Person Responsible for Regulatory Compliance (PRRC): Roles, Responsibilities, and Best Practices

Interested participants from other time zones are welcome to contact us regarding the training at [email protected].

The introduction of the Person Responsible for Regulatory Compliance (PRRC) under the EU Medical Device Regulation (MDR 2017/745) marked a major shift in the European regulatory landscape. This new mandatory role ensures that every manufacturer and in some cases, Authorized Representatives maintains a high level of regulatory oversight and compliance across all activities related to the conformity and safety of medical devices.

The “PRRC: Roles, Responsibilities, and Best Practices” training is designed to provide participants with a comprehensive understanding of the legal requirements, practical duties and strategic importance of the PRRC function. The course explores how the PRRC fits into the manufacturer’s quality management system, the expectations of Notified Bodies and Competent Authorities and the daily challenges in balancing compliance oversight with operational efficiency.

Through a combination of regulatory interpretation, case studies and practical guidance, this training helps both new and experienced regulatory professionals effectively perform or support the PRRC role in line with EU expectations. 

Key Topics Covered

• Understand the legal basis and regulatory intent behind the PRRC requirement in the MDR
• Clearly identify the mandatory qualifications, competencies, and experience needed for PRRC designation
• Gain detailed insight into the roles, responsibilities, and liabilities of the PRRC, both for in-house staff and external service providers
• Learn how to structure, document, and communicate the PRRC function within the organization and the QMS
• Understand Notified Body and Competent Authority expectations during audits and inspections
• Explore best practices and case studies on establishing an effective and compliant PRRC function

 Benefits of this Training

• Understand the legal and regulatory framework governing the PRRC role
• Gain clarity on the daily responsibilities and strategic importance of the PRRC
• Be able to assess and improve internal processes to support compliance
• Identify potential compliance gaps and how to address them
• Learn from real-world examples and best practices across the industry

Target Audience: Designated or aspiring PRRCs, Regulatory Affairs and Quality Assurance Managers, Consultants or service providers acting in a PRRC capacity for SMEs

Certificate: Participants receive a Certificate of Attendance of DQS MED GmbH

Trainer: Is a highly qualified regulatory expert from DQS MED, a leading Notified Body with deep expertise in conformity assessment under EU MDR.