Medical devices
- Published: December 2, 2019
- Last updated: June 28, 2022
Medical devices and medical products for in vitro diagnostics is regulated by two separate EU regulations, valid in the EU and the European Economic Area (EEA).
Since 26 May 2022 the EU regulation 2017/746 on medical devices for in vitro diagnostics, also called IVDR applies.
Since 26 May 2021 the EU regulation 2017/745 on medical devices, also called MDR applies.