{{RegDocument
| area_of_validity  = EU
| scope             = MD
| document_type     = Regulation
| name              = Medical Device Regulation (EU) 2017/745
| version           = 2017/745, amended by 2023/607
| source            = https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745
| language          = 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 ==

{| class="wikitable" style="width:100%;"
! Topic / Keyword(s) !! Category / Chapter !! Scope !! Linked document !! Description
{{Reference
| topic           = Post-market surveillance, PMCF
| category        = Clinical
| scope           = MD
| linked_document = [[MDR 2017/745 – Articles 83–86 & Annex XIV Part B: Post-Market Surveillance and PMCF]]
| description     = Articles 83–86 define the mandatory PMS system; Annex XIV Part B specifies PMCF requirements.
}}
{{Reference
| topic           = Unique Device Identification, UDI, Traceability
| category        = Labelling
| scope           = MD
| linked_document = [[MDR 2017/745 – Articles 27–29 & Annex VI: Unique Device Identification (UDI)]]
| description     = Articles 27–29 and Annex VI establish the UDI system. All devices must carry a UDI carrier on label and packaging.
}}
{{Reference
| topic           = Clinical evaluation, Clinical evidence
| category        = Clinical
| scope           = MD
| linked_document =
| description     = 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

[[Category:Medical Devices]]
[[Category:EU Regulation]]
