For manufacturers of custom-made devices, does this mean they can have a PRRC with 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
- at least two years of professional experience within a relevant field of manufacturing
Why would experience within a relevant field of manufacturing be able to replace experience in regulatory affairs or in quality management systems relating to medical devices?