EC Explains New MDR, IVDR Rules for Designating Expert Device Panels
The European Commission (EC) on Wednesday published an implementing decision on how new medical device expert panels will be designated under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).The panels will provide scientific, technical and clinical assistance to the EC, the Medical Device Coordination Group (MDCG), member states, notified bodies and device manufacturers. In particular, the implementing decision notes that notified bodies are required to carry out consultations of expert panels on clinical evaluations of certain high-risk devices in the context of MDR and on performance evaluations of certain high-risk in vitro diagnostic devices in the context of IVDR.
Panel experts will be objective (EC says they must have no financial or other interests in the device or notified body industries), appointed for three-year terms and paid €450 per each full working day. The experts will be paid for their preparatory work and participation (in person or electronically) in the expert panel meetings and in other related activities.
“The advisors in the expert panels should be appointed on the basis of objective criteria and following a public call for expression of interest,” the EC says. “The selection criteria included in the call for expression of interest should ensure that highly qualified advisors with a sufficient level of up-to-date clinical, scientific or technical expertise in the relevant identified areas are selected, and that advisors are able to act independently and in the public interest.”
Panels will cover each of the following 11 areas:
- Orthopedics, traumatology, rehabilitation and rheumatology
- Circulatory system
- Neurology
- Respiratory system, anesthesiology and intensive care
- Endocrinology and diabetes
- General and plastic surgery and dentistry
- Obstetrics and gynecology, including reproductive medicine
- Gastroenterology and hepatology
- Nephrology and urology
- Ophthalmology
- In vitro diagnostics
“Expert panels should operate in a transparent and harmonised manner. To this end, common rules of procedure, internal guidance and methodologies for their operation should be established by the coordination committee and be publicly accessible,” the EC says.
Commission Implementing Decision