This topic gathers information and links on issues that are relevant for the implementation of the Medical Devices Regulation (MDR). Therefore, the…
A notified body is an organisation designated by an EU Member State (or by other countries under specific agreements) to assess the conformity of…
The unique device identification (UDI) is a unique numeric or alphanumeric code related to a medical device. It allows for a clear and unambiguous…
Harmonised European standards under the medical devices Regulations are developed by CEN and Cenelec as European standardisation organisations,
