Welcome to TEAM-pRRC

About US

TEAM-PRRC has been established in 2020 as a non-profit organization dedicated to the profession of « Person Responsible for Regulatory Compliance » (PRRC) according to the article 15 of the European regulations on Medical Devices: (EU) 2017/745 (« MDR ») and (EU) 2017/746 (« IVDR »):
·       to help regulatory affairs experts in the healthcare system understanding 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 interest 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 and IVDR) by dedicating part of their time for this activity.

+ 500

members

+ 30

Nationalities

3

Annual Summit

+ 50

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.

How TEAM-PRRC can help you ?

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