GxPlex

Jurisdiction: EU

18 of 86 tracked instruments.

This is a projection of the tracker, not a separate dataset. Its canonical URL is the tracker.

Status unknown 2 frozen 5 final 3 in-force 8

Ordered by the lifecycle the values themselves name.

Subject (as stated) no self-stated subject 7 artificial intelligence 3 medical devices 2 computerised systems 2 quality management 1 trustworthiness 2 validation 1 clinical 1
+1 more in vitro diagnostic 1

Values match by containment: a document stating "information security" appears under "security", because one string contains the other and no mapping between words is applied.

Class (as stated) no self-stated class 5 consensus standard 4 authority guidance 4 legal act 5

The words a document uses about itself. One that uses none is filed under "no self-stated class" — a fact about the reading, not a kind of document.

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Showing 18 of 86 instruments. Clear all filters

Jurisdiction: EU — 18 instrument(s) — no change has been detected yet, so rows are alphabetical; they order by change date as soon as one is
Instrument Authority Jurisdiction Status Last verified Last changed Source
Annex 11 concept paper European Medicines Agency EU not yet verified awaiting link (opens in new tab)
CEN/CLC JTC 21 CEN/CENELEC EU not yet verified frozen not a document link (opens in new tab)
EMA AI reflection paper European Medicines Agency EU final check unrecorded 2026-07-28 link (opens in new tab) · retrieved
EMA CT computerised systems European Medicines Agency EU final verified 2026-08-01 link (opens in new tab) · retrieved
EMA work programme European Medicines Agency EU final verified 2026-07-28 link (opens in new tab) · retrieved
EU AI Act European Parliament and Council EU in force verified 2026-07-28 link (opens in new tab) · retrieved
EU Cyber Resilience Act European Parliament and Council EU in force tool-read 2026-07-31 link (opens in new tab) · retrieved
EU GMP Annex 11 European Commission EU in force verified 2026-07-30 link (opens in new tab) · retrieved
EU GMP Annex 15 European Commission EU in force tool-read 2026-07-31 link (opens in new tab) · retrieved
EU GMP Annex 22 European Commission EU not yet verified awaiting link (opens in new tab)
EU GMP Chapter 4 European Commission EU in force tool-read 2026-07-31 link (opens in new tab) · retrieved
EU IVDR European Parliament and Council EU in force verified 2026-07-28 link (opens in new tab) · retrieved
EU MDR European Parliament and Council EU in force verified 2026-07-28 link (opens in new tab) · retrieved
EU NIS2 Directive European Parliament and Council EU in force tool-read 2026-07-31 link (opens in new tab) · retrieved
prEN 18229-1 CEN/CENELEC JTC 21 EU not yet verified frozen paywalled — progression tracked link (opens in new tab)
prEN 18229-2 CEN/CENELEC JTC 21 EU not yet verified frozen paywalled — progression tracked link (opens in new tab)
prEN 18281 CEN/CENELEC JTC 21 EU not yet verified frozen paywalled — progression tracked link (opens in new tab)
prEN 18282 CEN/CENELEC JTC 21 EU not yet verified frozen paywalled — progression tracked link (opens in new tab)

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