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In the two-day seminar "Responsible person for regulatory provisions according to Art. 15 EU-MDR" two topics will be dealt with:

  • Designing the role of the Regulatory Responsible Person (PRRC)
  • Tools for the PRRC

In the area of shaping the role of the PRRC, the focus is on the following topics:

  • Obligations of the PRRC
  • Refreshing of the essential regulatory requirements and structures (including basic safety and performance requirements (GSLA), EU declaration of conformity, technical documentation, product registration (EUDAMED/Basis-UDI-DI/UDI))
  • Description of the obligations of the manufacturer and the notified bodies
  • Design of the PRRC in the company: Interfaces of the PRRC, PRRC in the context of the process landscape in the company

The topic of tools for the PRRC is about teaching the following topics:

  • Communication with notified bodies and relevant authorities
  • Monitoring of regulatory requirements

topic overview

  • Design of the PRRC according to MDR and IVDR in the company
  • Regulatory bases for the PRRC, including:
    • Obligations of the manufacturer / obligations of the notified bodies
    • GSLA / EU Declaration of Conformity
    • Product Registration
  • Communication with notified bodies and relevant authorities
  • Change management / reporting and actions / monitoring of regulatory requirements

target group

Persons who act as PRRC in the company or will act in the future.

previous knowledge

General prior knowledge in the field of medical devices.

KONTAKT:
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