Regulation 2022/112 Published, Rolling out IVDR Compliance Dates

This amendment delays some aspects of the IVDR, including rolling out compliance dates based on device risk class.

The IVDR is not delayed outright (like the MDR was). Instead, the EU institutes a longer transition period for most IVDD legacy devices; exact dates depend on the device classification.

Please see the Commission’s Q&A for more information on the IVDR roll-out.