The European Commission has announced to publish a call for clinical and other experts in the area of medical devices and in vitro diagnostic devices later in 2019.
The new European Union regulations on medical devices (MDR) and in-vitro diagnostics (IVDR) came into force in 2017. Both regulations require the establishment of expert panels which will have the following purpose:
· to support the assessment of specific high-risk devices, e.g. respond to consultations on novel high-risk devices before being certified for the EU single market;
· to play a part in the development of common specifications for ex. for clinical evaluation, guidance documents or standards;
· to advise the Commission, the MDCG (Medical Device Coordination Group), Member States, Notified Bodies and manufacturers.
The selected experts will then be assigned to the relevant fields of medical devices, such as the cardiovascular system, orthopaedics, neurology, endocrinology, and other areas, as well as in vitro diagnostic medical devices.
Successful applicants will also have the possibility to be appointed for a renewable term of three years or to be included on a list of available experts from which they may be called to assist the panels.
Bianca Sofian
RA Department
September 10, 2019
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