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All regulatory documents currently in this wiki. Click any column header to sort.

	Document	Scope	Region	Type	Status	Language	Restricted
In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746	In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746	IVD	EU	Regulation	Current	EN, DE, FR (all EU official languages)	No
TestPage MDR	Medical Device Regulation (EU) 2017/745	MD	EU	Regulation	Current	EN, DE, FR (all EU official languages)	No

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Topic	Description
Medical Devices	Regulatory documents and references under MDR (EU 2017/745)
In Vitro Diagnostics	Regulatory documents and references under IVDR (EU 2017/746)
EU Regulation	Core EU regulatory frameworks covering medical devices and IVDs
Clinical	Clinical evaluation, clinical performance studies, PMCF, and PMPF
Labelling	Labelling requirements, UDI carriers, and packaging obligations
Post-Market Surveillance	PMS plans, PMCF, PMPF, and periodic safety update reports
Performance Evaluation	Performance evaluation plans, reports, and PMPF for IVD devices
Traceability	UDI systems and device identification obligations under MDR and IVDR

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Property	Example values
Area of validity	EU, USA, Global, DE
Scope	MD, IVD, GMP, GEP, NIS, PV, IMP
Document type	Regulation, Directive, Guideline, Scientific article, Treaty
Status	Current, Draft, Final not promulgated, Superseded
Language	EN, DE, FR
Restricted access	Yes, No

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