EU In Vitro Diagnostics Regulation (IVDR)

In 2017 the European Union (EU) decided that the system of registration, research and post-market surveillance in the field of in vitro diagnostics will change.

This is laid down in EU Regulation 2017/746, also known as the In Vitro Diagnostics Regulation (IVDR). From 26 May 2022, in vitro diagnostics must comply with new European rules.