Clinical investigations and performance studies are critical in ensuring the safety and performance of medical devices and in vitro diagnostic, medical devices.
Member States, supported by the European Commission, are pleased to announce the launch of a pilot coordinated assessment of clinical investigations and performance studies across multiple Member States.
There are a number of guidance documents endorsed by the Medical Device Coordination Group to assist stakeholders with the implementation of the medical device Regulations, including Regulation (EU) 2017/746.
