Performance evaluation is an essential part of the life cycle of an IVD. It follows a well-defined and methodologically sound procedure and comprises evidence of scientific validity, analytical performance and clinical performance. The data and findings obtained from the evaluation of these elements form the clinical evidence for the product. We will gladly advise and support you competently and precisely in the pragmatic implementation of the current regulations and prepare an independent performance evaluation in accordance with EU Regulation 2017/746 for your in-vitro diagnostic product.
After publication on May 5, 2017, the new IVD Regulation (IVDR) came into effect on May 26, 2017. For IVDs already on the market, there is a transition period of five years, i.e. until May 26, 2022, to meet the requirements of the IVDR. IVD manufacturers must ensure that they are IVDR-compliant by the end of the transition period. Early action is important, as IVDR compliance means a considerable effort to ensure timely or continued access to the EU market.
In addition to the new risk-based classification system, the IVDR will also place higher demands on technical documentation in the future. Here, a stronger focus will be placed on market monitoring/vigilance and proof of clinical performance. A performance evaluation of the product is to be used to verify that the basic safety and performance requirements are met. The report on the performance evaluation is part of the technical documentation.
We will be happy to answer your questions about the independent performance evaluation. You can contact us at ivd@novineon.com
Downloads
The pdf of the Regulation (EU) 2017/746 in English here
The pdf of the Regulation (EU) 2017/746 in German here