EU MDR Article 15 (PRRC) - Rights and Responsibilities of the Person Responsible for Regulatory Compliance
This course provides a clear and practice oriented introduction to the role, rights, and responsibilities of the Person Responsible for Regulatory Compliance (PRRC) under Article 15 of the Regulation (EU) 2017/745 (EU MDR). Participants gain a solid understanding of the regulatory expectations, required qualifications, and organizational interfaces of the PRRC. The training explains how the PRRC ensures compliance across the entire product lifecycle, how responsibilities are fulfilled in daily operations, and how legal protections and liability considerations apply. Practical examples illustrate how the PRRC function can be effectively integrated into existing quality and regulatory systems.
Course Outline
- Regulatory foundations and Article 15 MDR requirements
- Rights, responsibilities, and qualifications of the PRRC
- PMS, vigilance, and reporting obligations
- Complaint handling and field experience evaluation
- Technical documentation and QMS interfaces
- Distinction between PRRC and §31 MPG Safety Officer
- Supplier agreements and subcontractor oversight
- Liability, sanctions, and legal protections
- Practical examples and implementation strategies
Learning Outcomes
Understanding the Regulatory Framework
- Legal foundations for medical devices in Europe and Germany
- Requirements of Article 15 EU MDR
- Rights, responsibilities, and qualification criteria for the PRRC
- Transitional provisions and special regulatory considerations
Fulfilling PRRC Responsibilities in Practice
- Post market surveillance and vigilance processes
- Reporting obligations and timelines for incidents
- Handling complaints, service cases, market data, and field experience
- Technical documentation requirements
- Interfaces with the quality management system
Differentiating Roles and Manage Interfaces
- Differences between the PRRC and the Safety Officer under §83 MPDG
- Collaboration with Regulatory Affairs, Quality, R&D, and suppliers
- Requirements for agreements with suppliers and subcontractors
Recognizing Risks, Sanctions, and Liability
- Legal protection for the PRRC
- Potential sanctions and liability implications
- Documentation expectations to support defensible decision making
Who Should Attend
- Medical device manufacturers
- Persons Responsible for Regulatory Compliance (PRRC)
- Authorized Representatives
- Safety Officers under §83 MPDG
- Regulatory Affairs Managers
- Quality Management representatives
Why You Should Attend
This course is ideal for PRRC candidates and for professionals who need a clear and actionable understanding of the PRRC role under the MDR. It equips participants to interpret regulatory expectations, manage responsibilities effectively, and integrate the PRRC function into organizational processes. The training provides practical insights into documentation, vigilance, PMS, and cross functional collaboration, helping PRRCs and manufacturers build robust and compliant workflows.
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