GxPlex

Class (as stated): no self-stated class

43 of 86 tracked instruments.

These documents state nothing about their own class in the text this site reads. That is a fact about the reading, not a category they belong to.

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

Status unknown 3 frozen 17 draft 3 final 19 in-force 1

Ordered by the lifecycle the values themselves name.

Class (as stated) no self-stated class 43 (active — select again to clear) consensus standard 24 authority guidance 12 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 43 of 86 instruments. Clear all filters

Class (as stated): no self-stated class — 43 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
ANVISA Agência Nacional de Vigilância Sanitária Brazil not yet verified frozen listing only link (opens in new tab)
CEN/CLC JTC 21 CEN/CENELEC EU not yet verified frozen not a document link (opens in new tab)
DI revision concept paper European Medicines Agency and Pharmaceutical Inspection Co-operation Scheme International not yet verified frozen listing only 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 GMP Chapter 4 European Commission EU in force tool-read 2026-07-31 link (opens in new tab) · retrieved
FDA AI device list US Food and Drug Administration US not yet verified frozen register states no status link (opens in new tab)
FDA AI guidance US Food and Drug Administration US draft — recorded as draft against the primary source verified 2026-07-30 link (opens in new tab) · retrieved
FDA CDRH AI/ML US Food and Drug Administration US draft — recorded as draft against the primary source verified 2026-07-30 link (opens in new tab) · retrieved
FDA CSA US Food and Drug Administration US final verified 2026-07-30 link (opens in new tab) · retrieved
FDA data integrity US Food and Drug Administration US final verified 2026-07-28 link (opens in new tab) · retrieved
FDA device cybersecurity US Food and Drug Administration US not yet verified awaiting link (opens in new tab)
FDA ETP US Food and Drug Administration US not yet verified frozen not a document link (opens in new tab)
FDA Part 11 scope US Food and Drug Administration US final tool-read 2026-07-31 link (opens in new tab) · retrieved
FDA PCCP US Food and Drug Administration US final verified 2026-07-28 link (opens in new tab) · retrieved
FDA process analytical framework US Food and Drug Administration US final tool-read 2026-07-31 link (opens in new tab) · retrieved
FDA software validation US Food and Drug Administration US final tool-read 2026-07-31 link (opens in new tab) · retrieved
FDA/EMA AI principles US Food and Drug Administration and European Medicines Agency International not yet verified awaiting link (opens in new tab)
GAMP 5 2nd Ed ISPE International not yet verified frozen paywalled — progression tracked link (opens in new tab)
Health Canada ML Health Canada Canada draft — under consultation verified 2026-07-28 link (opens in new tab) · retrieved
ICH E6(R3) International Council for Harmonisation International final verified 2026-07-29 link (opens in new tab) · retrieved
ICH Q12 International Council for Harmonisation International final verified 2026-07-29 link (opens in new tab) · retrieved
ICH Q13 International Council for Harmonisation International final verified 2026-07-29 link (opens in new tab) · retrieved
ICH Q14 International Council for Harmonisation International final verified 2026-07-29 link (opens in new tab) · retrieved
ICH Q2(R2) International Council for Harmonisation International final verified 2026-07-30 link (opens in new tab) · retrieved
ICH Q9(R1) International Council for Harmonisation International final verified 2026-07-29 link (opens in new tab) · retrieved
IMDRF AI/ML WG International Medical Device Regulators Forum International not yet verified frozen blocks automated requests link (opens in new tab)
IMDRF SaMD International Medical Device Regulators Forum International not yet verified frozen blocks automated requests link (opens in new tab)
ISPE Pharma 4.0 International Society for Pharmaceutical Engineering International not yet verified frozen not a document link (opens in new tab)
MHRA AI Medicines and Healthcare products Regulatory Agency UK final verified 2026-07-30 link (opens in new tab) · retrieved
MHRA AI Airlock Medicines and Healthcare products Regulatory Agency UK not yet verified frozen not a document 2026-07-31 link (opens in new tab) · retrieved
NIST agent standards US National Institute of Standards and Technology US not yet verified frozen not a document link (opens in new tab)
NIST AI RMF US National Institute of Standards and Technology International not yet verified checked — no status stated 2026-08-01 link (opens in new tab) · retrieved
NIST AI RMF Playbook US National Institute of Standards and Technology US not yet verified frozen register states no status link (opens in new tab)
NIST CSF 2.0 US National Institute of Standards and Technology US final verified 2026-08-01 link (opens in new tab) · retrieved
NMPA National Medical Products Administration China final verified 2026-07-28 link (opens in new tab) · retrieved
PIC/S PI 041 Pharmaceutical Inspection Co-operation Scheme International final verified paywalled — progression tracked 2026-08-01 link (opens in new tab) · retrieved
PMDA AI Pharmaceuticals and Medical Devices Agency Japan not yet verified frozen listing only link (opens in new tab)
Swissmedic Swissmedic Switzerland not yet verified frozen listing only link (opens in new tab)
TGA SaMD Therapeutic Goods Administration Australia not yet verified frozen blocks automated requests link (opens in new tab)
WHO AI health World Health Organization International final tool-read 2026-07-30 link (opens in new tab) · retrieved
WHO computerised systems World Health Organization International not yet verified frozen listing only link (opens in new tab)

Last updated: