OverviewMedical devices and In Vitro Diagnostic medical devices (IVDs) have a fundamental role in saving lives by providing innovative healthcare solutions…DirectivesThe following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively...New RegulationsThe EU revised the laws governing medical devices and in vitro diagnostics to align with the developments of the sector over the last 20 years. Latest updates News announcement28 Márta 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 Márta 2023Regulation (EU) 2023/607 of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisionsNews announcement10 Márta 2023MDCG work in progress - Ongoing guidance documentsNews announcement14 Feabhra 2023MDCG 2023-3 - Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices - February 2023Féach na Highlights News announcement5 Lúnasa 2022Call for EU reference laboratories sent to Member StatesBenchmarks for high-risk diagnosticsNews announcement21 Meitheamh 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 Bealtaine 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devicesNews announcement26 Bealtaine 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 27Már2023Comhdhálacha agus cruinnithe mullaighDay 1: 27 March 2023 Joint IMDRF / Stakeholder (DITTA-GMTA) Workshop28Már2023Comhdhálacha agus cruinnithe mullaighDay 2: 28 March 2023 IMDRF Stakeholder Forum07Bea2021Cruinnithe comhpháirtíochtaWebinar for Patients – Safe and performant Medical Devices for all Documents EventsPublications
OverviewMedical devices and In Vitro Diagnostic medical devices (IVDs) have a fundamental role in saving lives by providing innovative healthcare solutions…
DirectivesThe following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively...
New RegulationsThe EU revised the laws governing medical devices and in vitro diagnostics to align with the developments of the sector over the last 20 years.
News announcement28 Márta 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 Márta 2023Regulation (EU) 2023/607 of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions
News announcement14 Feabhra 2023MDCG 2023-3 - Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices - February 2023
26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EU
News announcement24 Bealtaine 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices
News announcement26 Bealtaine 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
27Már2023Comhdhálacha agus cruinnithe mullaighDay 1: 27 March 2023 Joint IMDRF / Stakeholder (DITTA-GMTA) Workshop
07Bea2021Cruinnithe comhpháirtíochtaWebinar for Patients – Safe and performant Medical Devices for all
