https://gxplex.org/index.php?action=history&feed=atom&title=TestPage_MDR 2026-10-07T12:14:09Z Revision history for this page on the wiki MediaWiki 1.43.8 https://gxplex.org/index.php?title=TestPage_MDR&diff=8930&oldid=prev 2026-06-29T13:00:49Z

<p>style: remove width:100% from wikitable</p> <p><b>New page</b></p><div>{{RegDocument<br /> | area_of_validity = EU<br /> | scope = MD<br /> | document_type = Regulation<br /> | name = Medical Device Regulation (EU) 2017/745<br /> | version = 2017/745, amended by 2023/607<br /> | source = https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745<br /> | language = EN, DE, FR (all EU official languages)<br /> | status = Current<br /> | restricted_access = No<br /> }}<br /> <br /> 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.<br /> <br /> Full application started on 26 May 2021. The amendment 2023/607 introduced a phased transition period for legacy devices.<br /> <br /> == Key references ==<br /> <br /> {| class=&quot;wikitable&quot;<br /> ! Topic / Keyword(s) !! Category / Chapter !! Scope !! Linked document !! Description<br /> {{Reference<br /> | topic = Post-market surveillance, PMCF<br /> | category = Clinical<br /> | scope = MD<br /> | linked_document = [[MDR 2017/745 – Articles 83–86 &amp; Annex XIV Part B: Post-Market Surveillance and PMCF]]<br /> | description = Articles 83–86 define the mandatory PMS system; Annex XIV Part B specifies PMCF requirements.<br /> }}<br /> {{Reference<br /> | topic = Unique Device Identification, UDI, Traceability<br /> | category = Labelling<br /> | scope = MD<br /> | linked_document = [[MDR 2017/745 – Articles 27–29 &amp; Annex VI: Unique Device Identification (UDI)]]<br /> | description = Articles 27–29 and Annex VI establish the UDI system. All devices must carry a UDI carrier on label and packaging.<br /> }}<br /> {{Reference<br /> | topic = Clinical evaluation, Clinical evidence<br /> | category = Clinical<br /> | scope = MD<br /> | linked_document =<br /> | description = Article 61 and Annex XIV Part A define the clinical evaluation process and documentation requirements (CER). &#039;&#039;Page not yet created.&#039;&#039;<br /> }}<br /> |}<br /> <br /> == Related documents ==<br /> <br /> * [[In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746]] – Parallel regulation for IVDs<br /> <br /> [[Category:Medical Devices]]<br /> [[Category:EU Regulation]]</div>

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