https://gxplex.org/index.php?action=history&feed=atom&title=In_Vitro_Diagnostic_Medical_Devices_Regulation_%28EU%29_2017%2F746 2026-10-07T13:13:30Z Revision history for this page on the wiki MediaWiki 1.43.8 https://gxplex.org/index.php?title=In_Vitro_Diagnostic_Medical_Devices_Regulation_(EU)_2017/746&diff=8931&oldid=prev 2026-06-29T13:00:50Z

<p>style: remove width:100% from wikitable</p> <p><b>New page</b></p><div>{{RegDocument<br /> | area_of_validity = EU<br /> | scope = IVD<br /> | document_type = Regulation<br /> | name = In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746<br /> | version = 2017/746, amended by 2022/1107<br /> | source = https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746<br /> | language = EN, DE, FR (all EU official languages)<br /> | status = Current<br /> | restricted_access = No<br /> }}<br /> <br /> The In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746 replaces the former IVD Directive (IVDD 98/79/EC). It introduces a significantly stricter framework for in vitro diagnostic medical devices, including reclassification of the majority of IVDs into higher risk classes requiring Notified Body involvement.<br /> <br /> Full application started on 26 May 2022. The amendment 2022/1107 introduced a phased transition for legacy devices based on device class and Notified Body capacity.<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 performance follow-up, PMPF<br /> | category = Clinical<br /> | scope = IVD<br /> | linked_document = [[IVDR (EU) 2017/746 – Articles 78–81 &amp; Annex XIII Part B: Post-Market Performance Follow-Up]]<br /> | description = Articles 78–81 and Annex XIII Part B define the mandatory post-market performance follow-up (PMPF) system, equivalent to PMCF under MDR.<br /> }}<br /> {{Reference<br /> | topic = Unique Device Identification, UDI, Traceability<br /> | category = Labelling<br /> | scope = IVD<br /> | linked_document = [[IVDR (EU) 2017/746 – Articles 24–26 &amp; Annex VI: UDI]]<br /> | description = Articles 24–26 and Annex VI establish the UDI system for IVDs, aligned with the MDR UDI framework.<br /> }}<br /> {{Reference<br /> | topic = Performance evaluation, Scientific validity<br /> | category = Clinical<br /> | scope = IVD<br /> | linked_document = [[IVDR (EU) 2017/746 – Article 56 &amp; Annex XIII Part A: Performance Evaluation]]<br /> | description = Article 56 and Annex XIII Part A define performance evaluation requirements, including analytical performance, clinical performance, and scientific validity.<br /> }}<br /> |}<br /> <br /> [[Category:In Vitro Diagnostics]]<br /> [[Category:EU Regulation]]</div>

Gxplex admin