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

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