Medical Delta professor Rob Nelissen (LUMC, TU Delft) has been appointed as chair of the European medical devices expert panel in the field of orthopedics, traumatology, rehabilitation and rheumatology. Among other things, the panel provides independent advice to DG Sante (Directorate-General for Health and Food Safety) of the European Commission on innovative class III implants, such as hip implants or stents for coronary arteries, that may enter the European market (CE certification).
The expert panels have been newly set up in the context of the MDR (Medical Device Regulation) which will be implemented by 26 May 2021. The expert panel of which Nelissen will be chairman, consists of 24 members.
In addition to Orthopedic Surgeon and Professor of Orthopedics, Nelissen also is Scientific Leader of the scientific program Medical Delta: Improving Mobility with Technology.
The MDR intends to ensure that medical devices entering the European market are safe and effective, while supporting innovation. The MDR contains stricter controls for high-risk medical devices. This is done through an extensive pre-market check process, tighter regulation of clinical evidence and more transparency. The newly established expert panels are scientific bodies that, together with expert laboratories and EU reference laboratories, provide scientific and technical advice to the European Commission, Member States, notified bodies and manufacturers. They also contribute to guidelines and other relevant documents and identify new problems that arise around medical devices.
Read more about the Medical Devices expert panels here.