Overview The EU has revised the legal framework of 3 directives to reflect progress over the last 20 years. Getting readyManufacturer IVDManufacturers MDManufacturers of devices without an intended medical purposeHealthcare professionals and health institutionsThe procurement of MDs and IVDsAuthorised Representatives, Importers and DistributorsCompetent authorities in non-EU/EEA countriesGuidance The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations.These are… Latest updatesNews announcement5 Lúnasa 2022Call for EU reference laboratories sent to Member StatesNews announcement5 Iúil 2022Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications in accordance with Regulation (EU) 2017/746News announcement21 Meitheamh 2022Setting the scene for EU reference labs for high-risk diagnosticsNews announcement24 Bealtaine 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devicesFéach na HighlightsNews 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 announcement26 Bealtaine 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devicesGeneral publications10 Iúil 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 Events07May2021 Cruinnithe comhpháirtíochta Webinar for Patients – Safe and performant Medical Devices for all DocumentsEventsPublications
News announcement5 Iúil 2022Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications in accordance with Regulation (EU) 2017/746
News announcement24 Bealtaine 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices
26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EU
News announcement26 Bealtaine 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices
General publications10 Iúil 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
07May2021 Cruinnithe comhpháirtíochta Webinar for Patients – Safe and performant Medical Devices for all
