The European Commission published details this week on the expert panels that will provide advice about medical devices to groups including notified bodies.
Under the incoming EU Medical Device Regulation, notified bodies must consult with expert panels before clearing certain high-risk devices for marketing in the region. That gives expert panels a key, albeit advisory, role in enforcing the new, tougher market access rules.
The new publication by the Commission sets out the criteria people will need to meet to join an expert panel and the rules that will govern the advisory groups.
Working with the Medical Device Coordination Group, the Commission decided to create 11 expert panels covering a range of therapeutic areas such as neurology and ophthalmology. To fill the 11 panels, the Commission will put out a public call for experts detailing the selection criteria.
The Commission will not appoint experts who have "financial or other interests in the medical device industry or in a notified body or any other organization or sector, which could affect their independence, impartiality and objectivity." People interested in joining expert panels must declare any potential conflicts of interest and update them when their circumstances change. The experts are also expected to declare conflicts of interest before starting certain tasks for their panel.
Potential conflicts of interest are one of several factors that will influence the selection of advisors for the expert panels. The Commission is also keen to ensure the overall composition of the experts on each panel results in "adequate and up-to-date clinical, scientific or technical expertise" and "balanced geographical representation."
Advisors appointed to the expert panels will serve three-year terms that can be renewed and receive compensation of €450 ($495) a day. The panels will appoint a chair and vice chair from among their members. Those leadership positions will also run for three-year terms.
The publication of the terms of the expert panel marks another small step forward in the EU’s efforts to get ready for MDR, which comes into effect in May. This week, notified body BSI issued the first conformity notice under MDR but the signs of progress have yet to alleviate concerns the regulatory system will not be ready in time.
The 11 areas are:
1.) Orthopaedics, traumatology, rehabilitation and rheumatology.
2.) Circulatory system.
4.) Respiratory system, anaesthesiology and intensive care.
5.) Endocrinology and diabetes.
6.) General and plastic surgery and dentistry.
7.) Obstetrics and gynaecology, including reproductive medicine.
8.) Gastroenterology and hepatology.
9.) Nephrology and urology.
11.) In-vitro diagnostic medical devices.