Medical devices expert panels now accepting submissions from NBs for the clinical evaluation consultation procedure

The expert panels in the field of medical devices are now accepting submissions from notified bodies (NBs) for the Clinical Evaluation Consultation Procedure according to the commission website.

About the expert panels

The Medical Devices Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 on In Vitro Medical Devices (IVDR) respectively require the Commission to create expert panels to support the scientific assessment and advice in the field of medical devices and in vitro diagnostic medical devices.

Depending on needs, the expert panels have various tasks including provision of the following:

  • 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
  • advice to the MDCG and the European Commission concerning safety and performance of medical devices and in vitro diagnostic medical devices
  • advice to manufacturers on their clinical development strategy and proposals for clinical investigations
Who are the experts?

Panel members are top-notch experts in their own field appointed by the Commission on the basis of their scientific, clinical and technical expertise following a call for expression of interests. The selection is made by the Commission and the appointment in consultation with the MDCG.

The experts must have:

  • full rights as a citizen of a Member State of the EU, EFTA or Turkey
  • a university degree in a relevant medical or scientific areas
  • at least 10 years of relevant professional experience
  • good knowledge of the English language allowing active participation in the work of the panels

No financial interest or other interest, which could affect their independence, impartiality and objectivity.

It is arguable whether the above requirements are stringent and/or specific enough for someone to be designated ‘top-notch’. Only time will tell.

How many expert panels are there?

Experts are appointed for a term of 3 years, with the possibility of renewal. During this time, they are part of one of 12 panels, which indlue the following:

  • Screening panel – determines whether there is a need for a scientific opinion
  • Orthopaedics, traumatology, rehabilitation, rheumatology
  • Circulatory system
  • Neurology
  • Respiratory system, anaesthesiology, intensive care

The Commission provides a Secretariat for the expert panels to support the efficient functioning of the expert panels. Its task includes the identification and management of potential conflicts of interests, the supervision of the work, the monitoring of compliance with the rules of procedure, and the publication of opinions, views and positions.

Further information is available on the commission website at the link below.

Source: Europa website