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 devicesManufacturers MDManufacturers of devices without an intended medical purposeHealthcare professionals and health institutionsHarmonised standardsHarmonised European standards under the medical devices Regulations are developed by CEN and Cenelec as European standardisation organisations, Combined studies Interface between the Regulations on clinical trials of medicinal products, medical devices and in vitro diagnostics Latest updatesNews announcement10 April 2024A Study and dashboard on reprocessing and reuse of single-use-devices in the EU1 min readNews announcement13 March 2024Updated document - Notified Bodies Survey on certifications and applications (MDR/IVDR) (Survey results with data status 11 March 2023)1 min readNews announcement11 March 2024New publication of Harmonised standards under the medical devices Regulations - March 20241 min readNews announcement9 January 2024Monitoring of availability of medical devices on the EU market1 min readSee all MD Topics of Interest - HighlightsNews announcement10 April 2024A Study and dashboard on reprocessing and reuse of single-use-devices in the EU1 min readStudy supporting the monitoring of availability of medical devices on the EU marketThe 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 devices1 min readGeneral publications26 June 2020List of COVID-19 essential Medical Devices (MDs and IVDs)1 min read 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 devicesManufacturers MDManufacturers of devices without an intended medical purposeHealthcare professionals and health institutions
Harmonised standardsHarmonised European standards under the medical devices Regulations are developed by CEN and Cenelec as European standardisation organisations,
Combined studies Interface between the Regulations on clinical trials of medicinal products, medical devices and in vitro diagnostics
News announcement10 April 2024A Study and dashboard on reprocessing and reuse of single-use-devices in the EU1 min read
News announcement13 March 2024Updated document - Notified Bodies Survey on certifications and applications (MDR/IVDR) (Survey results with data status 11 March 2023)1 min read
News announcement11 March 2024New publication of Harmonised standards under the medical devices Regulations - March 20241 min read
News announcement9 January 2024Monitoring of availability of medical devices on the EU market1 min read
News announcement10 April 2024A Study and dashboard on reprocessing and reuse of single-use-devices in the EU1 min read
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
General publications12 July 2020Commission guidelines on Union-wide derogations for medical devices1 min read
