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

This seminar will help 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 the main contents of the IVDR are letter-identical with those of the MDR. Participation in the MDR seminar is therefore an important but not mandatory requirement.

IVDR training has the following learning objectives:

  • IVDR: Innovations Overview and comparison to the MDR
    You get a quick overview of the IVD-specific changes and learn which topics you have to tackle when switching to the IVDR.
  • Classification and conformity assessment procedures
    You will learn about 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 extended Annex I, which you have to prove with the help of the technical documentation. You know 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 with the Notified Body in the future 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 to market your existing products under the IVDR after May 26, 2022.
  • Clinical Performance Evaluation
    You know how to create a performance evaluation report based on analytical and clinical performance data and, if necessary, on the basis of performance studies and through scientific validity. The corresponding requirements have literally exploded.
  • Post-market surveillance
    You know 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 with the skills to revise your quality management system, in particular your processes and specification documents, so that you can develop your IVDR-compliant in-vitro diagnostics, place them on the market and monitor them there.

KONTAKT:
Online Seminar

 

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