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This wiki is a structured reference database for regulatory documents in the medical devices, in vitro diagnostics, and pharmaceutical sectors. Each document is stored with standardized metadata (scope, validity status, region, official source) and linked to individual reference pages for key articles, annexes, and provisions.

The database currently covers regulations, directives, and guidelines in the MD, IVD, HM, GMP, PV, and NIS scopes. Cross-references between equivalent provisions in different regulations are maintained explicitly.

Structured queries are available on the Document Index. Use GxPlex Search for filter-based browsing, or Special:Ask for custom SMW queries.

All registered users can contribute. New pages require reviewer approval before becoming publicly visible.

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By category Medical Devices In Vitro Diagnostics Clinical Post-Market Surveillance Labelling Traceability

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Recent documents

	Document name	Scope	Region	Status
N.A. (STROBE)statement: guidelines for reporting observational studies Apr-2008	(STROBE)statement: guidelines for reporting observational studies	INS	N.A.	N.A.
EU 2011/C 172/01 - CT-3 11-Jun-2011	2011/C 172/01 - CT-3	G	EU	Current
USA 21 CFR Part 11 09-Apr-2025	21 CFR Part 11	G	USA	Current
USA 21 CFR Part 312 09-Apr-2025	21 CFR Part 312	HM	USA	Current
USA 21 CFR Part 314 09-Apr-2025	21 CFR Part 314	HM	USA	Current
USA 21 CFR Part 320 09-Apr-2025	21 CFR Part 320	HM	USA	Current
USA 21 CFR Part 50 09-Apr-2025	21 CFR Part 50	G	USA	Current
USA 21 CFR Part 54 09-Apr-2025	21 CFR Part 54	G	USA	Current
USA 21 CFR Part 56 09-Apr-2025	21 CFR Part 56	G	USA	Current
USA 21 CFR Part 809 06-May-2024	21 CFR Part 809	G	USA	Current
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