About US

TEAM-PRRC was established in 2020 as a non-profit organization dedicated to the profession of « Person Responsible for Regulatory Compliance » (PRRC) according to Article 15 of the European Regulations on Medical Devices: MDR (EU) 2017/745 and IVDR (EU) 2017/746 :

To help regulatory affairs experts in the healthcare system understand their obligations as PRRC,
To support PRRCs with additional guidance and best practice documents, ensuring harmonised implementation of the requirements in the EU, and
To represent the interests of PRRCs in front of the European regulators and stakeholders, including the EU Commission, EU Ministries, Competent Authorities, Medical Associations, Industry Associations, and Notified Bodies.

TEAM-PRRC is led by key subject matter experts who volunteered to support the implementation of the regulations (MDR & IVDR) by dedicating part of their time to this activity.

Members

nationalities

annual summit

webinars

Who we are ?

A European association that aims to promote active compliance to MDR & IVDR

A non-profit organization dedicated to the profession of “Person Responsible for Regulatory Compliance” (PRRC)

Directed by volunteers who are experts in field of MDR & IVDR

Supported by legal experts in the field of medical device legislation

Objectives

TEAM-PRRC is established with the following objectives:

Establish a platform for all PRRCs following the requirements of the regulations.
Ensure more clarities regarding the qualification requirements and obligations of the PRRCs.
Develop and implement system specifications towards recognized qualification criteria of PRRC.
Establish, maintain and develop continuous knowledge sharing across all PRRCs.
Represent the need of all PRRCs via one single non-profit organization towards more harmonization.
Exchange experience on issues faced by PRRC in their daily activities; propose and exchange solutions.
Establish, maintain and develop a high level of professionalism of PRRC.
Exchange information with health authorities in charge of national, European and international regulation; promote understanding of PRRCs’ responsibilities to other stakeholders.
Act as a moderator and support PRRCs in conflicts or disputes encountered during their day-to-day activities.
Aim for enhancement of Public Health.
Pursue for mutual assistance between TEAM-PRRC members.