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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 pages for its key articles, annexes, and provisions, organized by topic.

The database currently covers regulations, directives, and guidelines in the MD, IVD, GMP, PV, and NIS scopes. Cross-references between equivalent provisions in different regulations are maintained explicitly, for example between MDR and IVDR requirements on post-market surveillance or UDI.

Structured queries are available on the Document Index and on each category page. Use Special:Ask for custom queries across any combination of scope, status, region, or topic.

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

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By scope Medical Devices (MD) In Vitro Diagnostics (IVD)

By topic Clinical Post-Market Surveillance Labelling Traceability

Current documents

	Name	Scope	Region
In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746	In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746	IVD	EU
TestPage MDR	Medical Device Regulation (EU) 2017/745	MD	EU

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