Application
shared term, no equivalence asserted
The rows below print this term in 3 jurisdictions, set side by side by each row’s own jurisdiction field, in code-unit order of that field. Each definition is kept apart under its own text, and quoted where the term and its text together sit under the quote cap: 0 of 1 definition in this view are quoted and 1 is withheld with the reason. No reading here says that two of them agree or differ.
EU
- Defined in
- EU GMP Annex 11no clause given: text withheld (end not delimited: a term in an entry form that these rules did not read as a definition lies before the next definition read)
- Rows printing it in a normative sentence
- 4
- Rows printing it in a title
- 0
- Rows printing it in body
- 7
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
- 1
- Rows printing it in body
- 3
US
- Defined in
- no current text of a row of this jurisdiction defines it
- Rows printing it in a normative sentence
- 2
- Rows printing it in a title
- 1
- Rows printing it in body
- 7
This form is printed by the
tracked documents, each as a document defines it. The index’s key is
application (the definitions derivation’s fold:
case set aside, spaces collapsed; each form is matched exactly as printed).
1 observed text defines it.
Counts below are over each row’s current text, the
81 of 126 current
texts the derivation read; a title is read for every one of the 132 tracked rows.
Defined
1 definition in 1 current text, as the definitions derivation’s rules read them, quoted where the term and its text together sit under the quote cap.
- EU GMP Annex 11
EUtext first observed- no clause given (its definitions section's heading carries no number the clause anchors placed) Application: text withheld (end not delimited: a term in an entry form that these rules did not read as a definition lies before the next definition read)
In normative sentences
15 sentences in 7 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.
- Regulation (EU) 2026/1744
EU1 sentence; text first observedarticle-1/9: 1 sentence (shall) - EU IVDR
EU4 sentences; text first observedannex-vii/4.3: 1 sentence (shall) ·annex-viii/1.1: 1 sentence (shall) ·annex-x/2: 1 sentence (shall) ·annex-xiv/chapter-i/1: 1 sentence (shall) - EU Machinery Regulation
EU2 sentences; text first observedannex-iii/part-b/5: 1 sentence (shall) ·annex-vii/3: 1 sentence (shall) - EU MDR
EU5 sentences; text first observedannex-vi/part-c/6.5.4: 1 sentence (shall) ·annex-vii/4.3: 1 sentence (shall) ·annex-viii/chapter-ii: 1 sentence (shall) ·annex-x/2: 1 sentence (shall) ·annex-xv/chapter-ii/1: 1 sentence (shall) - FDA AI guidance
US1 sentence; text first observed7: 1 sentence (should) - FDA device cybersecurity (2026)
US1 sentence; text first observed6: 1 sentence (should) - ICH Q12
International1 sentence; text first observed4: 1 sentence (should)
In titles
2 tracked rows whose titles print one of the forms in the heading, read from the title this record holds, by the same exact rule.
- Part 11, Electronic Records; Electronic Signatures — Scope and Application
US - ISO 14971 — Application of risk management to medical devices
International
In body
62 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.
- EU AI Act
EU1 occurrence; text first observedchapter-iii/section-4/article-29: 1 - EU Cyber Resilience Act
EU2 occurrences; text first observedannex-iii/15: 1 ·chapter-iv/article-42: 1 - EU GMP Annex 11 (draft)
EU1 occurrence; text first observed17.5: 1 - EU GMP Annex 2
EU1 occurrence; text first observed1: 1 - EU IVDR
EU3 occurrences; text first observedchapter-iv/article-34: 1 ·chapter-vi/article-66: 1 · 1 where no heading is read before it - EU Machinery Regulation
EU2 occurrences; text first observedannex-iii/part-b/5: 1 ·chapter-v/article-33: 1 - EU MDR
EU5 occurrences; text first observedannex-xi/part-a: 1 ·annex-xi/part-b: 1 ·chapter-iv/article-38: 1 ·chapter-vi/article-70: 1 · 1 where no heading is read before it - FDA AI guidance
US2 occurrences; text first observed7: 2 - FDA AI device list
US23 occurrences; text first observed23 where no numbering read in this text - FDA device cybersecurity (2026)
US2 occurrences; text first observed6: 2 - FDA electronic systems (clinical)
US2 occurrences; text first observed1: 1 · 1 where no heading is read before it - FDA guidance agenda
US4 occurrences; text first observed4 where no numbering read in this text - FDA Part 11 scope
US4 occurrences; text first observed4 where no numbering read in this text - ICH Q12
International3 occurrences; text first observed4: 3 - ICH Q9(R1)
International3 occurrences; text first observed10: 1 ·15: 1 ·9: 1 - NIST AI RMF
International3 occurrences; text first observed2: 1 ·6: 2 - NISTIR 8183
US1 occurrence; text first observed7: 1
Co-occurrence
112 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. 35 positions of this term have no placed clause and share none (a defining occurrence inside a sentence above is counted once under each).
- Act 3 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124 - Agency 3 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124 - AI Office 1 clause:
eu-digital-omnibus-aiarticle-1/9 - AI system 1 clause:
nist-ai-rmf6 - allow-list 1 clause:
fda-device-cybersecurity-20266 - authorised representative 10 clauses:
eu-ivdrannex-vii/4.3·annex-x/2·annex-xiv/chapter-i/1;eu-machinery-regulationannex-iii/part-b/5·annex-vii/3;eu-mdrannex-vii/4.3·annex-x/2·annex-xi/part-a·annex-xi/part-b·annex-xv/chapter-ii/1 - Autonomous mobile machinery 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - biometric identification 1 clause:
eu-digital-omnibus-aiarticle-1/9 - Carrier 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - chains 2 clauses:
eu-machinery-regulationannex-iii/part-b/5;ich-q124 - clinical evaluation 1 clause:
eu-mdrannex-xv/chapter-ii/1 - clinical investigation 2 clauses:
eu-mdrannex-xv/chapter-ii/1;fda-ai-guidance7 - clinical investigation plan 1 clause:
eu-mdrannex-xv/chapter-ii/1 - clinical performance 1 clause:
eu-ivdrannex-xiv/chapter-i/1 - Component / component 5 clauses:
eu-gmp-annex-11-draft17.5;eu-machinery-regulationannex-iii/part-b/5;fda-ai-guidance7;fda-device-cybersecurity-20266;nistir-81837 - conformity assessment 8 clauses:
eu-ai-actchapter-iii/section-4/article-29;eu-digital-omnibus-aiarticle-1/9;eu-ivdrannex-vii/4.3·chapter-iv/article-34;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-vii/4.3·annex-xi/part-a·chapter-iv/article-38 - conformity assessment body 1 clause:
eu-ai-actchapter-iii/section-4/article-29 - consumer 1 clause:
nistir-81837 - corrective action 2 clauses:
fda-device-cybersecurity-20266;ich-q124 - critical infrastructure 1 clause:
nistir-81837 - cyber threat 1 clause:
fda-device-cybersecurity-20266 - cybersecurity 4 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-rmf6;nistir-81837 - cybersecurity risk 4 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-rmf6;nistir-81837 - danger zone 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - deployer 1 clause:
eu-digital-omnibus-aiarticle-1/9 - derivative 3 clauses:
eu-mdrannex-xi/part-a·annex-xi/part-b·annex-xv/chapter-ii/1 - device for performance study 1 clause:
eu-ivdrannex-xiv/chapter-i/1 - device software function 1 clause:
fda-device-cybersecurity-20266 - Driver 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - Dynamic test 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - Electronic record 1 clause:
eu-gmp-annex-11-draft17.5 - end-to-end 1 clause:
fda-device-cybersecurity-20266 - entity 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - essential health and safety requirements 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - ethics committee 2 clauses:
eu-ivdrannex-xiv/chapter-i/1;eu-mdrannex-xv/chapter-ii/1 - Federal Food, Drug, and Cosmetic Act 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - guard 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - Guided load 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - hardware 4 clauses:
eu-gmp-annex-11-draft17.5;eu-machinery-regulationannex-iii/part-b/5;fda-device-cybersecurity-20266;nistir-81837 - Harm 1 clause:
fda-device-cybersecurity-20266 - harmonised standard 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - Hazard / hazard 3 clauses:
eu-machinery-regulationannex-iii/part-b/5;ich-q9r115·9 - identity management 1 clause:
fda-device-cybersecurity-20266 - incident 2 clauses:
fda-device-cybersecurity-20266;nistir-81837 - incident handling 1 clause:
nistir-81837 - informed consent 1 clause:
fda-device-cybersecurity-20266 - instructions for use 2 clauses:
eu-ivdrannex-x/2;eu-machinery-regulationannex-iii/part-b/5 - intended purpose 3 clauses:
eu-ivdrannex-viii/1.1·annex-x/2;eu-mdrannex-viii/chapter-ii - intended use 4 clauses:
eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-xi/part-a;fda-ai-guidance7;fda-device-cybersecurity-20266 - interchangeable equipment 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - investigational device 1 clause:
eu-mdrannex-xv/chapter-ii/1 - investigator 2 clauses:
eu-ivdrannex-xiv/chapter-i/1;eu-mdrannex-xv/chapter-ii/1 - label 1 clause:
eu-ivdrannex-x/2 - lifetime 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - lifting accessory 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - Lifting operation 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - machinery 3 clauses:
eu-digital-omnibus-aiarticle-1/9;eu-machinery-regulationannex-iii/part-b/5·annex-vii/3 - Machinery or related products for plant protection products application 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - Machinery or related products presenting risks due to their mobility 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - manufacturer 15 clauses:
eu-ivdrannex-vii/4.3·annex-x/2·annex-xiv/chapter-i/1;eu-machinery-regulationannex-iii/part-b/5·annex-vii/3;eu-mdrannex-vii/4.3·annex-viii/chapter-ii·annex-x/2·annex-xi/part-a·annex-xi/part-b·annex-xv/chapter-ii/1;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;nistir-81837 - market surveillance 2 clauses:
eu-digital-omnibus-aiarticle-1/9;eu-mdrannex-xi/part-b - market surveillance authority 1 clause:
eu-digital-omnibus-aiarticle-1/9 - medical device 3 clauses:
eu-mdrannex-viii/chapter-ii;fda-ai-guidance7;fda-device-cybersecurity-20266 - national competent authority 1 clause:
eu-digital-omnibus-aiarticle-1/9 - non-viable 1 clause:
eu-mdrannex-xv/chapter-ii/1 - notified body 9 clauses:
eu-ivdrannex-vii/4.3·annex-x/2·annex-xiv/chapter-i/1;eu-machinery-regulationannex-vii/3;eu-mdrannex-vii/4.3·annex-x/2·annex-xi/part-a·annex-xi/part-b·annex-xv/chapter-ii/1 - operator 5 clauses:
eu-digital-omnibus-aiarticle-1/9;eu-machinery-regulationannex-iii/part-b/5;fda-device-cybersecurity-20266;nist-ai-rmf6;nistir-81837 - partly completed machinery 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - performance 9 clauses:
eu-gmp-annex-11-draft17.5;eu-ivdrannex-xiv/chapter-i/1·chapter-vi/article-66;eu-machinery-regulationannex-iii/part-b/5;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;nist-ai-rmf6;nistir-81837 - performance evaluation 1 clause:
eu-ivdrannex-xiv/chapter-i/1 - performance study 1 clause:
eu-ivdrannex-xiv/chapter-i/1 - performance study plan 1 clause:
eu-ivdrannex-xiv/chapter-i/1 - placing on the market 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - post-market surveillance 1 clause:
eu-mdrannex-xi/part-b - Product Lifecycle 2 clauses:
fda-ai-guidance7;ich-q124 - protective device 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - provider 3 clauses:
eu-digital-omnibus-aiarticle-1/9;fda-device-cybersecurity-20266;nistir-81837 - putting into service 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - Quality 5 clauses:
eu-mdrannex-xi/part-a;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;nistir-81837 - Quality Risk Management 2 clauses:
fda-ai-guidance7;ich-q124 - Quality System 3 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124 - reasonably foreseeable misuse 2 clauses:
eu-machinery-regulationannex-iii/part-b/5;fda-device-cybersecurity-20266 - recall 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - removable mechanical transmission device 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - representative 14 clauses:
eu-ivdrannex-vii/4.3·annex-x/2·annex-xiv/chapter-i/1;eu-machinery-regulationannex-iii/part-b/5·annex-vii/3;eu-mdrannex-vii/4.3·annex-x/2·annex-xi/part-a·annex-xi/part-b·annex-xv/chapter-ii/1;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;nistir-81837 - Requirements 4 clauses:
eu-machinery-regulationannex-iii/part-b/5;fda-device-cybersecurity-20266;ich-q124;nistir-81837 - Risk / risk 9 clauses:
eu-digital-omnibus-aiarticle-1/9;eu-machinery-regulationannex-iii/part-b/5;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;ich-q9r110;nist-ai-rmf2·6;nistir-81837 - Risk Assessment 3 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266;nistir-81837 - Risk Management 5 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;nist-ai-rmf6;nistir-81837 - ropes 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - safety function 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - significant cybersecurity risk 1 clause:
fda-device-cybersecurity-20266 - SME 1 clause:
nist-ai-rmf6 - software 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 - source code 1 clause:
fda-device-cybersecurity-20266 - sponsor 4 clauses:
eu-ivdrannex-xiv/chapter-i/1;eu-mdrannex-xv/chapter-ii/1;fda-ai-guidance7;fda-device-cybersecurity-20266 - standard 6 clauses:
eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-vi/part-c/6.5.4·annex-xi/part-b;fda-ai-guidance7;fda-device-cybersecurity-20266;nist-ai-rmf6 - Static test 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - subject 9 clauses:
eu-digital-omnibus-aiarticle-1/9;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-xi/part-a·annex-xi/part-b·annex-xv/chapter-ii/1;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;nist-ai-rmf6 - Supervisor 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - Supervisory function 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - System / system 12 clauses:
eu-gmp-annex-11-draft17.5;eu-ivdrannex-vii/4.3;eu-machinery-regulationannex-iii/part-b/5;eu-mdrannex-vi/part-c/6.5.4·annex-vii/4.3·annex-xi/part-a·annex-xi/part-b;fda-ai-guidance7;fda-device-cybersecurity-20266;ich-q124;nist-ai-rmf6;nistir-81837 - Test coefficient 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - training data 1 clause:
fda-ai-guidance7 - UDI 2 clauses:
eu-mdrannex-vi/part-c/6.5.4;fda-device-cybersecurity-20266 - Union harmonisation legislation 2 clauses:
eu-digital-omnibus-aiarticle-1/9;eu-machinery-regulationannex-iii/part-b/5 - user 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 - validation data 1 clause:
ich-q124 - vulnerability 2 clauses:
fda-device-cybersecurity-20266;nistir-81837 - webbing 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - Working coefficient 1 clause:
eu-machinery-regulationannex-iii/part-b/5 - written 8 clauses:
eu-ivdrannex-vii/4.3·annex-x/2;eu-machinery-regulationannex-iii/part-b/5·annex-vii/3;eu-mdrannex-vii/4.3·annex-x/2·annex-xi/part-a;ich-q124
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 |
|---|---|---|---|---|
58dbc3006d27 | 0 | 0 | 1 | |
9d16077b1d3b (current) | 0 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
9206a43954eb (current) | 0 | 0 | 2 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
92eb86f25281 (current) | 0 | 1 | 0 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
797a882ba0ea | 0 | 0 | 0 | |
53742d793b68 (current) | 1 | 0 | 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 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
053f731102ad unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
c1a1d8a7fee4 (current) | 0 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
903e40aaebe6 (current) | 0 | 4 | 3 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
1fc20ae2ffd8 | 0 | 2 | 2 | |
82fb682a6c54 (current) | 0 | 2 | 2 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
14d00b77d5c8 | 0 | 5 | 5 | |
fab624c8e1dc (current) | 0 | 5 | 5 |
| 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 | 2 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
7d8bfb6d13ca | 0 | 0 | 21 | |
a55b6f369034 | 0 | 0 | 23 | |
f0d90446093e (current) | 0 | 0 | 23 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
b52b706d5cca (current) | 0 | 0 | 0 | |
d34d8c706d88 | 0 | 1 | 2 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
b52b706d5cca | 0 | 0 | 0 | |
27c5d1a28e3d unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
d34d8c706d88 (current) | 0 | 1 | 2 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
06b24bf9ebcb unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
74c586849092 (current) | 0 | 0 | 2 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
f5e8806992b5 | 0 | 0 | 0 | |
ae6842a2cdd8 (current) | 0 | 0 | 4 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
a5590943862c (current) | 0 | 0 | 4 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
206fc2d61445 (current) | 0 | 1 | 3 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
57c484f5daed (current) | 0 | 0 | 3 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
8afebcc0941a | 0 | 0 | 0 | |
c240f2675bd3 | 0 | 0 | 0 | |
4c10dc03228b (current) | 0 | 0 | 3 |
| 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 | 1 |
Feed
/atom/term/application.atom carries one entry for each text of a row whose counts above differ from the row’s previous text, and one for the first text of a row holding the term, dated by the text’s first observation. A new version of the derivation is a change of method and is never an entry.
How this page is derived
From the terms-index derivation’s current version, first derived on
, read from
state/terms-index.jsonl. Threshold: a key enters the index when at least 1 observed text of a tracked row defines it, under the definitions derivation's current version. Its version, its rules and
term set, and the versions of the clause-anchor, definitions and sentence derivations it joins, are on
the derivation methods page, which lists every version of each with
the day it was first derived: a change there is a change of method, never a change in a text.
Not read: a term printed in a form no definition under its key carries: a plural or other ending, another letter case, another spacing or a line break between its words, a hyphenated or abbreviated form, a translation; a term a document defines in a form head 3's rules do not read (its own not_reached names them), which enters no key; an occurrence in a text head 1 refused, which is not read; a title is read for its row and is not dated by a text. A position states where an occurrence lies in a text and nothing about what the text says of the term.
| Entry | text_retained | licence_class | quote_allowed | snapshot_available |
|---|---|---|---|---|
| EU GMP Annex 11 | 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 Cyber Resilience Act | true | open | true | true |
| EU IVDR | true | open | true | true |
| EU Machinery Regulation | true | open | true | true |
| EU MDR | true | open | true | true |
| 21 CFR Part 820 (QMSR) | true | open | true | true |
| EU Cybersecurity Act | true | open | true | true |
| EU NIS2 Directive | true | open | true | true |
| ICH Q9(R1) | true | open | true | true |
| Regulation (EU) 2026/1744 | true | open | true | true |
| ICH Q13 | true | open | true | true |
| 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: