The Medical Device Regulation (MDR) (EU) 2017/745 and In Vitro Device Regulation (IVDR) (EU) 2017/746 introduced a new mandatory role in Article 15: the Person Responsible for Regulatory Compliance or ‘PRRC’. Wondering what the meaning of the PRRC-role is and where you can find the right person? Then read on this blog post by our member QbD!
PRRC: meaning of this new role
The Medical Device Regulation (MDR), which came into force in May 2021, and the In Vitro Medical Devices Regulation (IVDR), which just came into force on the 26th of May 2022, introduced a new obligatory role: the Person Responsible for Regulatory Compliance or ‘PRRC’.
Article 15 of both regulations announced this with some main clear guidelines on the need to have the necessary PRRC qualifications, requirements and responsibilities listed.
It also indicates who can be designated to take on this role in the case of ‘micro and small enterprises’, as these do not always have the necessary qualified staff. This is one of the topics that will be discussed in this blog post.
Other topics to be discussed are:
- What does the regulation mean by the necessary qualifications?
- When do you need to contact your PRRC?
- What if you need a PRRC and an authorized representative?
Read this article by QbD if you want to deep dive into the meaning of this new PRRC role with some practical guidance!