Person Responsible for Regulatory Compliance (PRRC): A Critical Role in MDR Compliance
Understanding the essential role of the Person Responsible for Regulatory Compliance (PRRC) under EU MDR. Learn about requirements, responsibilities, and implementation.
A Person Responsible for Regulatory Compliance (PRRC) is a mandatory designated individual required under Article 15 of EU MDR 2017/745 and IVDR 2017/746. Every manufacturer placing medical devices or IVDs on the EU market must appoint at least one PRRC who is permanently and genuinely available to ensure ongoing regulatory compliance — from device conformity checks before release through to post-market surveillance and incident reporting.
Understanding the PRRC Role
The PRRC serves as a cornerstone of regulatory compliance within medical device organizations, ensuring:
- Conformity verification before device release
- Technical documentation and EU declaration of conformity maintenance
- Post-market surveillance obligations
- Reporting of serious incidents
- Compliance with regulatory requirements
Key Responsibilities
A PRRC's duties encompass several critical areas:
- Quality Management
- Ensuring device conformity with quality system requirements
- Overseeing batch release procedures
- Maintaining technical documentation
- Post-Market Activities
- Coordinating post-market surveillance
- Managing incident reporting
- Implementing corrective actions
- Documentation Management
- Maintaining technical documentation
- Ensuring EU declaration of conformity updates
- Managing regulatory submissions
PRRC Requirements
The role demands specific qualifications:
- University degree in law, medicine, pharmacy, engineering, or relevant scientific discipline
- Four years of professional experience in regulatory affairs or quality management
- OR five years of professional experience in medical device regulatory affairs
Expert PRRC Services at Advena Medical
At Advena Medical, we provide comprehensive PRRC solutions:
- Qualified PRRC appointment
- Technical documentation review
- Quality system oversight
- Post-market surveillance management
- Incident reporting coordination
- Regulatory compliance monitoring
Benefits of Professional PRRC Services
Working with experienced PRRC professionals ensures:
- Full MDR compliance
- Expert regulatory oversight
- Efficient quality management
- Timely incident reporting
- Peace of mind for manufacturers
Getting Started
Ready to strengthen your regulatory compliance? Visit our PRRC services page to learn how we can support your MDR compliance needs.
Frequently Asked Questions
Who is required to appoint a PRRC under EU MDR?
All manufacturers of medical devices or IVDs placing products on the EU market must appoint at least one Person Responsible for Regulatory Compliance (PRRC) under Article 15 of EU MDR 2017/745. Micro and small enterprises are exempt from having a PRRC in-house but must ensure permanent availability of a qualified PRRC.
Can a PRRC be outsourced?
Yes. Micro and small enterprises (as defined by EU Recommendation 2003/361/EC) may contract with an external organisation or individual to fulfil the PRRC role, provided the PRRC is permanently and genuinely available to the manufacturer. Advena Medical offers outsourced PRRC services for manufacturers of all sizes.
What qualifications does a PRRC need?
A PRRC must hold a university degree in law, medicine, pharmacy, engineering, or a relevant natural science, plus at least four years of professional experience in regulatory affairs or quality management systems in the medical device sector. Alternatively, five years of relevant professional experience without a degree may suffice in certain cases.
What are the main responsibilities of a PRRC?
A PRRC ensures device conformity before release, maintains technical documentation and the EU Declaration of Conformity, manages post-market surveillance, reports serious incidents to competent authorities, and oversees compliance with all applicable MDR requirements.