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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:
- 1. Screening Panel
- 2. Orthopaedics, traumatology, rehabilitation, rheumatology
- 3. Circulatory system
- 4. Neurology
- 5. Respiratory system, anaesthesiology, intensive care
- 6. Endocrinology and diabetes
- 7. General and plastic surgery and dentistry
- 8. Obstetrics and gynaecology, including reproductive medicine
- 9. Gastroenterology and hepatology
- 10. Nephrology and urology
- 11. Ophthalmology
- 12. In vitro diagnostic medical devices
