New regulations regarding medical devices for in vitro diagnostics
From 26 May 2022, EU Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) will be applied.
Medical devices in the EU are regulated in two categories that follow different regulations, which means that medical devices for in vitro diagnostics (IVD) have their own regulations.
The content of the English pages of clinical studies step by step / special rules for medical devices here on the website is being updated and will be updated accordingly as soon as possible.
At the Swedish Medical Products Agency, you can find information about performance studies for IVD products External link.