PRRC – Person Responsible for Regulatory Compliance Article 15 MDR (EU) 2017/745 and IVDR (EU) 2017/746

Training objectives:
• Understand the regulatory context of PRRC roles and responsibilities
• Understand the qualification needed to select the PRRC within your company
• Understand in what particular situation the role of the PRRC can be outsourced
• Analyse the impact on the QMS documentation

Training content:
• Regulatory context

1. Review of Article 15 requirements
2. Requirements regarding PRRC’s qualification

• Implementation of the requirements

1. Analysis of the roles and responsibilities of the PRRC
2. How to implement in practice the requirements of Article 15
3. Outsourcing and sharing the roles and responsibilities of the PRRC
4. Liability

• Impact on QMS documentation

1. Job description
2. Quality Manual
3. Human Resources process
4. Pos-market Surveillance and Vigilance processes
5. Design and Development and Manufacturing processes