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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 represent and 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.
TEAM-PRRC is totally independent from any organization, does not receive any subsidy, and only exists thanks to the contributions of its members.
- Fees to become an active member : 250 € per year
TEAM-PRRC THIRD ANNUAL SUMMIT:
2024, October 17 & 18 ; MALAGA (Spain)
Compliant together, let's make it a new success !!!!!!!
Registrations are now open!!
YOU ARE ALL VERY WELCOME!!
TEAM-PRRC THIRD ANNUAL SUMMIT: 2024, October 17 & 18 ; MALAGA (Spain)
SPONSORING opportunity: < Contact >
You said eQMS!
A series of webinars about digital tools:
Season One : How could PPRC be helped in DHR, UDI, & traceability regulatory database compliance?
prepared by: Stéphane ANCEL Sales manager of ACKOMAS
moderated by: Ajda MIHELCIC, Manager, Regulatory Intelligence & Innovation at Obelis group
June, 4th 17:00 - 18:30 CET ; Agenda: 45' presentation / 45' Q&A
Public webinar, in English on TEAM-PRRC Zoom platform ; Recorded ;
Video records and slides reserved to TEAM-PRRC active members on TEAM-PRRC platform.
Free of charges but registration required HERE
Latest updates on EUDAMED
A webinar with the latest news on EUDAMED
Prepared by: Ajda MIHELCIC, Manager, Regulatory Intelligence & Innovation at Obelis group
June, 27th 17:00 - 18:00 CET
Webinar, in English on TEAM-PRRC Zoom platform and reserved to TEAM-PRRC active members ; Recorded ;
Video records and slides reserved to TEAM-PRRC active members on TEAM-PRRC platform
Registration required HERE
Prochaines sessions 2024
PCVRR : comprendre ce rôle de façon théorique et pragmatique !
Par Elem AYNE, notre présidente !!
Boumans Regulatory Consulting reserves rights to control for TEAM-PRRC up to date membership.
6 February 2024 | Short Online Course
14 May 2024 | Short Online Course
19 September 2024 | Short Online Course
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.