Person Responsible for Regulatory Compliance (PRRC) – Safety & Compliance According to MDR
The EU Medical Device Regulation (MDR, Article 15) requires manufacturers and authorized representatives to appoint a Person Responsible for Regulatory Compliance (PRRC).
This role is essential for MDR compliance and includes:
- Monitoring product compliance with the MDR
- Ensuring technical documentation and conformity assessment
- Regulatory oversight of post-market surveillance (PMS & Vigilance)
- Collaboration with Notified Bodies and authorities
As an external PRRC, we take on this responsibility for your company or train your staff to build internal expertise. With our know-how, you ensure that your medical devices meet current regulatory requirements—legally compliant, efficient, and practical.
Ensure regulatory security with a qualified PRRC at your side.