GxPlex

Status: in-force

10 of 86 tracked instruments.

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

Jurisdiction EU 8 US 2

Ordered by count, then alphabetically.

Subject (as stated) no self-stated subject 3 artificial intelligence 1 medical devices 2 computerised systems 1 manufacturing 1 validation 1 electronic records 1 electronic signatures 1
+2 more good manufacturing practice 1 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 1 authority guidance 2 legal act 7

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.

Two facets compose at a time.

Showing 10 of 86 instruments. Clear all filters

Status: in-force — 10 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
21 CFR Part 11 US Food and Drug Administration US in force verified 2026-08-01 link (opens in new tab) · retrieved
21 CFR Part 211 US Food and Drug Administration US in force verified 2026-08-01 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 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

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