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Focus on Regulation

Publication of rules on designation of expert panels under the Medical Devices Regulations

1.            Introduction

In the process of getting ready for the implementation of the forthcoming medical devices Regulations the European Commission published on 10 September 2019 the Commission Implementing Decision (EU) 2019/1396 (Decision) laying down rules on designation of expert panels in the field of medical devices. These expert panels are to be designated to provide scientific, technical and clinical assistance to the Commission, the Medical Device Coordination Group (MDCG), Member States, notified bodies and manufacturers under the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). These expert panels will also be consulted by notified bodies as part of the conformity assessment of high-risk medical devices.

2.            Rules contained in the Decision

The Decision provides 11 areas in which one expert panel will be designated:

  1. Orthopaedics, traumatology, rehabilitation, rheumatology;
  2. Circulatory system;
  3. Neurology;
  4. Respiratory system, anaesthesiology, 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;
  10. Ophthalmology;
  11. In-vitro diagnostic medical devices (IVD).

The Decision provides that advisors shall be appointed to the expert panels for a term of three years following a call for expression of interest and consultation with the MDCG. The call for expression of interest will indicate the selection criteria. These criteria should ensure the selection of highly qualified advisors with a sufficient level of up-to-date clinical, scientific or technical expertise in the relevant abovementioned areas and who reflect a diversity of geographical origins and scientific and clinical approaches.

The Decision further provides rules on organisation and procedure for expert panels as well rules on remuneration. Following the Annex of the Decision advisors will be paid 450 € per full working day.

Finally, the European Commission provides in its Decision that advisors appointed or assigned will act with independence, impartiality, objectivity and commitment to public interest and will follow transparency and confidentiality rules. This includes the declaration of potential conflicts of interest and not having financial or other interests in medical device industries, notified bodies or any other organisation.

The call for experts will be launched later in 2019 and published in the Official Journal of the European Union. Once the call is published, candidates should make sure that they fulfil all the eligibility criteria, fill out the online application form and attach their CV and declaration of interest.