GxPlex

manufacturer

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 4 definitions in this view are quoted and 4 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 (13): text withheld (over the cap: its term and text are 41 words)
EU IVDR
chapter-i/section-1/article-2 (23): text withheld (over the cap: its term and text are 33 words)
EU Machinery Regulation
chapter-i/article-3 (18): text withheld (over the cap: its term and text are 54 words)
EU MDR
chapter-i/article-2 (30): text withheld (over the cap: its term and text are 32 words)
Rows printing it in a normative sentence
30
Rows printing it in a title
0
Rows printing it in body
21

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
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
5
Rows printing it in a title
0
Rows printing it in body
4

This form is printed by the tracked documents, each as a document defines it. The index’s key is manufacturer (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

4 definitions in 4 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

1055 sentences in 37 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

178 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.

Co-occurrence

252 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. 139 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
DI revision concept paper
First observedTextDefinedIn normative sentencesIn body
208b17ec5cbe022
4f4cdfc13143 (current)022
EU AI Act
First observedTextDefinedIn normative sentencesIn body
58dbc3006d27040
9d16077b1d3b (current)040
EU Cyber Resilience Act
First observedTextDefinedIn normative sentencesIn body
9206a43954eb (current)114637
EU Cybersecurity Act
First observedTextDefinedIn normative sentencesIn body
1fe6027daa2c (current)0123
Regulation (EU) 2026/1744
First observedTextDefinedIn normative sentencesIn body
92eb86f25281 (current)020
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)0182
EU GMP Annex 10
First observedTextDefinedIn normative sentencesIn body
1bf6c7c62112 unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
f7881a52f0ad (current)001
EU GMP Annex 11
First observedTextDefinedIn normative sentencesIn body
797a882ba0ea000
53742d793b68 (current)010
ac0054416554000
749c40132375000
f110d5d47c11000
bf56cba791d8000
3db9896305a6000
EU GMP Annex 12
First observedTextDefinedIn normative sentencesIn body
791686510e26 unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
b3718fa9a670 (current)013
EU GMP Annex 13
First observedTextDefinedIn normative sentencesIn body
48f21f2e4f1b unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
c4635c9c95ba (current)0236
EU GMP Annex 14
First observedTextDefinedIn normative sentencesIn body
6eabc41e8879 unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
ea32c21545ee (current)0131
EU GMP Annex 15
First observedTextDefinedIn normative sentencesIn body
50a728365a3b unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
db59da980bed (current)031
EU GMP Annex 16
First observedTextDefinedIn normative sentencesIn body
c69969906e63 unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
2f7bb1a97c67 (current)002
EU GMP Annex 17
First observedTextDefinedIn normative sentencesIn body
d15b6167fee9 unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
507358780b13 (current)010
EU GMP Annex 19
First observedTextDefinedIn normative sentencesIn body
4aafde337ab3 unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
fecd3a76fef8 (current)085
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)031
EU GMP Annex 21
First observedTextDefinedIn normative sentencesIn body
45769b002c01 unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
6e2055f21776 (current)030
EU GMP Annex 3
First observedTextDefinedIn normative sentencesIn body
2cb8ccdb053c unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
743cfcdd11a7 (current)010
EU GMP Annex 6
First observedTextDefinedIn normative sentencesIn body
10131cf8966a unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
1787513e049d (current)021
EU GMP Annex 7
First observedTextDefinedIn normative sentencesIn body
e6dfb22ae579 unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
fd6b0dfbb7fd (current)040
EU GMP Annex 8
First observedTextDefinedIn normative sentencesIn body
04e1593f805c unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
1be3d183419f (current)025
EU GMP Chapter 1
First observedTextDefinedIn normative sentencesIn body
0c75116285b8 unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
cfea967f8325 (current)020
EU GMP Chapter 2
First observedTextDefinedIn normative sentencesIn body
6d54bcfeb8e7 unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
313242556edd (current)050
EU GMP Chapter 4
First observedTextDefinedIn normative sentencesIn body
ef49f58a80fe unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
b9143ae11461 (current)021
EU GMP Chapter 4 (draft)
First observedTextDefinedIn normative sentencesIn body
85a680107f4d unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
8f04120f403b (current)001
EU GMP Chapter 5
First observedTextDefinedIn normative sentencesIn body
f30eb798ed40 unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
172395cf624f (current)0130
EU GMP Chapter 6
First observedTextDefinedIn normative sentencesIn body
2ebf88652dc3 unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
6ec505fc00ef (current)011
EU GMP Chapter 7
First observedTextDefinedIn normative sentencesIn body
723340abc9bd unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
d5d92da2b929 (current)010
EU GMP Chapter 8
First observedTextDefinedIn normative sentencesIn body
6af0146c0d0b unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
880033e05d95 (current)030
EU IVDR
First observedTextDefinedIn normative sentencesIn body
903e40aaebe6 (current)128731
EU Machinery Regulation
First observedTextDefinedIn normative sentencesIn body
1fc20ae2ffd8113018
82fb682a6c54 (current)113018
EU MDR
First observedTextDefinedIn normative sentencesIn body
14d00b77d5c8130320
fab624c8e1dc (current)130320
EU NIS2 Directive
First observedTextDefinedIn normative sentencesIn body
023dc18395dc (current)031
FDA AI guidance
First observedTextDefinedIn normative sentencesIn body
61d4603ff66e000
088a7a37c55d000
630bd27c7b42000
5c61f4c6351d (current)021
FDA device cybersecurity
First observedTextDefinedIn normative sentencesIn body
b52b706d5cca (current)000
d34d8c706d8803417
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)03417
ICH Q12
First observedTextDefinedIn normative sentencesIn body
206fc2d61445 (current)010
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)0213
21 CFR Part 211
First observedTextDefinedIn normative sentencesIn body
393b48f902b8050
5997ebbb6661050
9d7b6d9aa4e1050
18e04a0c925a050
1e7f13684129050
f24b92ecdf42050
b670ac9656b7050
bc527e48bcd8050
4edb9480421c050
cd3e1c0c936b050
75605421c92f (current)050
21 CFR Part 820 (QMSR)
First observedTextDefinedIn normative sentencesIn body
8b8ac787c6870113
fa65ecef3a810113
8ee8e1aad0a50113
f3605b69e1360113
baa155d883e30113
ac6e97a3c75d0113
bb66b9cbb2c40113
0e1bbcb2d14d0113
0eb9eade18680113
94a77d5625e80113
ca64082d7f23 (current)0113

Feed

/atom/term/manufacturer.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 IVDRtrueopentruetrue
EU Machinery Regulationtrueopentruetrue
EU MDRtrueopentruetrue
EU Cybersecurity Acttrueopentruetrue
21 CFR Part 11trueopentruetrue
EU AI Acttrueopentruetrue
EU GMP Annex 22trueopentruetrue
FDA device cybersecuritytrueopentruetrue
FDA device cybersecurity (2026)trueopentruetrue
EU GMP Annex 11trueopentruetrue
FDA electronic systems (clinical)trueopentruetrue
21 CFR Part 820 (QMSR)trueopentruetrue
EU NIS2 Directivetrueopentruetrue
ICH Q9(R1)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: