In vitro diagnostic medical devices (IVDs) are tests used on biological samples to determine a person's health status. There is a broad range of IVDs. Some examples are self-tests for pregnancy, COVID-19 tests, cancer genetic tests, or high-throughput testing of blood donations for infections such as HIV, performed in clinical laboratories.
Regulation (EU) 2017/746 on in vitro diagnostic medical devices has been applied since 26 May 2022 and significantly reinforces the regulatory framework for these medical tests.
Further information on In Vitro Diagnostics (IVDs).
