PRRC Services — MDR Article 15 Compliance Without the Full-Time Hire
EU MDR Article 15 requires every manufacturer — including micro-enterprises and SMEs — to have a qualified Person Responsible for Regulatory Compliance (PRRC). If you don't have a qualified individual in-house, MEGACERT can act as your outsourced PRRC — giving you Article 15 compliance without the cost of a permanent senior regulatory hire.
What Is the PRRC and Why Is It New Under MDR?
The concept of a Person Responsible for Regulatory Compliance (PRRC) was introduced by EU MDR 2017/745 Article 15 and has no direct equivalent in the predecessor MDD 93/42/EEC. It represents a significant regulatory governance upgrade: the European Commission wanted to ensure that every manufacturer placing devices on the EU market has a named, qualified individual accountable for regulatory compliance.
Who Qualifies as a PRRC? MDR Article 15(1) specifies that the PRRC must have:
- A diploma, certificate, or evidence of formal qualification in law, medicine, pharmacy, engineering, or natural sciences, AND at least one year of professional experience in regulatory affairs or QMS in the medical device field.
- For micro-enterprises (fewer than 10 employees, annual turnover ≤ €2M), a person from within the enterprise may fulfil the role even without meeting all of the above qualifications — provided they have adequate knowledge of the regulatory requirements.
- Under MDR Article 15(3), the PRRC is responsible for ensuring that conformity of devices is appropriately checked before release.
- The PRRC ensures Technical Documentation and Declaration of Conformity are prepared and kept up to date.
- Post-market surveillance obligations are met and reporting obligations (vigilance, EUDAMED) are fulfilled.
- Clinical investigations are notified per Articles 62 to 80 of the MDR.
MEGACERT's outsourced PRRC service gives you a named, qualified individual who meets Article 15 requirements and is formally designated in your QMS documentation.
MEGACERT's Outsourced PRRC Service
Named PRRC Designation
A qualified MEGACERT regulatory expert is formally designated as your PRRC and named in your Quality Management System documentation, with a signed PRRC Designation Agreement.
Device Release Oversight
We review and sign off on device releases, confirming that conformity assessment procedures have been correctly followed and Technical Documentation is complete and current.
Regulatory Monitoring
We monitor EU MDR/IVDR guidance updates, MDCG documents, and NCA communications relevant to your device types — and brief you on any changes requiring action.
EUDAMED & Reporting
We ensure your EUDAMED registrations are current, PSUR/PMSR reports are filed on schedule, and any vigilance events are reported within the required timeframes.
QMS Integration Support
We work with your existing ISO 13485 QMS to ensure PRRC responsibilities are embedded in your SOPs, training records, and management review process.
Frequently Asked Questions
Need a qualified PRRC without the overhead of a full-time hire? Contact MEGACERT to discuss outsourced PRRC services.
Ask About Our PRRC Service →