Seminar: Responsible person for regulatory compliance according to MDR / IVDR

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Calendar
When:
2. October 2025 @ 09:52 – 10:52
2025-10-02T09:52:00+02:00
2025-10-02T10:52:00+02:00
Gesundheitswesen IVD Labors Medizintechnik Qualitätsmanagement Regulatory Affairs

Every manufacturer of medical devices must appoint at least one responsible person who is familiar with the provisions of the new EU regulation and monitors compliance. Get the necessary knowledge about the areas of responsibility with this seminar!

What are my responsibilities as the person in charge? How do I plan for long-term compliance with these requirements?

In this seminar, in addition to the regulatory framework, you will receive many practical tips and learn how the requirements can best be implemented.

Participants

Basic knowledge of the MDR and / or IVDR would be ideal. The requirements for the role of the responsible person are precisely defined here: https: //medizinprodukteregister.at/PRRC

The seminar contents

  • Introduction
    – General, purpose, regulation, definitions
    – Legacy device, transitional provisions
  • Person responsible for regulatory compliance
    – Qualifications, responsibilities, availability
    – Liability
  • Technical documentation (Annex II):
    – structure incl. content
  • Technical documentation (Annex III):
    – Post-Market Surveillance System, Vigilance, Market surveillance
  • Conformity assessment (Annex IX, X, XI)
  • EU declaration of conformity (Annex IV)

Your trainer

Daniel Rubisoier, BSc, MSc, Conformity Assessment Procedure Specialist MDR, TÜV SÜD Product Service GmbH

Costs

  • Early booking (up to 4 weeks before the seminar): Euro 540,- (excl. VAT)
  • Standard (from 4 weeks before the seminar): Euro 610,- (excl. VAT)
  • incl. seminar documents as PDF and confirmation of participation
  • All discounts at a glance

Venue: ONLINE

All you need for our ONLINE seminars is a laptop with a camera and microphone. Our eLearning platform works on all operating systems in web browsers (e.g. Firefox, Safari or Chrome). You will receive the seminar documents and the link to the virtual seminar room by email in good time. The seminar will be interactive – similar to a face-to-face seminar: i.e. you can ask your questions to the lecturer, there will be exercises and also the opportunity to exchange ideas with the other participants.

Click here for your online registration!

For questions: office@encotec.at or +43 1 8863491