Subject (as stated): artificial intelligence
13 of 86 tracked instruments.
This is a projection of the tracker, not a separate dataset. Its canonical URL is the tracker.
Status unknown 1 frozen 3 draft 2 final 6 in-force 1
Ordered by the lifecycle the values themselves name.
Subject (as stated) no self-stated subject 28 artificial intelligence 13 (active — select again to clear) software 9 medical devices 7 security 7 computerised systems 5 manufacturing 5 risk management 4
+15 more
data integrity 3 information security 3 quality management 3 trustworthiness 3 validation 3 clinical 2 cybersecurity 2 electronic records 2 electronic signatures 2 good manufacturing practice 2 machine learning 2 computer software 1 data quality 1 governance 1 in vitro diagnostic 1Values 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 7 consensus standard 3 authority guidance 2 legal act 1
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 13 of 86 instruments. Clear all filters
| 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) |
| EMA AI reflection paper | European Medicines Agency | EU | final check unrecorded | 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 GMP Annex 22 | European Commission | EU | not yet verified awaiting | — | — | 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 |
| GAMP AI Guide | ISPE | International | not yet verified frozen paywalled — progression tracked | — | — | link (opens in new tab) |
| IMDRF AI/ML WG | International Medical Device Regulators Forum | International | not yet verified frozen blocks automated requests | — | — | link (opens in new tab) |
| ISO/IEC 22989 | ISO/IEC | International | final verified | 2026-07-29 | — | link (opens in new tab) · retrieved |
| ISO/IEC 24028 | ISO/IEC | International | final verified | 2026-07-29 | — | link (opens in new tab) · retrieved |
| ISO/IEC 42001 | ISO/IEC | International | final verified | 2026-07-29 | — | link (opens in new tab) · retrieved |
| NMPA | National Medical Products Administration | China | final verified | 2026-07-28 | — | link (opens in new tab) · retrieved |
| WHO AI health | World Health Organization | International | final tool-read | 2026-07-30 | — | link (opens in new tab) · retrieved |
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