Person responsible for regulatory compliance

In practice

Qualification, either: a university degree in law, medicine, pharmacy, engineering or another relevant scientific discipline, plus at least one year of professional experience in regulatory affairs or quality management systems for devices; or four years of experience in those fields. Five responsibilities are listed in paragraph 3, including verifying conformity before release and keeping the technical documentation up to date. Micro and small enterprises need not employ this person, but must have one permanently and continuously at their disposal.

Official sources