MDCG 2021-4 Rev 1 : Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746 – April 2021

This guide in the form of questions and answers provides indications on how to apply the provisions of the regulation relating to the conformity assessment of class D IVDs. It specifies how the prerogatives of the expert groups and the EURLs (European Union Reference Laboratories) are to be applied in this area, particularly during the transition period.