PRRC – Person Responsible for Regulatory Compliance
A comprehensive guide to understanding who, what, and why PRRC requirements matter under EU MDR and IVDR regulations.
The EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) introduced significant new requirements for medical device manufacturers. One of the most critical requirements is the identification of a Person Responsible for Regulatory Compliance (PRRC) – clearly outlined in Article 15 of both regulations.
This comprehensive guide provides a quick reference to PRRC requirements, qualifications, responsibilities, and implementation best practices.
Who Should Be the PRRC?
Under EU MDR and IVDR requirements, manufacturers and authorised representatives must identify at least one person who is permanently and continuously available and responsible for regulatory compliance.
Required Qualifications
The PRRC must meet one of the following qualification criteria:
Higher Education Degree
A higher education degree in:
- Medicine
- Natural sciences
- Engineering
- Law
Equivalent Experience
At least 3 years of professional experience in regulatory affairs or quality assurance for medical devices.
Combined Approach
A combination of relevant education and professional experience in medical device regulatory compliance or quality management.
Employment Structure: Internal vs. Subcontracted
The employment arrangement depends on the size of your organization:
| Organization Size | PRRC Arrangement | Key Requirements |
|---|---|---|
| Medium & Large Companies (>250 employees or €50M turnover) |
Must be an internal employee | PRRC must be permanently and continuously available within the organization |
| Small Enterprises (50-249 employees or €10-50M turnover) |
Can be internal or subcontracted | Must be permanently and continuously at the company's disposal |
| Micro Enterprises (<50 employees or <€10M turnover) |
Can be subcontracted to external supplier | Must be permanently and continuously available; external arrangement must be documented in contract |
| Authorised Representatives | Can subcontract to third party | Must be clearly identified and permanently available; contract must define role and qualifications |
Where Should the PRRC Be Based?
The PRRC does not need to be based in a specific geographical location, but they must be:
- Permanently and continuously available to the manufacturer or authorised representative
- Able to respond promptly to regulatory compliance matters
- Accessible during normal business hours and for emergencies
- Capable of coordinating with regulatory authorities when required
- Able to maintain documentation and records as required by regulations
Subcontracting Considerations
When the PRRC role is subcontracted (for micro and small enterprises, or by authorised representatives), the following must be clearly documented in the contract:
Essential Contract Elements
- Identification of the PRRC and their qualifications
- Clear definition of responsibilities and scope of work
- Agreement that the person is permanently and continuously at the company's disposal
- Procedures for emergency contact and escalation
- Confidentiality and data protection obligations
- Duration of the arrangement and termination clauses
- Backup arrangements if the primary PRRC becomes unavailable
What Do They Have to Do?
Article 15(3) of both EU MDR and IVDR outlines the key functions and responsibilities of the PRRC. These responsibilities are comprehensive and critical to regulatory compliance:
Core PRRC Responsibilities
Regulatory Compliance Monitoring
Ensure the manufacturer or authorised representative complies with all applicable regulatory requirements under MDR/IVDR.
Technical Documentation
Oversee the preparation, maintenance, and updating of technical documentation required for regulatory submissions and compliance.
Quality Management System
Monitor the implementation and effectiveness of the quality management system (QMS) as required by regulations.
Post-Market Surveillance
Ensure post-market surveillance activities are conducted appropriately and that safety data is monitored and reported.
Vigilance & Adverse Events
Oversee vigilance procedures and ensure adverse events are reported to competent authorities as required by regulations.
GSPR Conformity
Ensure General Safety and Performance Requirements (GSPR) are met and maintained throughout the device lifecycle.
Regulatory Authority Communication
Serve as the primary point of contact with regulatory authorities and manage all regulatory correspondence.
Training & Documentation
Ensure relevant personnel are trained on regulatory requirements and maintain comprehensive compliance documentation.
Additional Guidance from MDCG 2019-7
The Medical Device Coordination Group (MDCG) document 2019-7 provides additional context and cross-references the PRRC obligations to broader manufacturer and authorised representative responsibilities. This guidance should be reviewed alongside Article 15 for comprehensive understanding.
Multiple PRRC Arrangements
If you choose to have more than one PRRC, they can share the responsibilities. Any split of responsibilities must be clearly agreed and documented in writing. This arrangement can be effective for larger organizations with complex regulatory portfolios across multiple therapeutic areas or device categories.
Why Do You Need a PRRC?
The PRRC requirement serves several critical purposes in the regulatory framework:
Clear Accountability & Responsibility
The primary objective is to establish clear responsibility for monitoring compliance on key regulatory activities. By designating a specific person or persons with relevant qualifications and experience, regulations ensure that critical compliance functions are not overlooked or delegated without proper oversight.
Enhanced Scrutiny & Compliance Culture
The PRRC requirement creates a "golden thread" of compliance that runs through both MDR and IVDR. This seeks to provide increased scrutiny around compliance to regulatory requirements, ensuring that:
- Compliance is not treated as an afterthought but as a core business function
- Regulatory requirements are actively monitored and maintained
- Changes to regulations are promptly identified and implemented
- Regulatory risks are proactively managed
- A culture of compliance is embedded throughout the organization
Practical Benefits for Organizations
Once in place and responsibilities are clearly set out and agreed, the PRRC role should actually assist companies in maintaining compliance with their obligations by:
- Providing a single point of accountability for regulatory matters
- Ensuring consistent interpretation and application of regulations
- Facilitating communication between internal departments and external authorities
- Reducing compliance gaps and regulatory risks
- Supporting efficient regulatory submissions and inspections
- Enabling proactive regulatory strategy development
Implementation Best Practices
For Companies Already on the EU Market
If your company is already marketing devices in the EU under MDR/IVDR, ensure that:
- A PRRC has been formally identified and documented
- The PRRC meets the required qualifications under Article 15
- The PRRC's responsibilities are clearly defined and communicated
- Adequate resources and support are provided to the PRRC
- The arrangement is documented in writing (especially if subcontracted)
- Regular reviews are conducted to ensure the arrangement remains effective
- Backup arrangements exist in case the primary PRRC becomes unavailable
For New Market Entrants
When planning entry into the EU market, identify and establish your PRRC arrangement early in the process. This ensures:
- Regulatory compliance from the start of market entry
- Smooth interaction with notified bodies and regulatory authorities
- Efficient preparation of regulatory submissions
- Clear understanding of regulatory obligations
- Proper documentation for regulatory inspections
Need Help Establishing Your PRRC?
Navigating PRRC requirements and ensuring full compliance with Article 15 of MDR/IVDR requires specialized regulatory expertise. Eclevar MedTech has extensive experience helping manufacturers and authorised representatives establish effective PRRC arrangements that meet regulatory requirements and support long-term compliance.
Our team can assist with identifying qualified candidates, documenting responsibilities, and ensuring your PRRC arrangement is compliant and effective.
Contact Us for PRRC SupportKey Takeaways
- EU MDR and IVDR require identification of at least one Person Responsible for Regulatory Compliance (PRRC)
- The PRRC must have a higher education degree in relevant field OR 3+ years of professional experience in regulatory affairs/QA for medical devices
- Medium and large companies must employ the PRRC internally
- Micro and small enterprises can subcontract the PRRC role to external suppliers
- Authorised representatives can subcontract the PRRC role but must clearly document the arrangement
- The PRRC must be permanently and continuously available to the organization
- Key PRRC responsibilities include regulatory compliance monitoring, technical documentation, QMS oversight, and post-market surveillance
- The PRRC serves as the primary point of contact with regulatory authorities
- The PRRC requirement establishes a "golden thread" of compliance throughout the organization
- Multiple PRRCs can share responsibilities if clearly documented in writing
- Companies already on the EU market should verify their PRRC arrangement meets all requirements
- Eclevar MedTech can support you in establishing and maintaining an effective PRRC arrangement
Conclusion
The Person Responsible for Regulatory Compliance is a cornerstone of the EU MDR and IVDR regulatory framework. This requirement ensures that manufacturers and authorised representatives maintain clear accountability for regulatory compliance and establish a culture of continuous compliance monitoring.
By understanding the qualification requirements, employment arrangements, and core responsibilities of the PRRC, organizations can establish effective compliance structures that support regulatory success and reduce compliance risks.
Whether you're a large multinational manufacturer establishing a PRRC for the first time, or a small enterprise exploring subcontracting options, the key is to ensure that your PRRC arrangement is properly documented, adequately resourced, and actively engaged in regulatory compliance activities.
The PRRC is not just a regulatory checkbox – when implemented effectively, this role becomes a strategic asset that helps organizations navigate complex regulatory landscapes, maintain compliance, and support successful regulatory submissions and inspections.
For manufacturers seeking to establish or optimize their PRRC arrangements, working with experienced regulatory consultants and CRO partners can ensure that your PRRC is positioned for success and that your organization maintains full compliance with Article 15 requirements.
Eclevar MedTech specializes in supporting medical device manufacturers through all aspects of regulatory compliance, including PRRC establishment and management. Our expertise in MDR/IVDR requirements and regulatory best practices positions us as your ideal partner for navigating PRRC requirements and ensuring long-term regulatory success.