GxPlex

incident

shared term, no equivalence asserted

The rows below print this term in 4 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 5 definitions in this view are quoted and 5 are withheld with the reason. No reading here says that two of them agree or differ.

EU

Defined in
EU Cyber Resilience Act
chapter-i/article-3 (43): text withheld (end not delimited: a number and a quoted term that these rules do not read as a definition lie before the next definition read)
EU Cybersecurity Act
title-i/article-2 (6): text withheld (over the cap: its term and text are 16 words)
EU IVDR
chapter-i/section-1/article-2 (67): text withheld (over the cap: its term and text are 63 words)
EU MDR
chapter-i/article-2 (64): text withheld (over the cap: its term and text are 41 words)
EU NIS2 Directive
chapter-i/article-6 (6): text withheld (over the cap: its term and text are 30 words)
Rows printing it in a normative sentence
11
Rows printing it in a title
0
Rows printing it in body
5

International

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
0
Rows printing it in body
1

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
0
Rows printing it in body
1

US

Defined in
no current text of a row of this jurisdiction defines it
Rows printing it in a normative sentence
2
Rows printing it in a title
0
Rows printing it in body
3

This form is printed by the tracked documents, each as a document defines it. The index’s key is incident (the definitions derivation’s fold: case set aside, spaces collapsed; each form is matched exactly as printed). 6 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

5 definitions in 5 current texts, as the definitions derivation’s rules read them, quoted where the term and its text together sit under the quote cap.

In normative sentences

166 sentences in 13 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.

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

70 occurrences in 10 current texts outside every sentence above and outside the term’s own definitions, each counted under the clause anchor the clause-anchor derivation placed last before it; each clause is followed by its count.

Co-occurrence

247 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. 59 positions of this term have no placed clause and share none (a defining occurrence inside a sentence above is counted once under each).

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.

EMA CT computerised systems
First observedTextDefinedIn normative sentencesIn body
90f72782b398 unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
ebaf707c409d (current)011
EU AI Act
First observedTextDefinedIn normative sentencesIn body
58dbc3006d270190
9d16077b1d3b (current)0190
EU Cyber Resilience Act
First observedTextDefinedIn normative sentencesIn body
9206a43954eb (current)1223
EU Cybersecurity Act
First observedTextDefinedIn normative sentencesIn body
1fe6027daa2c (current)165
EU GMP Annex 1
First observedTextDefinedIn normative sentencesIn body
2f3d52a59156 unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
1d99797d3b8b (current)010
EU GMP Annex 11
First observedTextDefinedIn normative sentencesIn body
797a882ba0ea000
53742d793b68 (current)010
ac0054416554000
749c40132375000
f110d5d47c11000
bf56cba791d8000
3db9896305a6000
EU GMP Annex 11 (draft)
First observedTextDefinedIn normative sentencesIn body
0e885238d69a unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
7a8b8a6e95d5 (current)031
EU GMP Annex 2
First observedTextDefinedIn normative sentencesIn body
053f731102ad unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
c1a1d8a7fee4 (current)020
EU IVDR
First observedTextDefinedIn normative sentencesIn body
903e40aaebe6 (current)1240
EU MDR
First observedTextDefinedIn normative sentencesIn body
14d00b77d5c81260
fab624c8e1dc (current)1260
EU NIS2 Directive
First observedTextDefinedIn normative sentencesIn body
023dc18395dc (current)1588
FDA device cybersecurity
First observedTextDefinedIn normative sentencesIn body
b52b706d5cca (current)000
d34d8c706d88022
FDA device cybersecurity (2026)
First observedTextDefinedIn normative sentencesIn body
b52b706d5cca000
27c5d1a28e3d unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
d34d8c706d88 (current)022
MHRA AI
First observedTextDefinedIn normative sentencesIn body
110d6c8e7c56001
d4b6bb0450a8001
0d4b2abb3a4f001
8fc70fdfe3a5001
95ff73c7efa2001
21fde7c052b4001
d722379e4120001
f61cf3af5063001
adda145eadf9 (current)001
NIST AI 600-1
First observedTextDefinedIn normative sentencesIn body
a5ad5867c187 unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
caa03fc84948 (current)0130
NIST AI RMF
First observedTextDefinedIn normative sentencesIn body
8afebcc0941a000
c240f2675bd3000
4c10dc03228b (current)001
NISTIR 8183
First observedTextDefinedIn normative sentencesIn body
92b7bfe588c4 unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
fe392d207918 (current)0018

Feed

/atom/term/incident.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.

Rights envelope — how this record handles the text of each entry listed
Entrytext_retainedlicence_classquote_allowedsnapshot_available
EU Cyber Resilience Acttrueopentruetrue
EU Cybersecurity Acttrueopentruetrue
EU IVDRtrueopentruetrue
EU MDRtrueopentruetrue
EU NIS2 Directivetrueopentruetrue
EU Machinery Regulationtrueopentruetrue
21 CFR Part 11trueopentruetrue
EU AI Acttrueopentruetrue
EU GMP Annex 22trueopentruetrue
FDA device cybersecuritytrueopentruetrue
FDA device cybersecurity (2026)trueopentruetrue
EU GMP Annex 11trueopentruetrue
21 CFR Part 820 (QMSR)trueopentruetrue
ICH Q9(R1)trueopentruetrue
FDA electronic systems (clinical)trueopentruetrue
Regulation (EU) 2026/1744trueopentruetrue
ICH Q13trueopentruetrue
EU GMP Chapter 4trueopentruetrue

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: