2019年 9月 16日
The European Commission has clarified its designation process for appointing expert panels to support regulators, Notified Bodies and other entities meet requirements and obligations of the Medical Devices Regulation (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR).
According to a recent implementing decision from the Commission, expert panels are intended to provide scientific, clinical and technical support to regulators, European Union member state governments, Notified Bodies and device manufacturers related to either enforcement of or compliance to MDR and IVDR mandates.
(The MDR and IVDR will require Notified Bodies to utilize expert panels, for example, for clinical evaluations of high-risk medical devices as well as performance evaluations for some IVDs.)
European Commissioners and the Medical Device Coordination Group (MDCG) have identified 11 key areas in need of expert panel support, including orthopedics, neurology, circulatory and respiratory systems, endocrinology, obstetrics and gynecology, and IVD devices. However, the Commission notes in its implementing decision that these areas as well as lists of designated expert panels may change on an as-needed basis as effects of the new Regulations become more apparent, or as new scientific and/or clinical needs become apparent.
The implementing decision establishes qualifications for expert panelist appointments, compensation and conflict-of-interest baselines, and confidentiality and transparency requirements. Medical device and IVD manufacturers planning to obtain or maintain CE Marking under the MDR and IVDR should be aware of the role expert panels will play in affecting certifications for their products.