Training: Person Responsible for Regulatory Compliance (PRRC)

EU & CH regulations

Speaker: Dr Valentina Lintas
Duration: 3.5 hours
Date: October 9th 2025, Online
8:00 AM – 11:30 PM US Eastern Daylight Time (EDT)
2:00 PM – 5:30 PM Central European Summer Time (CEST)

• 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 and 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
  • Post-market Surveillance and Vigilance processes
  • Design and Development and Manufacturing processes

• Training Format

  • Presentations with interactive discussions
  • Group and individual exercises
  • End of training assessment

• Prerequisite

  • Understanding of Quality Management Systems as per ISO 13485
  • Understanding of medical device regulatory framework in EU and CH

• Target Audience

  This course is designed for designated PRRCs, regulatory affairs professionals, quality assurance personnel, medical device manufacturers (particularly SMEs), EU Authorized Representatives, and consultants or advisors involved in EU medical device or IVD compliance - those responsible for ensuring conformity with MDR/IVDR requirements, preparing technical documentation, managing QMS and audits, or acting in a PRRC capacity either internally or on behalf of clients.

• Price

  EUR 345, including course material and certificate