In vitro diagnostic (IVD) devices – such as new tumor markers or tests to detect SARS-CoV2 – are also facing more stringent requirements to demonstrate their utility. REGULATION (EU) 2017/746 on in vitro diagnostic (IVD) devices will soon apply. This also tightens the requirements for performance studies, i.e. the clinical studies that must be carried out to demonstrate the basic safety and performance requirements.
Just in time for Easter, we refreshed our knowledge of in-vitro diagnostics at TÜV Süd and had ourselves certified. We are ready for the new requirements!
We wish all of us a happy Easter and all our loved ones good health for the coming months.