In brief
On 20 December 2021, the European Parliament and the Council adopted a Regulation amending the transitional provisions set forth in Regulation EU 2017/746 on in vitro diagnostic medical devices (“IVDR”).
In particular, the amending Regulation provides for the introduction of longer transitional periods with respect both to the validity of the certificates issued by notified bodies in accordance with Directive 98/79/EC (“IVDD”) and for the placing on the market and putting into service of in vitro diagnostic medical devices pursuant to the IVDD. The duration of the extension of the transitional period depends on several factors, including whether the device holds a certificate issued in accordance with the IVDD, whether the conformity assessment procedure under the IVDR requires the intervention of a notified body, and the specific risk class to which the device in question belongs.
However, the safety and performance requirements set forth in the IVDR remain unchanged, as well as the intended date of its application, which is still 26 May 2022.
