Person Responsible for Regulatory Compliance (PRRC) – EU & Swiss Regulations

by | Aug 31, 2023 | Past Trainings

This training currently has no open sessions. If you would like to attend, please leave us a message, and we will inform you when a new date is planned.


Training Objectives:

  • Understand the regulatory context of PRRC roles and responsibilities in both EU and CH regulations
  • Understand the qualification needed for selecting the PRRC within an organization
  • Understand in what situation(s) the role of the PRRC can be outsourced
  • Analyze the impact on the QMS documentation


Training Content:

Regulatory context & qualification requirements:

  • Review of Article 15 requirements of MDR (EU 2017/745) and IVDR (EU 2017/746)
  • Review of Article 49, 51 requirements of Medical Device Ordinance (MedDO)
  • Review of Article 42, 45 requirements of Ordinance on In Vitro Diagnostic Medical Devices (IvDO)
  • Requirements regarding PRRC’s qualification

Implementation of the requirements:

  • Analysis of the roles and responsibilities of the PRRC
  • How to implement in practice the requirements from EU & CH regulations
  • Outsourcing and sharing the roles and responsibilities of the PRRC
  • Liability

Impact on QMS documentation:

  • Job description
  • Quality Manual
  • Human Resources process
  • Pos-market Surveillance and Vigilance processes
  • Design and Development and Manufacturing processes
  • Understanding Quality Management Systems as per ISO 13485
  • Understanding the medical device regulatory framework in the EU and CH


Training Format:

  • Presentation with interactive discussions
  • Exercises during the training
  • End of training assessment (participants will receive a training certificate)


Who Should Attend:

  • Managers and employees working in Quality Assurance or Regulatory Affairs departments of medical device manufacturing companies 
  • Managers and employees working in Research and Development departments of medical device manufacturing companies 
  • Technical medical device consultants and associates 
  • Auditors of medical devices