The amending regulation which extends the transitional provisions of the IVD Regulation has become EU law and comes into force from today. This is immediately applicable in all member states, and will allow for further preparation time for companies depending on device classification.
Regulation (EU) 2022/112 extends the IVDR transitional periods, allowing most devices with their EC Declaration of Conformity under the IVD Directive to be placed on the market and or put into service for an additional timeframe of 3-6 years depending on their appropriate risk class under the IVDR.
A sell-off provision is provided for devices which have already entered the supply chain before the end of their transitional period. Certain requirements under IVDR Article 5.5 are also postponed for health institutions (laboratories) which manufacture and use ‘in house assays’.
**Please note that the 26 May 2022 date of application of the IVD Regulation remains unchanged.
Devices which are Class A non-sterile must have obtained CE marking under the IVDR from the date of application. New’ devices will need CE-marking under the IVDR after date of application.
The full amended regulation is available for your reference here.