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 devicesManufacturers MDManufacturers of devices without an intended medical purposeHealthcare professionals and health institutionsNational 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 announcement13 January 2023Update - Coverage of designation codes by MDR/IVDR notified bodies - January 2023News announcement15 December 2022Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 - Version2 - December 2022 News announcement26 October 2022Notified bodies survey on certifications and applicationsNews announcement7 September 2022Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (September 2022)See all 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 July 2020Commission guidelines on Union-wide derogations for medical devicesGeneral publications26 June 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 devicesManufacturers MDManufacturers of devices without an intended medical purposeHealthcare professionals and health institutionsNational 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 announcement13 January 2023Update - Coverage of designation codes by MDR/IVDR notified bodies - January 2023
News announcement15 December 2022Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 - Version2 - December 2022
News announcement7 September 2022Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (September 2022)
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
