TEAM-PRRC is the non-profit European Association dedicated to the new profession of "Person responsible for regulatory compliance" (PRRC) which originated in Article 15 of the Regulation (EU) 2017/745 (MDR) and in Article 15 of the Regulation (EU) 2017/746 (IVDR) of the European Parliament and the Medical Device Council.
These Regulations specify the requirements of training and/or professional experience necessary to hold the position of PRRC.
It is a unique regulatory requirement that applies only within the European Union (EU).
The Association was created to help PRRCs to more confidently assume this new profession which has considerable responsibilities in the design, manufacture and supply of medical devices and in vitro diagnostic devices.
By the networking it allows, the framework it provides and the rigor of its analysis of requirements and guidance available, TEAM-PRRC Association aims to promote greater security for the PRRC professional themselves, as well as for patients and health authorities.
A template Letter of Appointment to act as Person Responsible for Regulatory Compliance within the organization of the Manufacturer (or the Authorised Representative), according to the European regulations (EU) 2017/745 or (EU) 2017/746.
- A template Agreement for external PRRC services for a Manufacturer according to the European regulations (EU) 2017/745 or (EU) 2017/746.