The transition period to the new in vitro diagnostic regulation (IVDR) in the EU will last till next 26 May, 2022. In order to inform device manufacturers, the European Commission´s Medical Device Coordination Group issued a Q&A including information on how to handle class D devices, the highest risk class, during the transition period.
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“According to Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR), as part of conformity assessment of class D in vitro diagnostic medical devices (IVDs), the manufacturer must submit an application to a notified body. In addition to the assessment by the notified body, under certain conditions particular elements may be reviewed by an expert panel and/or tested by an EU reference laboratory (EURL). The establishment of EURLs for a range of class D devices has been identified as an important priority by the Medical Device Coordination Group. The European Commission is preparing the implementing acts on tasks and criteria of the EURLs and fees they may levy, referred to in Article 100(8) of the IVDR, as well as the first call for applications to be submitted by the Member States. This document provides indications for how to apply the IVDR provisions related to expert panels and EURLs during the transition period, i.e. before 26 May 2022.”
MDCG 2021-4 Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746, April 2021
For more details, please see the document from the MDCG.
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