Sources
Every primary source used by this tracker, grouped by issuing authority. All are published documents, publicly available from the authority that issued them.
132 of 132 tracked instruments, each listed under the authority named in its own record. The sections are those recorded values, and one exists while a record names it — so the headings here carry no permanent link.
ASTM International
- ASTM E2363 — primary source (opens in new tab) store.astm.org · retrieved
- ASTM E2500 — primary source (opens in new tab) store.astm.org · retrieved
- ASTM E2537 — primary source (opens in new tab) astm.org
Agência Nacional de Vigilância Sanitária
- ANVISA — primary source (opens in new tab) gov.br
CEN/CENELEC
- CEN/CLC JTC 21 — primary source (opens in new tab) cencenelec.eu
CEN/CENELEC JTC 21
- prEN 18229-1 — primary source (opens in new tab) cencenelec.eu
- prEN 18229-2 — primary source (opens in new tab) cencenelec.eu
- prEN 18281 — primary source (opens in new tab) cencenelec.eu
- prEN 18282 — primary source (opens in new tab) cencenelec.eu
Cybersecurity and Infrastructure Security Agency
- CISA CPG 2.0 — primary source (opens in new tab) cisa.gov
European Commission
- EU GMP Annex 1 — primary source (opens in new tab) health.ec.europa.eu
- EU GMP Annex 10 — primary source (opens in new tab) health.ec.europa.eu
- EU GMP Annex 11 (draft) — primary source (opens in new tab) health.ec.europa.eu
- EU GMP Annex 11 — primary source (opens in new tab) health.ec.europa.eu · retrieved
- EU GMP Annex 12 — primary source (opens in new tab) health.ec.europa.eu
- EU GMP Annex 13 — primary source (opens in new tab) health.ec.europa.eu
- EU GMP Annex 14 — primary source (opens in new tab) health.ec.europa.eu · retrieved
- EU GMP Annex 15 — primary source (opens in new tab) health.ec.europa.eu
- EU GMP Annex 16 — primary source (opens in new tab) health.ec.europa.eu
- EU GMP Annex 17 — primary source (opens in new tab) health.ec.europa.eu
- EU GMP Annex 19 — primary source (opens in new tab) health.ec.europa.eu
- EU GMP Annex 2 — primary source (opens in new tab) health.ec.europa.eu
- EU GMP Annex 21 — primary source (opens in new tab) health.ec.europa.eu
- EU GMP Annex 22 — primary source (opens in new tab) health.ec.europa.eu
- EU GMP Annex 3 — primary source (opens in new tab) health.ec.europa.eu
- EU GMP Annex 6 — primary source (opens in new tab) health.ec.europa.eu
- EU GMP Annex 7 — primary source (opens in new tab) health.ec.europa.eu
- EU GMP Annex 8 — primary source (opens in new tab) health.ec.europa.eu
- EU GMP Annex 9 — primary source (opens in new tab) health.ec.europa.eu
- EU GMP Chapter 1 — primary source (opens in new tab) health.ec.europa.eu
- EU GMP Chapter 2 — primary source (opens in new tab) health.ec.europa.eu
- EU GMP Chapter 3 — primary source (opens in new tab) health.ec.europa.eu
- EU GMP Chapter 4 (draft) — primary source (opens in new tab) health.ec.europa.eu
- EU GMP Chapter 4 — primary source (opens in new tab) health.ec.europa.eu
- EU GMP Chapter 5 — primary source (opens in new tab) health.ec.europa.eu
- EU GMP Chapter 6 — primary source (opens in new tab) health.ec.europa.eu
- EU GMP Chapter 7 — primary source (opens in new tab) health.ec.europa.eu
- EU GMP Chapter 8 — primary source (opens in new tab) health.ec.europa.eu
- EU GMP Chapter 9 — primary source (opens in new tab) health.ec.europa.eu
European Medicines Agency
- EMA AI reflection paper — primary source (opens in new tab) ema.europa.eu · retrieved
- Annex 11 concept paper — primary source (opens in new tab) ema.europa.eu
- EMA CT computerised systems — primary source (opens in new tab) ema.europa.eu · retrieved
- EMA data quality framework — primary source (opens in new tab) ema.europa.eu · retrieved
- EMA work programme — primary source (opens in new tab) ema.europa.eu · retrieved
European Medicines Agency and Pharmaceutical Inspection Co-operation Scheme
- Annex 15 revision concept paper — primary source (opens in new tab) ema.europa.eu
- DI revision concept paper — primary source (opens in new tab) ema.europa.eu
European Parliament and Council
- EU AI Act — primary source (opens in new tab) eur-lex.europa.eu · retrieved
- EU Cyber Resilience Act — primary source (opens in new tab) eur-lex.europa.eu · retrieved
- EU Cybersecurity Act — primary source (opens in new tab) eur-lex.europa.eu · retrieved
- Regulation (EU) 2026/1744 — primary source (opens in new tab) eur-lex.europa.eu · retrieved
- EU IVDR — primary source (opens in new tab) eur-lex.europa.eu · retrieved
- EU Machinery Regulation — primary source (opens in new tab) eur-lex.europa.eu · retrieved
- EU MDR — primary source (opens in new tab) eur-lex.europa.eu · retrieved
- EU NIS2 Directive — primary source (opens in new tab) eur-lex.europa.eu · retrieved
Health Canada
- Health Canada ML — primary source (opens in new tab) canada.ca · retrieved
IEC
- IEC 81001-5-1 — primary source (opens in new tab) webstore.iec.ch
IEC / ISA
- IEC 62443 — primary source (opens in new tab) isa.org
ISO
- ISO 81001-1 — primary source (opens in new tab) iso.org
ISO/IEC
- IEC 62304 — primary source (opens in new tab) iso.org · retrieved
- ISO 13485 — primary source (opens in new tab) iso.org · retrieved
- ISO 14971 — primary source (opens in new tab) iso.org · retrieved
- ISO/IEC 22989 — primary source (opens in new tab) iso.org · retrieved
- ISO/IEC 23894 — primary source (opens in new tab) iso.org · retrieved
- ISO/IEC 24028 — primary source (opens in new tab) iso.org · retrieved
- ISO/IEC 27001 — primary source (opens in new tab) iso.org · retrieved
- ISO/IEC 27002 — primary source (opens in new tab) iso.org · retrieved
- ISO/IEC 27017:2026 — primary source (opens in new tab) iso.org · retrieved
- ISO/IEC 27017 — primary source (opens in new tab) iso.org · retrieved
- ISO/IEC 27018:2025 — primary source (opens in new tab) iso.org · retrieved
- ISO/IEC 27018 — primary source (opens in new tab) iso.org · retrieved
- ISO/IEC 38507 — primary source (opens in new tab) iso.org · retrieved
- ISO/IEC 42001 — primary source (opens in new tab) iso.org · retrieved
- ISO/IEC 42005 — primary source (opens in new tab) iso.org · retrieved
- ISO/IEC 5259 — primary source (opens in new tab) iso.org · retrieved
- ISO/IEC SC 42 — primary source (opens in new tab) iso.org · retrieved
ISPE
- GAMP AI Guide — primary source (opens in new tab) ispe.org
- GAMP 5 2nd Ed — primary source (opens in new tab) ispe.org
Institute of Electrical and Electronics Engineers
- IEEE 7000 — primary source (opens in new tab) standards.ieee.org · retrieved
International Council for Harmonisation
- ICH E6(R3) — primary source (opens in new tab) ich.org · retrieved
- ICH Q12 — primary source (opens in new tab) ich.org · retrieved
- ICH Q13 — primary source (opens in new tab) ich.org · retrieved
- ICH Q14 — primary source (opens in new tab) ich.org · retrieved
- ICH Q2(R2) — primary source (opens in new tab) ich.org · retrieved
- ICH Q9(R1) — primary source (opens in new tab) ich.org · retrieved
International Medical Device Regulators Forum
- IMDRF AI/ML WG — primary source (opens in new tab) imdrf.org
- IMDRF SaMD — primary source (opens in new tab) imdrf.org
International Society for Pharmaceutical Engineering
- ISPE GAMP RDI — primary source (opens in new tab) ispe.org
- ISPE Pharma 4.0 — primary source (opens in new tab) ispe.org
Medicines and Healthcare products Regulatory Agency
- MHRA AI Airlock — primary source (opens in new tab) gov.uk · retrieved
- MHRA AI — primary source (opens in new tab) gov.uk · retrieved
- MHRA data integrity — primary source (opens in new tab) gov.uk
National Institute of Standards and Technology
- NISTIR 8183 — primary source (opens in new tab) csrc.nist.gov
National Medical Products Administration
- NMPA portal — primary source (opens in new tab) english.nmpa.gov.cn · retrieved
Parenteral Drug Association
- PDA TR 80 — primary source (opens in new tab) pda.org
Pharmaceutical Inspection Co-operation Scheme
- PIC/S GMP Guide — primary source (opens in new tab) picscheme.org
- PIC/S Annex 11 — primary source (opens in new tab) picscheme.org
- PIC/S PI 011 — primary source (opens in new tab) picscheme.org
- PIC/S PI 041 — primary source (opens in new tab) picscheme.org · retrieved
Pharmaceuticals and Medical Devices Agency
- PMDA AI — primary source (opens in new tab) pmda.go.jp
Swissmedic
- Swissmedic — primary source (opens in new tab) swissmedic.ch
Therapeutic Goods Administration
- TGA SaMD — primary source (opens in new tab) tga.gov.au
US Food and Drug Administration
- FDA AI guidance — primary source (opens in new tab) fda.gov · retrieved
- FDA AI device list — primary source (opens in new tab) fda.gov
- FDA CDRH AI/ML — primary source (opens in new tab) fda.gov · retrieved
- FDA clinical decision support — primary source (opens in new tab) fda.gov · retrieved
- FDA CSA — primary source (opens in new tab) fda.gov · retrieved
- FDA data integrity — primary source (opens in new tab) fda.gov · retrieved
- FDA device cybersecurity (2026) — primary source (opens in new tab) fda.gov · retrieved
- FDA device cybersecurity — primary source (opens in new tab) fda.gov
- FDA electronic systems (clinical) — primary source (opens in new tab) fda.gov · retrieved
- FDA ETP — primary source (opens in new tab) fda.gov
- FDA GMLP guiding principles — primary source (opens in new tab) fda.gov
- FDA guidance agenda — primary source (opens in new tab) fda.gov
- FDA Part 11 scope — primary source (opens in new tab) fda.gov · retrieved
- FDA PCCP — primary source (opens in new tab) fda.gov · retrieved
- FDA postmarket cybersecurity — primary source (opens in new tab) fda.gov · retrieved
- FDA process analytical framework — primary source (opens in new tab) fda.gov
- FDA software validation — primary source (opens in new tab) fda.gov
- 21 CFR Part 11 — primary source (opens in new tab) ecfr.gov · retrieved
- 21 CFR Part 211 — primary source (opens in new tab) ecfr.gov · retrieved
- 21 CFR Part 820 (QMSR) — primary source (opens in new tab) ecfr.gov
US Food and Drug Administration and European Medicines Agency
US National Institute of Standards and Technology
- NIST agent standards — primary source (opens in new tab) nist.gov
- NIST AI 600-1 — primary source (opens in new tab) nvlpubs.nist.gov
- NIST AI RMF Playbook — primary source (opens in new tab) airc.nist.gov
- NIST AI RMF — primary source (opens in new tab) nist.gov · retrieved
- NIST CSF 2.0 — primary source (opens in new tab) csrc.nist.gov · retrieved · secondary (opens in new tab)
- NIST SP 800-82 — primary source (opens in new tab) csrc.nist.gov · retrieved
World Health Organization
- WHO AI health — primary source (opens in new tab) who.int
- WHO data management — primary source (opens in new tab) iris.who.int
- WHO computerised systems — primary source (opens in new tab) who.int
- WHO data integrity guideline — primary source (opens in new tab) iris.who.int · secondary (opens in new tab)
Whether a read has been attempted against each declared signal source, and what it returned, is on the observatory.
Curated stacks of these sources, each with the rule that selects it, are on bundles. What this record holds and does not, by domain and authority, is on coverage. What was added when, and the limb of the inclusion rule that admitted it, is on recent additions. Every authority these entries name, with its count, is on authorities. Where two official surfaces state different things about one entry, both are quoted on conflicting signals — a finding, and never a resolution between them.
Last updated: