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This one-day intensive course aims to provide a better understanding of IVD performance assessment and its practical implementation under Regulation (EU) 2017/746 (IVDR).
A performance evaluation of IVDs was already required under the European Directive on IVDs (IVDD). However, the IVD Regulation (IVDR) now comes up with more specific and stricter requirements for performance evaluation and, above all, its documentation.
This seminar provides a practice-oriented guide that:
- explains the concept of performance evaluation within the framework of the IVDR
- focuses on the interaction of the necessary elements of the performance evaluation and the requirements for this
- Different performance evaluation scenarios for different IVD product types are highlighted with the help of current MDCG guidance
- conveys whether and how you can incorporate old performance data into the performance evaluation and
- addresses the peculiarities of the performance evaluation of class D products (common specifications, expert panels)
topic overview
- Concept of performance evaluation according to IVDR, including best practices
- Elements of the performance evaluation - e.g. clinical evidence, clinical benefit, clinical performance, state of the art
- MDCG guidance on performance evaluation, different scenarios, different product types
- Use of "old" performance data, "other studies"
- Peculiarities of class D products: Common Specifications, Expert Panels
target group
Manufacturers of medical devices that are intended for reprocessing and reuse or that have to be cleaned, disinfected and/or sterilized before they are used for the first time, as well as employees from development, product management, quality assurance, regulatory affairs and marketing.
previous knowledge
Knowledge of the basic requirements for medical devices is helpful.
KONTAKT:
MedicalMountains GmbH
