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Document Information
Area of validity	EU
Scope(s)	MD
Document type	Regulation
Document name	Medical Device Regulation (EU) 2017/745
Version / Revision	2017/745, amended by 2023/607
Official source	Official link
Language(s)	EN, DE, FR (all EU official languages)
Status	Current
Restricted access	No

The Medical Device Regulation (MDR) 2017/745 replaces the former Medical Device Directive (MDD 93/42/EEC) and the Active Implantable Medical Device Directive (AIMDD 90/385/EEC). It establishes a uniform regulatory framework for medical devices across EU member states, with a strong focus on clinical evidence, post-market surveillance, and traceability.

Full application started on 26 May 2021. The amendment 2023/607 introduced a phased transition period for legacy devices.

Key references

Topic / Keyword(s)	Category / Chapter	Scope	Linked document	Description
Post-market surveillance, PMCF	Clinical	MD	MDR 2017/745 – Articles 83–86 & Annex XIV Part B: Post-Market Surveillance and PMCF	Articles 83–86 define the mandatory PMS system; Annex XIV Part B specifies PMCF requirements.
Unique Device Identification, UDI, Traceability	Labelling	MD	MDR 2017/745 – Articles 27–29 & Annex VI: Unique Device Identification (UDI)	Articles 27–29 and Annex VI establish the UDI system. All devices must carry a UDI carrier on label and packaging.
Clinical evaluation, Clinical evidence	Clinical	MD		Article 61 and Annex XIV Part A define the clinical evaluation process and documentation requirements (CER). Page not yet created.

Related documents

• In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 – Parallel regulation for IVDs

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