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 announcement31. august 2023MDR and IVDR Communication SurveyNews announcement23. august 2023Flowchart to assist in deciding whether or not a device is covered by the extended MDR transitional periodNews announcement18. juli 2023Rev. 1 - Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607News announcement30. juni 2023Add 1 - MDCG Position Paper on the application of Art.97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificateSe 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 25-26sep2023Konferencer og topmøderIMDRF Meeting 24th session - 25-26 September 2023 - Berlin, Germany28mar2023Konferencer og topmøderDay 2: 28 March 2023 IMDRF Stakeholder Forum27mar2023Konferencer 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 announcement23. august 2023Flowchart to assist in deciding whether or not a device is covered by the extended MDR transitional period
News announcement18. juli 2023Rev. 1 - Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607
News announcement30. juni 2023Add 1 - MDCG Position Paper on the application of Art.97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate
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
25-26sep2023Konferencer og topmøderIMDRF Meeting 24th session - 25-26 September 2023 - Berlin, Germany
