The Medical Device Coordination Group (MDCG) has primarily a coordinating and advisory function within the European Union. It is not authorised to make decisions, but advises the EU Commission on various matters, such as:
- Drawing up common specifications
- Determining details of the notification system
- Deciding on the inclusion of a product in the scope of the regulation.
The MDCG is also consulted by the Commission on the designation of technical laboratories or expert panels. Similarly, its opinions and recommendations are considered in the appointment of advisors to panels or inclusion in a central register.
Further tasks of the MDCG include, among others, the preparation of a market surveillance programme to be observed by the competent authorities. In addition, the MDCG can request scientific opinions on the safety and performance of a product from expert panels if there are justified concerns.
The MDCG thus plays an important role in coordinating and supporting the implementation of medical device legislation in the EU and helps to ensure a high level of safety and quality of medical devices.
