The one from mir|detect developed M371-Test for the detection and monitoring of testicular germ cell tumours has been approved in accordance with Regulation 2017/746 IVDR since April 2024, making it one of the first IVDR certificates in the EU.
The new EU regulation significantly tightens the regulatory requirements compared to Directive 98/79/EC IVDD and ensures greater safety for patients and users in the use of in-vitro diagnostics.
With the IVDR certification of the M371-Test ensures that the scientific validity as well as the analytical and clinical performance has been extensively tested and confirmed by an independent body.