national competent authority

shared term, no equivalence asserted

The rows below print this term in 2 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 AI Act
chapter-i/article-3 (48): text withheld (over the cap: its term and text are 51 words)
Rows printing it in a normative sentence: 7
Rows printing it in a title: 0
Rows printing it in body: 0

International

Defined in: no current text of a row of this jurisdiction defines it
Rows printing it in a normative sentence: 1
Rows printing it in a title: 0
Rows printing it in body: 1

This form is printed by the tracked documents, each as a document defines it. The index’s key is national competent authority (the definitions derivation’s fold: case set aside, spaces collapsed; each form is matched exactly as printed). 2 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

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 AI Act EU text first observed 2026-08-03
- chapter-i/article-3 (48) national competent authority: text withheld (over the cap: its term and text are 51 words)

In normative sentences

28 sentences in 8 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.

DI revision concept paper International 3 sentences; text first observed 2026-09-02
no numbering read: 3 sentences (must, may)
EU AI Act EU 11 sentences; text first observed 2026-08-03
chapter-i/article-3: 1 sentence (may, shall) · chapter-iii/section-3/article-16: 1 sentence (shall) · chapter-iii/section-4/article-36/9: 3 sentences (shall, may) · chapter-vi/article-57/7: 1 sentence (shall) · chapter-vi/article-57/8: 1 sentence (may) · chapter-vi/article-57/12: 1 sentence (shall) · chapter-vi/article-58/2: 1 sentence (shall, may) · chapter-ix/section-2/article-73/10: 1 sentence (shall) · chapter-ix/section-3/article-78/3: 1 sentence (shall)
Regulation (EU) 2026/1744 EU 4 sentences; text first observed 2026-08-04
no clause anchor before this sentence: 1 sentence (should) · article-1/6: 2 sentences (shall) · article-1/9: 1 sentence (shall)
EU GMP Annex 13 EU 1 sentence; text first observed 2026-09-08
7: 1 sentence (should)
EU GMP Annex 14 EU 1 sentence; text first observed 2026-09-08
10: 1 sentence (must)
EU GMP Annex 2 EU 1 sentence; text first observed 2026-09-08
36: 1 sentence (must, should)
EU IVDR EU 4 sentences; text first observed 2026-07-28
chapter-iv/article-31/6: 1 sentence (shall) · chapter-iv/article-42/6: 1 sentence (may, shall) · chapter-vii/section-2/article-84/3: 1 sentence (shall) · chapter-vii/section-2/article-84/6: 1 sentence (shall)
EU MDR EU 3 sentences; text first observed 2026-08-12
chapter-iv/article-35/6: 1 sentence (shall) · chapter-vii/section-2/article-89/3: 1 sentence (shall) · chapter-vii/section-2/article-89/6: 1 sentence (may, shall)

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

1 occurrence in 1 current text 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.

DI revision concept paper International 1 occurrence; text first observed 2026-09-02
1 where no numbering read in this text

Co-occurrence

102 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. 5 positions of this term have no placed clause and share none (a defining occurrence inside a sentence above is counted once under each).

adverse event 2 clauses: eu-gmp-annex-14 10; eu-gmp-annex-2 36
Agency 1 clause: eu-gmp-annex-14 10
AI literacy 1 clause: eu-ai-act chapter-i/article-3
AI Office 3 clauses: eu-ai-act chapter-i/article-3; eu-digital-omnibus-ai article-1/6 · article-1/9
AI regulatory sandbox 5 clauses: eu-ai-act chapter-i/article-3 · chapter-vi/article-57/12 · chapter-vi/article-57/7 · chapter-vi/article-58/2; eu-digital-omnibus-ai article-1/6
AI system 7 clauses: eu-ai-act chapter-i/article-3 · chapter-iii/section-3/article-16 · chapter-iii/section-4/article-36/9 · chapter-vi/article-57/12 · chapter-vi/article-57/7 · chapter-vi/article-58/2; eu-digital-omnibus-ai article-1/6
Application 1 clause: eu-digital-omnibus-ai article-1/9
authorised representative 1 clause: eu-ai-act chapter-i/article-3
biometric categorisation system 1 clause: eu-ai-act chapter-i/article-3
biometric data 1 clause: eu-ai-act chapter-i/article-3
biometric identification 2 clauses: eu-ai-act chapter-i/article-3; eu-digital-omnibus-ai article-1/9
biometric verification 1 clause: eu-ai-act chapter-i/article-3
CE marking 2 clauses: eu-ai-act chapter-i/article-3 · chapter-iii/section-3/article-16
chains 1 clause: eu-gmp-annex-2 36
clinical benefit 2 clauses: eu-ivdr chapter-vii/section-2/article-84/3; eu-mdr chapter-vii/section-2/article-89/3
Closed system 1 clause: eu-gmp-annex-2 36
common specification 1 clause: eu-ai-act chapter-i/article-3
companion diagnostic 1 clause: eu-ivdr chapter-vii/section-2/article-84/6
Component / component 3 clauses: eu-ai-act chapter-i/article-3; eu-gmp-annex-14 10; eu-gmp-annex-2 36
conformity assessment 6 clauses: eu-ai-act chapter-i/article-3 · chapter-iii/section-3/article-16 · chapter-vi/article-57/7 · chapter-vi/article-58/2; eu-digital-omnibus-ai article-1/6 · article-1/9
conformity assessment body 1 clause: eu-ai-act chapter-i/article-3
corrective action 3 clauses: eu-ivdr chapter-vii/section-2/article-84/3; eu-mdr chapter-vii/section-2/article-89/3 · chapter-vii/section-2/article-89/6
critical infrastructure 1 clause: eu-ai-act chapter-i/article-3
cybersecurity 1 clause: eu-ai-act chapter-vi/article-58/2
deep fake 1 clause: eu-ai-act chapter-i/article-3
deployer 4 clauses: eu-ai-act chapter-i/article-3 · chapter-ix/section-3/article-78/3; eu-digital-omnibus-ai article-1/6 · article-1/9
distributor 1 clause: eu-ai-act chapter-i/article-3
downstream provider 1 clause: eu-ai-act chapter-i/article-3
emotion recognition system 1 clause: eu-ai-act chapter-i/article-3
entity 2 clauses: eu-ai-act chapter-i/article-3; eu-gmp-annex-2 36
field safety corrective action 3 clauses: eu-ivdr chapter-vii/section-2/article-84/3; eu-mdr chapter-vii/section-2/article-89/3 · chapter-vii/section-2/article-89/6
floating-point operation 1 clause: eu-ai-act chapter-i/article-3
general-purpose AI model 1 clause: eu-ai-act chapter-i/article-3
general-purpose AI system 1 clause: eu-ai-act chapter-i/article-3
harmonised standard 1 clause: eu-ai-act chapter-i/article-3
high-impact capabilities 1 clause: eu-ai-act chapter-i/article-3
importer 2 clauses: eu-ai-act chapter-i/article-3; eu-gmp-annex-13 7
incident 6 clauses: eu-ai-act chapter-i/article-3 · chapter-ix/section-2/article-73/10; eu-gmp-annex-2 36; eu-ivdr chapter-vii/section-2/article-84/3; eu-mdr chapter-vii/section-2/article-89/3 · chapter-vii/section-2/article-89/6
informed consent 1 clause: eu-ai-act chapter-i/article-3
input data 1 clause: eu-ai-act chapter-i/article-3
instructions for use 1 clause: eu-ai-act chapter-i/article-3
intended purpose 2 clauses: eu-ai-act chapter-i/article-3; eu-gmp-annex-14 10
intended use 1 clause: eu-gmp-annex-2 36
law enforcement 3 clauses: eu-ai-act chapter-i/article-3 · chapter-ix/section-3/article-78/3; eu-digital-omnibus-ai article-1/6
law enforcement authority 1 clause: eu-ai-act chapter-i/article-3
machinery 1 clause: eu-digital-omnibus-ai article-1/9
making available on the market 1 clause: eu-ai-act chapter-i/article-3
manufacturer 7 clauses: eu-ai-act chapter-i/article-3; eu-gmp-annex-13 7; eu-gmp-annex-14 10; eu-gmp-annex-2 36; eu-ivdr chapter-iv/article-42/6 · chapter-vii/section-2/article-84/3; eu-mdr chapter-vii/section-2/article-89/3
market surveillance 6 clauses: eu-ai-act chapter-i/article-3 · chapter-ix/section-3/article-78/3 · chapter-vi/article-57/7; eu-digital-omnibus-ai article-1/6 · article-1/9; eu-ivdr chapter-iv/article-42/6
market surveillance authority 4 clauses: eu-ai-act chapter-i/article-3 · chapter-ix/section-3/article-78/3; eu-digital-omnibus-ai article-1/6 · article-1/9
medical device 1 clause: eu-gmp-annex-14 10
non-personal data 1 clause: eu-ai-act chapter-i/article-3
notified body 6 clauses: eu-ai-act chapter-i/article-3 · chapter-iii/section-4/article-36/9; eu-digital-omnibus-ai article-1/6; eu-ivdr chapter-iv/article-42/6 · chapter-vii/section-2/article-84/6; eu-mdr chapter-vii/section-2/article-89/6
notifying authority 1 clause: eu-ai-act chapter-i/article-3
online search engine 1 clause: eu-digital-omnibus-ai article-1/6
operator 4 clauses: eu-ai-act chapter-i/article-3; eu-digital-omnibus-ai article-1/6 · article-1/9; eu-gmp-annex-2 36
performance 5 clauses: eu-ai-act chapter-i/article-3; eu-digital-omnibus-ai article-1/6; eu-gmp-annex-2 36; eu-ivdr chapter-iv/article-31/6; eu-mdr chapter-iv/article-35/6
performance of an AI system 1 clause: eu-ai-act chapter-i/article-3
personal data 2 clauses: eu-ai-act chapter-i/article-3; eu-digital-omnibus-ai article-1/6
placing on the market 2 clauses: eu-ai-act chapter-i/article-3; eu-digital-omnibus-ai article-1/6
post-market monitoring system 2 clauses: eu-ai-act chapter-i/article-3; eu-digital-omnibus-ai article-1/6
post-remote biometric identification system 1 clause: eu-ai-act chapter-i/article-3
profiling 1 clause: eu-ai-act chapter-i/article-3
provider 7 clauses: eu-ai-act chapter-i/article-3 · chapter-iii/section-4/article-36/9 · chapter-vi/article-57/7 · chapter-vi/article-57/8 · chapter-vi/article-58/2; eu-digital-omnibus-ai article-1/6 · article-1/9
publicly accessible space 1 clause: eu-ai-act chapter-i/article-3
putting into service 2 clauses: eu-ai-act chapter-i/article-3; eu-digital-omnibus-ai article-1/6
Quality 3 clauses: eu-gmp-annex-13 7; eu-gmp-annex-14 10; eu-gmp-annex-2 36
real-time remote biometric identification system 1 clause: eu-ai-act chapter-i/article-3
real-world testing plan 2 clauses: eu-ai-act chapter-i/article-3; eu-digital-omnibus-ai article-1/6
reasonably foreseeable misuse 1 clause: eu-ai-act chapter-i/article-3
recall 3 clauses: eu-ai-act chapter-i/article-3; eu-digital-omnibus-ai article-1/6; eu-gmp-annex-2 36
recall of an AI system 1 clause: eu-ai-act chapter-i/article-3
remote biometric identification system 1 clause: eu-ai-act chapter-i/article-3
representative 3 clauses: eu-ai-act chapter-i/article-3; eu-digital-omnibus-ai article-1/6; eu-gmp-annex-2 36
reprocessing 1 clause: eu-gmp-annex-14 10
Requirements 1 clause: eu-gmp-annex-14 10
Risk / risk 12 clauses: eu-ai-act chapter-i/article-3 · chapter-iii/section-3/article-16 · chapter-iii/section-4/article-36/9 · chapter-ix/section-2/article-73/10 · chapter-ix/section-3/article-78/3; eu-digital-omnibus-ai article-1/6 · article-1/9; eu-gmp-annex-14 10; eu-gmp-annex-2 36; eu-ivdr chapter-iv/article-42/6 · chapter-vii/section-2/article-84/3; eu-mdr chapter-vii/section-2/article-89/3
safety component 1 clause: eu-ai-act chapter-i/article-3
safety function 1 clause: eu-ai-act chapter-i/article-3
sandbox plan 2 clauses: eu-ai-act chapter-i/article-3; eu-digital-omnibus-ai article-1/6
sensitive operational data 2 clauses: eu-ai-act chapter-i/article-3 · chapter-ix/section-3/article-78/3
serious adverse event 2 clauses: eu-gmp-annex-14 10; eu-gmp-annex-2 36
serious incident 4 clauses: eu-ai-act chapter-i/article-3; eu-ivdr chapter-vii/section-2/article-84/3; eu-mdr chapter-vii/section-2/article-89/3 · chapter-vii/section-2/article-89/6
special categories of personal data 1 clause: eu-ai-act chapter-i/article-3
sponsor 1 clause: eu-gmp-annex-13 7
standard 2 clauses: eu-ai-act chapter-i/article-3; eu-gmp-annex-14 10
subject 5 clauses: eu-ai-act chapter-i/article-3; eu-digital-omnibus-ai article-1/6 · article-1/9; eu-gmp-annex-14 10; eu-gmp-annex-2 36
substantial modification 1 clause: eu-ai-act chapter-i/article-3
Supervisor 3 clauses: eu-ai-act chapter-i/article-3 · chapter-vi/article-58/2; eu-digital-omnibus-ai article-1/6
System / system 11 clauses: eu-ai-act chapter-i/article-3 · chapter-iii/section-3/article-16 · chapter-iii/section-4/article-36/9 · chapter-vi/article-57/12 · chapter-vi/article-57/7 · chapter-vi/article-58/2; eu-digital-omnibus-ai article-1/6; eu-gmp-annex-13 7; eu-gmp-annex-14 10; eu-gmp-annex-2 36; eu-ivdr chapter-iv/article-42/6
systemic risk 1 clause: eu-ai-act chapter-i/article-3
technical specifications 1 clause: eu-ai-act chapter-i/article-3
testing data 1 clause: eu-ai-act chapter-i/article-3
testing in real-world conditions 2 clauses: eu-ai-act chapter-i/article-3; eu-digital-omnibus-ai article-1/6
training data 1 clause: eu-ai-act chapter-i/article-3
Union harmonisation legislation 3 clauses: eu-ai-act chapter-i/article-3; eu-digital-omnibus-ai article-1/6 · article-1/9
validation data 1 clause: eu-ai-act chapter-i/article-3
validation data set 1 clause: eu-ai-act chapter-i/article-3
widespread infringement 1 clause: eu-ai-act chapter-i/article-3
withdrawal 4 clauses: eu-ai-act chapter-i/article-3 · chapter-iii/section-4/article-36/9; eu-gmp-annex-14 10; eu-ivdr chapter-iv/article-42/6
withdrawal of an AI system 1 clause: eu-ai-act chapter-i/article-3
written 7 clauses: eu-ai-act chapter-i/article-3 · chapter-vi/article-57/7; eu-digital-omnibus-ai article-1/6; eu-gmp-annex-13 7; eu-gmp-annex-14 10; eu-gmp-annex-2 36; eu-ivdr chapter-iv/article-42/6

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.

DI revision concept paper
First observed	Text	Defined	In normative sentences	In body
2026-07-31	`208b17ec5cbe`	0	3	1
2026-09-02	`4f4cdfc13143` (current)	0	3	1

EU AI Act
First observed	Text	Defined	In normative sentences	In body
2026-07-28	`58dbc3006d27`	1	11	0
2026-08-03	`9d16077b1d3b` (current)	1	11	0

Regulation (EU) 2026/1744
First observed	Text	Defined	In normative sentences	In body
2026-08-04	`92eb86f25281` (current)	0	4	0

EU GMP Annex 13
First observed	Text	Defined	In normative sentences	In body
2026-08-15	`48f21f2e4f1b` unmeasured: the retained text opens with a PDF file signature ('%PDF-')	not measured	not measured	not measured
2026-09-08	`c4635c9c95ba` (current)	0	1	0

EU GMP Annex 14
First observed	Text	Defined	In normative sentences	In body
2026-08-15	`6eabc41e8879` unmeasured: the retained text opens with a PDF file signature ('%PDF-')	not measured	not measured	not measured
2026-09-08	`ea32c21545ee` (current)	0	1	0

EU GMP Annex 2
First observed	Text	Defined	In normative sentences	In body
2026-08-15	`053f731102ad` unmeasured: the retained text opens with a PDF file signature ('%PDF-')	not measured	not measured	not measured
2026-09-08	`c1a1d8a7fee4` (current)	0	1	0

EU IVDR
First observed	Text	Defined	In normative sentences	In body
2026-07-28	`903e40aaebe6` (current)	0	4	0

EU MDR
First observed	Text	Defined	In normative sentences	In body
2026-07-28	`14d00b77d5c8`	0	3	0
2026-08-12	`fab624c8e1dc` (current)	0	3	0

Feed

/atom/term/national-competent-authority.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 2026-10-31, 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.

Rights envelope — how this record handles the text of each entry listed
Entry	`text_retained`	`licence_class`	`quote_allowed`	`snapshot_available`
EU AI Act	`true`	`open`	`true`	`true`
EU IVDR	`true`	`open`	`true`	`true`
EU MDR	`true`	`open`	`true`	`true`
21 CFR Part 11	`true`	`open`	`true`	`true`
EU GMP Annex 22	`true`	`open`	`true`	`true`
EU GMP Annex 11	`true`	`open`	`true`	`true`
EU Cyber Resilience Act	`true`	`open`	`true`	`true`
EU Machinery Regulation	`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: 2 November 2026