OversigtEU har revideret de lovgivningsmæssige rammer for tre direktiver, så de afspejler udviklingen gennem de seneste 20 år.Bliv klarManufacturer IVDThe procurement of MDs and IVDsAuthorised Representatives, Importers and DistributorsCompetent authorities in non-EU/EEA countriesVejledningerEuropa-Kommissionen stiller en række vejledninger til rådighed som hjælp til interessenterne ved gennemførelse af forordningen om medicinsk udstyr… Latest updatesNews announcement28 Marts 2023Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 - Extension of the MDR transitional period and removal of the “sell off” periodsNews announcement20 Marts 2023Regulation (EU) 2023/607 of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisionsNews announcement7 Marts 2023Commissioner Kyriakides welcomes Council vote on the Medical Device Regulation extensionNews 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 HighlightsNews 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 announcement26 Maj 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devicesGeneral publications10 Juli 2020State of play of Joint implementation Plan on actions considered necessary to ensure the sound functioning of the new framework for medical devices under the MDRThe UDI Helpdesk is live. It helps the economic operators in the implementation of the requirements introduced by the new UDI systemGetting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities Events28Mar.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 DocumentsEventsPublications
OversigtEU har revideret de lovgivningsmæssige rammer for tre direktiver, så de afspejler udviklingen gennem de seneste 20 år.
Bliv klarManufacturer IVDThe procurement of MDs and IVDsAuthorised Representatives, Importers and DistributorsCompetent authorities in non-EU/EEA countries
VejledningerEuropa-Kommissionen stiller en række vejledninger til rådighed som hjælp til interessenterne ved gennemførelse af forordningen om medicinsk udstyr…
News announcement28 Marts 2023Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 - Extension of the MDR transitional period and removal of the “sell off” periods
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 announcement7 Marts 2023Commissioner Kyriakides welcomes Council vote on the Medical Device Regulation extension
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 announcement26 Maj 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices
General publications10 Juli 2020State of play of Joint implementation Plan on actions considered necessary to ensure the sound functioning of the new framework for medical devices under the MDR
The UDI Helpdesk is live. It helps the economic operators in the implementation of the requirements introduced by the new UDI 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
