On May 25, 2017, the IVDR, the In Vitro Diagnostic Device Regulation, came into force. After the transition period has expired, all IVD manufacturers, notified bodies, distributors, EU representatives and importers of IVD medical devices must meet the requirements of the IVDR.

This seminar helps you to understand the extensive requirements of this EU regulation and to implement them in a targeted manner.

goals

The IVDR seminar builds on the MDR seminar, since essential contents of the IVDR are letter-identical to those of the MDR. Participation in the MDR seminar is therefore an important but not a mandatory requirement.

The IVDR training pursues the following learning objectives:

  • IVDR: Innovations overview and comparison with the MDR
    You will get a quick overview of the IVD-specific changes and learn which topics you need to address when converting to the IVDR.
  • Classification and conformity assessment procedure
    You will get to know the fundamentally changed classification rules. You will learn which conformity assessment procedures the IVDR offers and how they differ from those of the IVDD.
  • Basic safety and performance requirements
    You know the new requirements of the completely revised and expanded Appendix I, which you have to prove with the help of the technical documentation. You are familiar with the requirements for this documentation, which the IVDR formulates for the first time in a separate appendix.
  • The role of notified bodies under the IVDR
    You understand how you will have to work together with the Notified Body in the future in order to declare conformity with the IVDR for your products for the first time or again.
  • Revaluation of existing products
    You have an overview of how you can market your existing products under the IVDR even after May 26, 2022.
  • Clinical performance evaluation
    You know how to use analytical and clinical performance data and, if necessary, performance studies and scientific validity to create a performance evaluation report. The corresponding requirements have literally exploded.
  • Post-market surveillance
    You are familiar with the prescribed post-market activities and know how to carry out a Post Market Performance Follow-Up (PMPF) and create a Periodic Safety Update Report.

At the end of the seminar you will receive an implementation proposal with milestones and an activity plan for your personal IVDR implementation strategy.

This seminar not only provides you with comprehensive knowledge, but also the skills to revise your quality management system, in particular your processes and specification documents, so that you can develop your in-vitro diagnostics in compliance with IVDR, bring them onto the market and monitor them there.

KONTAKT:
Online Seminar

 

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