The MDR/IVDR envisages expert panels, who shall assist the European Commission, the Medical Devices Coordination Group, Member States, Notified Bodies and manufacturers in technical, scientific and clinical aspects.
Now a decision of the European Commission (Implementing Decision (EU) 2019/1396) has been published which describes the designation and functioning of these expert panels in more detail.
There will be 11 expert panels covering different medical areas where a need for expertise is seen. In addition, there will be another expert panel dealing with additional tasks (MDR Annex IX, section 5.1 letter c). The Medical Devices Coordination Group appoints the advisors for a term of 3 years and paid €450 per each full working day. Their independence, impartiality and objectivity should not be affected, which should be verified by a written declaration of interests. Among other things, the names of the advisors appointed, the common rules of procedure and the opinions, views and positions should be made publicly accessible in order to represent a transparent working method.
Article 54 of the MDR states in Section 1 that Notified Bodies must consult a panel of experts for special high risk products when carrying out a conformity assessment. Conversely, this means that these expert panels must already be in place for a manufacturer to complete the clinical evaluation of his high-risk product. Therefore, it is currently not possible to certify such products according to MDR and thus put them on the market. If no expert panels have been appointed by May 2020, it is expected that the concerned products will initially be certified without corresponding expertise.