IVD Performance Evaluation & Performance Studies
IVD Performance Evaluation & Performance Studies
Scientifically Sound and Traceable Performance Evidence
For in vitro diagnostic medical devices, scientific validity, analytical performance, and clinical performance are essential components of regulatory evaluation.
Avary Consulting supports IVD manufacturers in planning, coordinating, and evaluating appropriate performance evidence in accordance with Article 56 and Annex XIII of Regulation (EU) 2017/746 (IVDR).
For performance studies, we also consider applicable IVDR requirements, particularly Article 57 et seq. and Annex XIV, as well as ISO 20916, where relevant.
Our services include:
- Development of performance evaluation strategies
- Support for Performance Evaluation Plans (PEP)
- Support for Performance Evaluation Reports (PER)
- Assessment of analytical and clinical performance evidence
- Identification of evidence and documentation gaps
- Coordination of external laboratory and study activities
- Support for regulatory requirements related to performance studies
Our Recommendation for IVD Manufacturers: Align scientific validity, analytical performance, and clinical performance with the product’s intended purpose at an early stage.