OverblikFor at kunne redde liv er det vigtigt, at man har adgang til medicinsk udstyr, herunder medicinsk udstyr til in vitro-diagnostik (IVD), og kan…DirektiverFølgende direktiver om medicinsk udstyr er i øjeblikket gældende i EU 1998: Europa-Parlamentets og Rådets direktiv 98/79/EF...Nye forordningerEU har taget lovgivningen vedrørende medicinsk udstyr og medicinsk udstyr til in vitro-diagnostik op til revision for at afstemme den med udviklingen i sektoren i de seneste 20 år. Latest updates News announcement20 Marts 2023Regulation (EU) 2023/607 of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisionsNews announcement10 Marts 2023MDCG work in progress - Ongoing guidance documentsNews announcement14 Februar 2023MDCG 2023-3 - Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices - February 2023News announcement10 Februar 2023Update - MDCG 2020-16 Rev.2 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 - February 2023Se alle Highlights News announcement5 August 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 28Mar.2023Konferencer og topmøderDay 2: 28 March 2023 IMDRF Stakeholder Forum27Mar.2023Konferencer og topmøderDay 1: 27 March 2023 Joint IMDRF / Stakeholder (DITTA-GMTA) Workshop07Maj2021PartnermøderWebinar for Patients – Safe and performant Medical Devices for all Documents EventsPublications
OverblikFor at kunne redde liv er det vigtigt, at man har adgang til medicinsk udstyr, herunder medicinsk udstyr til in vitro-diagnostik (IVD), og kan…
DirektiverFølgende direktiver om medicinsk udstyr er i øjeblikket gældende i EU 1998: Europa-Parlamentets og Rådets direktiv 98/79/EF...
Nye forordningerEU har taget lovgivningen vedrørende medicinsk udstyr og medicinsk udstyr til in vitro-diagnostik op til revision for at afstemme den med udviklingen i sektoren i de seneste 20 år.
News announcement20 Marts 2023Regulation (EU) 2023/607 of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions
News announcement14 Februar 2023MDCG 2023-3 - Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices - February 2023
News announcement10 Februar 2023Update - MDCG 2020-16 Rev.2 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 - February 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
27Mar.2023Konferencer og topmøderDay 1: 27 March 2023 Joint IMDRF / Stakeholder (DITTA-GMTA) Workshop
