Person Responsible for Regulatory Compliance (PRRC): A Critical Role in MDR Compliance
5 min read
The EU Medical Device Regulation (MDR) introduced the mandatory role of Person Responsible for Regulatory Compliance (PRRC), marking a significant shift in how manufacturers manage regulatory compliance.
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.