The MDR 2017/745 and the IVDR 2017/746 require in Article 15 that all manufacturers from May 26th, 2021 (MDR) or from May 26th, 2022 (IVDR) appoint a "person responsible for compliance with the regulatory provisions". 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 approval.

goals

In this seminar the participants get to know:

  • Tasks and responsibilities of the responsible person
  • Detailed interpretation and interpretation of Article 15 MDR / IVDR
  • Necessary prerequisites - expertise of this person
  • Advantages and disadvantages of sharing responsibility among several people
  • Advantages and disadvantages of an internal or external responsible person
  • Effects on the organization and the QM system
  • Concrete options for implementation in the QM system
  • To what extent the CP is liable
  • Admissibility 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 in the extensive area of responsibility competently:

KONTAKT:
Online Seminar

 

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