Overview The following new legislation will be applicable within the EU26 May 2021: Regulation (EU) 2017/745 on Medical Devices26 May 2022: Regulation (EU)… Getting readyManufacturers 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 announcement | 1 Aibreán 2022Update - Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)News announcement | 2 Márta 2022Handover of Experts Panels SecretariatNews announcement | 7 Feabhra 2022Updated - Joint implementation Plan on actions considered necessary to ensure the sound functioning of the new framework for medical devices under the IVDRNews announcement | 20 Nollaig 2021Progressive roll-out of the In Vitro Diagnostic Medical Devices RegulationFéach na HighlightsGeneral publications | 26 Bealtaine 2021Notice to stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devicesGeneral publications | 10 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 systemVideo recording of the Webinar for Patients – Safe and performant Medical Devices for all (7 May 2021)Getting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activitiesCommission Notice on notified bodies’ audits performed during Covid-19 exceptional circumstancesGeneral publications | 15 Iúil 2020Factsheet on MDR requirements for Transparency and Public InformationGeneral publications | 12 Iúil 2020Commission guidelines on Union-wide derogations for medical devices Events07May2021 Cruinnithe comhpháirtíochta Webinar for Patients – Safe and performant Medical Devices for all DocumentsEventsPublications
News announcement | 1 Aibreán 2022Update - Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
News announcement | 7 Feabhra 2022Updated - Joint implementation Plan on actions considered necessary to ensure the sound functioning of the new framework for medical devices under the IVDR
News announcement | 20 Nollaig 2021Progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation
General publications | 26 Bealtaine 2021Notice to stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices
General publications | 10 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
Video recording of the Webinar for Patients – Safe and performant Medical Devices for all (7 May 2021)
Getting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities
General publications | 15 Iúil 2020Factsheet on MDR requirements for Transparency and Public Information
General publications | 12 Iúil 2020Commission guidelines on Union-wide derogations for medical devices
07May2021 Cruinnithe comhpháirtíochta Webinar for Patients – Safe and performant Medical Devices for all
