EU IVDR 2017/746 PERFORMANCE EVALUATION TRAINING 31.05./30.06./30.08./30.09./29.10./30.11./15.12.2021
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The in-vitro diagnostic medical device regulation (IVDR) 2017/746 was published in 2017. It applies from May 2022. It contains new, detailed requirements on Performance Evaluation, which trigger activities for the demonstration of conformity prior to launch as well as for continuous performance follow-up after launch. All your claims must be backed up with clinical data. This training will provide you with the needed information in order to achieve a good performance evaluation in reference to the EU IVDR including the performance characteristics, the requirements, scientific validity and others. Attendees will benefit from an extensive view of the performance evaluation, its methodology and requirements as well as an understanding of its importance.
• Opening remarks
• Introduction to IVDR
• GSPR 9: Performance Characteristics
• Performance Evaluation Requirements
• Scientific Validity
• Analytical Performance
• Clinical Performance
• Performance Studies
• Post-Market Performance Evaluation
• Eudamed Module on Clinical Studies
• Q&A session
• Closing remarks
- Start 02:00 PM – End 06:00 PM. Attendees are recommended to login 15 min in advance.
In order to keep the training interactive, the exact content schedule cannot be provided.
Certification:Personal Certificate will be provided in PDF
Presentation:Presentation will be provided in PDF