50 lines
2.2 KiB
Plaintext
50 lines
2.2 KiB
Plaintext
{{RegDocument
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| area_of_validity = EU
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| scope = MD
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| document_type = Regulation
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| name = Medical Device Regulation (EU) 2017/745
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| version = 2017/745, amended by 2023/607
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| source = https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745
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| language = EN, DE, FR (all EU official languages)
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| status = Current
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| restricted_access = No
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}}
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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.
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Full application started on 26 May 2021. The amendment 2023/607 introduced a phased transition period for legacy devices.
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== Key references ==
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{| class="wikitable" style="width:100%;"
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! Topic / Keyword(s) !! Category / Chapter !! Scope !! Linked document !! Description
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{{Reference
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| topic = Post-market surveillance, PMCF
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| category = Clinical
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| scope = MD
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| linked_document = [[MDR 2017/745 – Articles 83–86 & Annex XIV Part B: Post-Market Surveillance and PMCF]]
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| description = Articles 83–86 define the mandatory PMS system; Annex XIV Part B specifies PMCF requirements.
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}}
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{{Reference
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| topic = Unique Device Identification, UDI, Traceability
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| category = Labelling
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| scope = MD
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| linked_document = [[MDR 2017/745 – Articles 27–29 & Annex VI: Unique Device Identification (UDI)]]
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| description = Articles 27–29 and Annex VI establish the UDI system. All devices must carry a UDI carrier on label and packaging.
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}}
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{{Reference
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| topic = Clinical evaluation, Clinical evidence
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| category = Clinical
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| scope = MD
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| linked_document =
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| description = Article 61 and Annex XIV Part A define the clinical evaluation process and documentation requirements (CER). ''Page not yet created.''
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}}
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|}
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== Related documents ==
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* [[In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746]] – Parallel regulation for IVDs
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[[Category:Medical Devices]]
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[[Category:EU Regulation]]
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