Aperçu général Cette page rassemble des informations et des liens sur des questions pertinentes pour la mise en œuvre du règlement relatif aux dispositifs médicaux. Par conséquent, le... Organismes notifiés Un organisme notifié est une organisation désignée par un État membre de l’UE (ou par d’autres pays dans le cadre d’accords spécifiques) pour évaluer… Identifiant unique des dispositifs (IUD) L’identifiant unique des dispositifs (IUD) est un code numérique ou alphanumérique unique lié à un dispositif médical qui permet l'identification… RetraitementHealth institutions reprocessing single-use devicesNational rules on reprocessing of single-use devicesHarmonised standards Harmonised European standards under the medical devices Regulations are developed by CEN and Cenelec as European standardisation organisations, Latest updatesNews announcement | 17 mai 2022New publication of Harmonised standards under the medical devices RegulationsNews announcement | 23 mars 2022Update - Short overview of the information on the applications for designation as a notified bodyNews announcement | 4 octobre 2021The EUDAMED UDI/Devices and NBs & Certificates modules are open. Economic Operators and Notified Bodies can start entering data in EUDAMED on voluntary basisNews announcement | 3 septembre 2021The expert panel in the field of in vitro diagnostic medical devices now accepts submissions from notified bodies for the Performance Evaluation Consultation ProcedureTout afficher 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 publications | 12 juillet 2020Commission guidelines on Union-wide derogations for medical devicesGeneral publications | 26 juin 2020List of COVID-19 essential Medical Devices (MDs and IVDs) DocumentsPublications
News announcement | 17 mai 2022New publication of Harmonised standards under the medical devices Regulations
News announcement | 23 mars 2022Update - Short overview of the information on the applications for designation as a notified body
News announcement | 4 octobre 2021The EUDAMED UDI/Devices and NBs & Certificates modules are open. Economic Operators and Notified Bodies can start entering data in EUDAMED on voluntary basis
News announcement | 3 septembre 2021The expert panel in the field of in vitro diagnostic medical devices now accepts submissions from notified bodies for the Performance Evaluation Consultation Procedure
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 publications | 12 juillet 2020Commission guidelines on Union-wide derogations for medical devices
