The IVD Regulation is amended to extend its transitional provisions

Posted on 02.02.2022

The transitional provisions of the IVD Regulation (EU) 2017/746 have been amended, following the publication of Regulation (EU) 2022/112 (link) in the Official Journal of the European Union. The amendment provides more time for IVDs to transition to the IVD Regulation and supports that those tests currently on the market can remain available to patients, laboratories, hospitals and healthcare professionals.

The amendment:

Maintains the date of application of the IVD Regulation of 26 May 2022;
Extends the transitional provisions for most IVDs already on the market, according to their risk class;
Provides additional transition time for most of the requirements pursuant to in-house assays.

The amending regulation entered into force on Friday, 28 January 2022.