(1) To become active member, the requisite expertise for PRRCs, as refered to in EU MDR or IVDR Article 15, shall be demonstrated by either of the following qualification. It is not necessary to be currently employed as PRRC :
1- A diploma, certificate or other evidence of formal qualification, awarded on completion a university degree or of a course of study recognised as equivalent by the Member State concerned, in:
a. law
b. medicine
c. pharmacy
d. engineering
e. another relevant scientific discipline
PLUS at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices.
Or
2- Four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
If you meet these criteria, you may become a TEAM-PRRC active member.
(2) Otherwise you may become as individual a TEAM-PRRC supporting member, participating to all activities, but without deliberative vote or mediation help.
(3) And the last possibility to join TEAM-PRRC, for an individual or a corporate, is to become sponsor.
