The IVDR

The IVDR (Regulation (EU) 2017/746 on in vitro diagnostic medical devices) will have major consequences for diagnostic laboratories. Timely preparation will be key to guarantee continuity of diagnostics after full application of the IVDR on May 26, 2022.

To support the >115 European diagnostic laboratories in its networks, ESLHO provides them with information on the IVDR, the ongoing implementation of this regulation, and how to prepare for the date of full application. Special attention is given to the diagnostic fields of the networks: hematology, hemato-pathology and immunology. As early as March 2018, ESLHO organized an informative symposium on the IVDR for all participants of the ESLHO networks in Leiden, the Netherlands. This was followed by lectures on the IVDR during the ESLHO symposia in 2018 and 2019, and a half-day webinar with lectures from different IVDR experts in 2020. The 10th ESLHO Symposium (11-12 November 2021) will start off with a half-day workshop on the IVDR.

In parallel, ESLHO tries to support the implementation of the IVDR by participation in and contribution to IVDR initiatives from the European Hematology Association (EHA) and the BioMed Alliance.

On this web page, ESLHO aims to collect useful information on the IVDR for diagnostic laboratories. This includes information in the form of Questions and Answers, and a list of useful resources.

ESLHO believes that collaboration is of vital importance in the process of facilitating optimal diagnostic healthcare under the IVDR. National and EU authorities can be supported in the IVDR implementation process by providing relevant input and raising concerns. When preparing for the IVDR, diagnostic laboratories can share information and discuss best practices. Collective development, standardization and validation of new diagnostic tests results in high-quality, multicenter-validated tests. Finally, laboratories can contribute to safe and effective CE-IVDs by performing performance studies in collaboration with manufacturers. Even though some of these activities can be performed on an individual basis, collective action is associated with a higher potential for visibility, quality and synergy, and is bound to have the greatest impact.