Article 15(1) of the EU MDR and the IVDR requires a person with expertise in the field of medical devices, which is defined as qualifications that are demonstrated by either:

(a) 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:

(b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.