Glossary · EU medical devices: MDR
Person responsible for regulatory compliance (PRRC)
Also known as: PRRC, Person responsible for regulatory compliance
Under Article 15 of the EU Medical Device Regulation (EU) 2017/745 and of the IVD Regulation (EU) 2017/746, the person responsible for regulatory compliance (PRRC) is a person with the required expertise whom manufacturers and authorized representatives must have available. The PRRC is responsible at least for checking conformity before release, keeping technical documentation and the declaration of conformity up to date, and fulfilling post-market surveillance and vigilance obligations.
- EU
- MDR
- IVDR
In one sentence
The PRRC (Article 15 MDR and IVDR) is the expert a manufacturer must have available to oversee release, documentation, PMS and vigilance.
Example
A small software company with eight employees contracts an external regulatory consultant as its PRRC, documents the arrangement, and names that person as responsible for the release check of each software version.
How it applies
- Expertise: Article 15 requires expertise shown by a relevant degree (for example in law, medicine, pharmacy or engineering) and professional experience in regulatory affairs or quality management for medical devices, or by longer professional experience in those fields.
- Small companies: Micro and small enterprises need not employ the PRRC in-house but must have the person permanently and continuously at their disposal.
- Authorized representatives: Also need a PRRC for their own duties, separate from the manufacturer’s.
- Independence: The PRRC must not suffer any disadvantage within the organization for properly performing the role. Where several people share the responsibility, their areas are set out in writing.
- Technical documentation: Keep a record of who the PRRC is, their qualification evidence, and the tasks assigned; link the PRRC sign-off to the release decision and to the technical documentation versions released.
PRRC vs. Qualified Person (EU GMP)
Both roles sign off before products reach patients, but they belong to different laws. The PRRC checks device conformity under MDR or IVDR; the Qualified Person certifies each batch of a medicinal product under Directive 2001/83/EC. Neither is the machine-safety “qualified person”, which is a competent worker.