July 02, 2019
The European Commission (EC) recently released a new guidance on persons responsible for regulatory compliance under the Medical Device Regulation (MDR) and the in vitro Diagnostic Device Regulation (IVDR).
Under Article 15 of MDR and IVDR, companies are required to have at least one employee responsible for regulatory compliance with at least one of the following:
- 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
- four years of professional experience in regulatory affairs or in quality management systems relating to medical devices