When new diagnostioc methods appear at the market it is important that a proper validation study is published, including performance characteristics of the biomarker measured in accordance with the new InVitro Diagnostic Medical Device Regulation (IVDR) by the European Union (EU) [1]. ECAT contributed to a commentary in the Journal of Thrombosis and Haemostasis in which the importance of the publication of such validation studies has been emphasized.
J Thromb Haemost, 2025; 23: 2107-2111.
This is publication can be approached via the following link: https://www.jthjournal.org/article/S1538-7836(25)00217-X/fulltext
[1] European Union. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746