Knowledge · PRRC
PRRC — person responsible for regulatory compliance
Article 15 EU MDR: requirements, tasks and shaping of the role.
The PRRC (person responsible for regulatory compliance) under Article 15 of the EU MDR is the person in the manufacturer’s organisation who checks and ensures the conformity of devices before release. Every manufacturer must nominate such a person; qualification and experience requirements are defined.
Requirements
- University degree in law, medicine, pharmacy, engineering or natural sciences AND at least one year of experience in regulatory affairs for medical devices,
- OR four years of professional experience in regulatory affairs without a university degree.
Tasks (Art. 15(2))
- Checking conformity before release
- Drawing up the technical documentation and declaration of conformity
- Compliance with post-market surveillance obligations
- Compliance with vigilance reporting obligations
PRRC in small companies
Small manufacturers can delegate the PRRC task to external persons ensuring the required experience — this is where INOPREX’s interim PRRC service applies.
Frequently asked questions
Can several persons be PRRC?
Yes, the role can be distributed across several persons; at least one must be nominated.
Applied to your project
We apply these rules directly to your project — from classification to market access. First assessment within two working days.