GxPlex

medical device

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: 0 of 2 definitions in this view are quoted and 2 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

Canada

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

EU

Defined in
EU IVDR
chapter-i/section-1/article-2 (1): text withheld (over the cap: its term and text are 17 words)
EU MDR
chapter-i/article-2 (1): text withheld (over the cap: its term and text are 183 words)
Rows printing it in a normative sentence
4
Rows printing it in a title
0
Rows printing it in body
1

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
2

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
6

This form is printed by the tracked documents, each as a document defines it. The index’s key is medical device (the definitions derivation’s fold: case set aside, spaces collapsed; each form is matched exactly as printed). 3 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

2 definitions in 2 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

76 sentences in 6 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

3 tracked rows whose titles print one of the forms in the heading, read from the title this record holds, by the same exact rule.

In body

74 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

132 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).

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.

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)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)010
EU IVDR
First observedTextDefinedIn normative sentencesIn body
903e40aaebe6 (current)1133
EU MDR
First observedTextDefinedIn normative sentencesIn body
14d00b77d5c81190
fab624c8e1dc (current)1190
FDA AI guidance
First observedTextDefinedIn normative sentencesIn body
61d4603ff66e000
088a7a37c55d000
630bd27c7b42000
5c61f4c6351d (current)001
FDA AI device list
First observedTextDefinedIn normative sentencesIn body
7d8bfb6d13ca002
a55b6f369034002
f0d90446093e (current)002
FDA CSA
First observedTextDefinedIn normative sentencesIn body
4843091843f0 (current)001
FDA device cybersecurity
First observedTextDefinedIn normative sentencesIn body
b52b706d5cca (current)000
d34d8c706d8803748
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)03748
FDA software validation
First observedTextDefinedIn normative sentencesIn body
c49d3a719515 (current)001
Health Canada ML
First observedTextDefinedIn normative sentencesIn body
2988351a10190012
f34e637e74cb (current)0012
MHRA AI
First observedTextDefinedIn normative sentencesIn body
110d6c8e7c56003
d4b6bb0450a8003
0d4b2abb3a4f003
8fc70fdfe3a5003
95ff73c7efa2003
21fde7c052b4003
d722379e4120003
f61cf3af5063003
adda145eadf9 (current)003
MHRA AI Airlock
First observedTextDefinedIn normative sentencesIn body
7337fc5e71ae002
6e98d69dcbc7002
5ccba04e90a2002
aa1a23f2db97002
dd2f48968ac3002
6f27b489239b002
d1d2dd4818e2002
a16f7063df22002
53985e50d069002
2cf39acc83b7002
0465b20f61c7 (current)002
21 CFR Part 820 (QMSR)
First observedTextDefinedIn normative sentencesIn body
8b8ac787c687051
fa65ecef3a81051
8ee8e1aad0a5051
f3605b69e136051
baa155d883e3051
ac6e97a3c75d051
bb66b9cbb2c4051
0e1bbcb2d14d051
0eb9eade1868051
94a77d5625e8051
ca64082d7f23 (current)051

Feed

/atom/term/medical-device.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 IVDRtrueopentruetrue
EU MDRtrueopentruetrue
21 CFR Part 11trueopentruetrue
FDA device cybersecuritytrueopentruetrue
FDA device cybersecurity (2026)trueopentruetrue
EU GMP Annex 11trueopentruetrue
EU AI Acttrueopentruetrue
EU Cyber Resilience Acttrueopentruetrue
EU Machinery Regulationtrueopentruetrue
21 CFR Part 820 (QMSR)trueopentruetrue
EU Cybersecurity Acttrueopentruetrue
EU NIS2 Directivetrueopentruetrue
ICH Q9(R1)trueopentruetrue
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: