OverviewThis topic gathers information and links on issues that are relevant for the implementation of the Medical Devices Regulation (MDR). Therefore, the…Notified BodiesA notified body is an organisation designated by an EU Member State (or by other countries under specific agreements) to assess the conformity of…Unique Device Identifier - UDIThe unique device identification (UDI) is a unique numeric or alphanumeric code related to a medical device. It allows for a clear and unambiguous…ReprocessingHealth institutions reprocessing single-use devicesNational rules on reprocessing of single-use devicesHarmonised standardsHarmonised European standards under the medical devices Regulations are developed by CEN and Cenelec as European standardisation organisations, Latest updatesNews announcement26 Deireadh Fómhair 2022Notified bodies survey on certifications and applicationsNews announcement7 Meán Fómhair 2022Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (September 2022)News announcement17 Bealtaine 2022New publication of Harmonised standards under the medical devices RegulationsNews announcement23 Márta 2022Update - Short overview of the information on the applications for designation as a notified bodyFéach na MD Topics of Interest - HighlightsThe 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 activitiesCommission Notice on notified bodies’ audits performed during Covid-19 exceptional circumstancesGeneral publications12 Iúil 2020Commission guidelines on Union-wide derogations for medical devicesGeneral publications26 Meitheamh 2020List of COVID-19 essential Medical Devices (MDs and IVDs) DocumentsPublications
OverviewThis topic gathers information and links on issues that are relevant for the implementation of the Medical Devices Regulation (MDR). Therefore, the…
Notified BodiesA notified body is an organisation designated by an EU Member State (or by other countries under specific agreements) to assess the conformity of…
Unique Device Identifier - UDIThe unique device identification (UDI) is a unique numeric or alphanumeric code related to a medical device. It allows for a clear and unambiguous…
ReprocessingHealth institutions reprocessing single-use devicesNational rules on reprocessing of single-use devices
Harmonised standardsHarmonised European standards under the medical devices Regulations are developed by CEN and Cenelec as European standardisation organisations,
News announcement7 Meán Fómhair 2022Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (September 2022)
News announcement17 Bealtaine 2022New publication of Harmonised standards under the medical devices Regulations
News announcement23 Márta 2022Update - Short overview of the information on the applications for designation as a notified body
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
