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Commission ‘pre-notifies’ call for experts

  • Posted by: inetika
  • Category: GLOBAL NEWS

The European Commission has published advance notice of its intention later in the year to seek clinical and other experts to participate in the MDR and IVDR Expert Panels.

The panels are intended to support the assessment of specific high-risk devices and to contribute to the prospective improvement of the overall framework by advising the Commission, the Medical Device Coordination Group, Member States, Notified Bodies and manufacturers. They will respond to consultations on novel, high-risk devices before they are certified. Experts will also be involved in other tasks such as contributing to the development of common specifications for clinical evaluation of device categories, guidance documents or standards.

Selected experts will be appointed to expert panels in a range of relevant fields, such as the cardiovascular system, orthopaedics, neurology, endocrinology, and IVDs. MedTech Europe has already urged the Commission to get on with setting up the Expert Panels and wants to see them established before the end of 2019.

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