Clinical evidence requirements according to the IVDR 2017/746: practical tools and references for underpinning clinical evidence of IVD-MDs.
Fiche publication
Date publication
mars 2023
Journal
Clinical chemistry and laboratory medicine
Auteurs
Membres identifiés du Cancéropôle Est :
Dr PAZART Lionel
Tous les auteurs :
Charrière K, Pazart L
Lien Pubmed
Résumé
In May 2022, the European Regulation 2017/746 (IVDR) came into force. It changes the approach of medical devices (IVD-MDs) for industry and institutions. It reinforces the clinical evidence requirements to improve performance, safety and transparency. Despite extended transition periods and existing guides, IVDR remains difficult to interpret and bringing devices into compliance requires efforts. The generation of clinical evidence is essential to demonstrate compliance with IVDR, and encompasses scientific validity, analytical performance and clinical performance. It is required to demonstrate, per intended use in the target population and clinical care pathway, IVD-MDs clinical performance (compared to a predefined clinical performance). Thus, there is a need for IVD-manufacturers and end-users in health care institutions, to obtain guidance on how to generate this clinical evidence. This article aims industrials and clinicians to identify key steps imposed by the IVDR for bringing IVD-MDs to the EU-market. We propose a general view of performance evaluation requirements for IVD-MDs and provide key references, including how to establish study design that will enable to document clinical performance of existing, refined or emerging medical tests. Finally, we propose a roadmap to address the relevant questions and studies in relation to the documents requested in the IVDR.
Mots clés
2017/746 IVDR, analytical performance, clinical evidence, clinical performance, in vitro diagnostic, performance evaluation
Référence
Clin Chem Lab Med. 2023 03 15;: