PRRC training

On February 28, 2023, we conducted a training for Persons responsible for regulatory compliance (PRRC) as defined in the Medical devices regulation (EU) 2017/745.

The training was attended by 15 participants from 8 companies.

The training covered the following topics:

• Competence of persons responsible for regulatory compliance (PRRC)
• Responsibilities and duties of the person responsible for regulatory compliance:
  • According to the Medical Devices Regulation (EU) 2017/745 (MDR)
  • According to the Regulation for in vitro diagnostic devices (EU) 2017/746 (IVDR)
  • Responsibilities and duties of PRRC with authorized representatives in the EU
• PRRC’s role in ensuring compliance of:
  • Products
  • Technical documentation
  • PMS process
  • Clinical trials
• MDCG guidelines and Team PRRC position papers
• Ethical issues and possible conflict of interest
• Responsibility of the PRRC under different jurisdictions (in different EU member states).

After the presentation, a valuable discussion took place.

For the second part of the year, we plan trainings on PMS, Vigilance, and Risk management.