Prezentare generală Această pagină conține informații și linkuri relevante pentru punerea în aplicare a Regulamentului privind dispozitivele medicale (MDR). ... Organisme notificate Un organism notificat este o organizație desemnată de un stat membru al UE (sau de alte țări, în temeiul unor acorduri specifice) să evalueze… Identificatorul unic al unui dispozitiv – UDI Prin sistemul de identificare unică a dispozitivului (UDI), fiecare dispozitiv medical primește un cod numeric sau alfanumeric unic. Astfel, se… ReprelucrareaHealth 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 martie 2022Update - Short overview of the information on the applications for designation as a notified bodyNews announcement | 4 octombrie 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 septembrie 2021The expert panel in the field of in vitro diagnostic medical devices now accepts submissions from notified bodies for the Performance Evaluation Consultation ProcedureVedeți tot 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 iulie 2020Commission guidelines on Union-wide derogations for medical devicesGeneral publications | 26 iunie 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 martie 2022Update - Short overview of the information on the applications for designation as a notified body
News announcement | 4 octombrie 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 septembrie 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 iulie 2020Commission guidelines on Union-wide derogations for medical devices
