Översikt Medicintekniska produkter och medicintekniska produkter för in vitro-diagnostik spelar en avgörande roll för att rädda liv, genom att erbjuda… Nuvarande direktiv Följande direktiv om medicintekniska produkter gäller för närvarande i EU 1998: Europaparlamentets och rådets direktiv 98/79/EG... Nya förordningar EU har reviderat lagstiftningen om medicintekniska produkter och medicintekniska produkter för in vitro-diagnostik för att anpassa den till utvecklingen i branschen de senaste 20 åren. Avsikten ... Latest updates News announcement10 augusti 2022MDCG 2022-13 - Designation, re-assessment and notification of conformity assessment bodies and notified bodiesNews announcement5 augusti 2022Call for EU reference laboratories sent to Member StatesNews announcement13 juli 2022MDCG 2022-12 - Harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for IVDR)News announcement5 juli 2022Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications in accordance with Regulation (EU) 2017/746Visa alla Highlights News announcement5 augusti 2022Call for EU reference laboratories sent to Member StatesBenchmarks for high-risk diagnosticsNews announcement21 juni 2022Setting the scene for EU reference labs for high-risk diagnostics26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EUNews announcement24 maj 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devicesNews announcement26 maj 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devicesThe UDI Helpdesk helps economic operators in the implementation of the requirements introduced by the new systemGetting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities Events 07maj2021 Möten med samarbetspartner Webinar for Patients – Safe and performant Medical Devices for all Documents EventsPublications
News announcement10 augusti 2022MDCG 2022-13 - Designation, re-assessment and notification of conformity assessment bodies and notified bodies
News announcement13 juli 2022MDCG 2022-12 - Harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for IVDR)
News announcement5 juli 2022Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications in accordance with Regulation (EU) 2017/746
26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EU
News announcement24 maj 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices
News announcement26 maj 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices
The UDI Helpdesk helps economic operators in the implementation of the requirements introduced by the new system
Getting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities
07maj2021 Möten med samarbetspartner Webinar for Patients – Safe and performant Medical Devices for all
