ÖversiktMedicintekniska produkter och medicintekniska produkter för in vitro-diagnostik spelar en avgörande roll för att rädda liv, genom att erbjuda…Nuvarande direktivFöljande direktiv om medicintekniska produkter gäller för närvarande i EU 1998: Europaparlamentets och rådets direktiv 98/79/EG...Nya förordningarEU 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. Latest updates News announcement6 december 2023Designation of EU reference laboratories for high-risk in vitro diagnostic medical devicesNews announcement6 december 2023Commission Implementing Regulation (EU) 2023/2713 of 5 December 2023 designating European Union reference laboratories in the field of in vitro diagnostic medical devicesNews announcement1 december 2023Study supporting the monitoring of availability of medical devices on the EU market - Surveys for MD and IVD manufacturers and authorised representativesNews announcement29 november 2023Update - Rev 1 - MDCG Position Paper: Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements - November 2023Visa 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 25-26sep2023Konferenser och toppmötenIMDRF Meeting 24th session - 25-26 September 2023 - Berlin, Germany28mar2023Konferenser och toppmötenDay 2: 28 March 2023 IMDRF Stakeholder Forum27mar2023Konferenser och toppmötenDay 1: 27 March 2023 Joint IMDRF / Stakeholder (DITTA-GMTA) Workshop07maj2021Möten med samarbetspartnerWebinar for Patients – Safe and performant Medical Devices for all Documents EventsPublications
ÖversiktMedicintekniska produkter och medicintekniska produkter för in vitro-diagnostik spelar en avgörande roll för att rädda liv, genom att erbjuda…
Nuvarande direktivFöljande direktiv om medicintekniska produkter gäller för närvarande i EU 1998: Europaparlamentets och rådets direktiv 98/79/EG...
Nya förordningarEU 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.
News announcement6 december 2023Designation of EU reference laboratories for high-risk in vitro diagnostic medical devices
News announcement6 december 2023Commission Implementing Regulation (EU) 2023/2713 of 5 December 2023 designating European Union reference laboratories in the field of in vitro diagnostic medical devices
News announcement1 december 2023Study supporting the monitoring of availability of medical devices on the EU market - Surveys for MD and IVD manufacturers and authorised representatives
News announcement29 november 2023Update - Rev 1 - MDCG Position Paper: Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements - November 2023
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
25-26sep2023Konferenser och toppmötenIMDRF Meeting 24th session - 25-26 September 2023 - Berlin, Germany
27mar2023Konferenser och toppmötenDay 1: 27 March 2023 Joint IMDRF / Stakeholder (DITTA-GMTA) Workshop
07maj2021Möten med samarbetspartnerWebinar for Patients – Safe and performant Medical Devices for all
