Article 15(1) of the MDR and the IVDR calls for a person possessing the requisite expertise in the field of medical devices, which is defined as qualifications that are demonstrated by either:
- a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree
- or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices
- or four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
While formal qualification is easily documented with a diploma or certificate, professional experience in medical device regulatory affairs or in quality management systems (referring to experience gained in the EU) has to be demonstrated as well. Qualification based on professional experience has to be substantiated with documents such as a work contract, organisation chart, training evidence or internal records such as document releases.
In the additional guidance document MDCG 2019-7, the EU Medical Device Coordination Group clarifies how to interpret Article 15. With regard to the required qualifications, the guidance adds that, for the purpose of fulfilling the requirements in Article 15(1), qualifications acquired outside the EU should have been recognised by an EU Member State as equivalent to the corresponding qualification in the EU.
