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Expert panels

Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) require the establishment of scientific bodies, i.e. committees of experts, expert laboratories and laboratories Reference Reference (EURL), to provide scientific and technical advice to the European Commission, Member States, notified bodies and manufacturers.

Panel of experts

The first scientific body to be constituted are the panels of experts.
Expert panels have been designated by means of the Commission Implementing Decision (EU) 2019/1396 in relevant medical fields.

Medical Device Coordination Group - MDCG

The expert panels have the following tasks, depending on needs

providing an opinion on the notified bodies’ assessments of clinical evaluation of certain high-risk medical devices and the performance evaluation of certain in vitro diagnostic medical devices
providing advice to the Medical Device Coordination Group (MDCG) and the European Commission concerning safety and performance of medical devices and in vitro diagnostic medical devices
providing advice to manufacturers on their clinical development strategy and proposals for clinical investigations
providing advice to EU countries, manufacturers and notified bodies on various scientific and technical matters
contributing to the development and maintenance of relevant guidance documents, common specifications and international standards
providing opinions in response to consultations from manufacturers, EU countries and notified bodies

Experts are appointed for a term of three years, with the possibility of renewal. During this time, they are part of one of the following 12 panels:

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