Medical Device Regulation (MDR) | 合法醫療器材資訊網

FreseniusMedicalCareiscommittedtoensuringthatallourmedicaldevicesmeettheapplicableMDRrequirementsinaccordancewiththerespective ...

The European Database on Medical Devices (EUDAMED) is a database managed by the EU Commission for the storing of information about medical devices.

The aim of EUDAMED is to strengthen market surveillance by providing competent authorities with fast access to information on manufacturers, authorized representatives, medical devices, certificates and vigilance data, to share information on clinical investigation data, as well as to contribute to a uniform application of regulatory requirements, in particular in relation to registration requirements.​

All manufacturers and all medical devices to be placed on the EU market will be registered in EUDAMED. Manufacturers (like Fresenius Medical Care) have to ensure that all data provided to EUDAMED are correct and up-to-date. Data includes pr...