Article 15 of MDR 2017/745 and IVDR 2017/746 requires manufacturers and EU authorized representatives to appoint a "person responsible for compliance with the regulatory provisions" from May 26, 2021 (MDR) or from May 26, 2022 (IVDR). determine. This person is also called:

  • "Responsible Person" VP
  • "Person responsible for regulatory compliance", PRRC
  • "Qualified Person" (based on the pharmaceutical industry)

The responsible person replaces the safety officer for medical devices (SIB). However, the tasks and area of responsibility of the responsible person (VP) go far beyond those of the safety officer. Similar to the qualified person in the pharmaceutical sector, the VP is personally responsible for the conformity of the medical devices supplied, from development to production and release.

Goals

In this seminar, participants will learn:

  • Tasks and responsibilities of the responsible person
  • Detailed design and interpretation of Article 15 MDR / IVDR
  • Transitional regulation for manufacturers of "legacy products" according to MDCG 2021-25
  • Necessary prerequisites – expertise of this person
  • Tasks of the responsible person at the EU representative
  • Advantages and disadvantages of dividing responsibility between several people
  • Advantages and disadvantages of an internal or external responsible person
  • Effects on the organization and the QM system
  • Concrete possibilities of implementation in the QM system
  • To what extent the CP is liable
  • Permissibility of delegation of tasks
  • dealing with conflicts

This seminar forms the basis of the training to become a responsible person. We recommend further seminars in order to be able to fill out the extensive area of responsibility competently:

  • Seminar on the basics of the MDR / Seminar on the basics of the IVDR
  • Seminar on ISO 13485

KONTAKT:
Online Seminar

 

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