 |
Feed
/atom/term/software.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 Cyber Resilience Act | true | open | true | true |
| EU MDR | true | open | true | true |
| EU IVDR | true | open | true | true |
| EU Cybersecurity Act | true | open | true | true |
| EU Machinery Regulation | true | open | true | true |
| 21 CFR Part 11 | true | open | true | true |
| EU AI Act | true | open | true | true |
| EU GMP Annex 22 | true | open | true | true |
| FDA device cybersecurity | true | open | true | true |
| FDA device cybersecurity (2026) | true | open | true | true |
| EU GMP Annex 11 | true | open | true | true |
| 21 CFR Part 820 (QMSR) | true | open | true | true |
| 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: