2021-05

Due to the lack of required regulatory infrastructure, the conformity assessments for class D IVD devices can not currently be completed under the IVD Regulation. Following the publication of MDCG 2021-4 ‘Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746 in April 2021’, Notified Bodies suggest an approach to performing conformity assessments of class D devices, in the absence of EU Reference Laboratories and consideration of the delay to the IVD Expert Panel becoming operational based on the issued guidance. Some outstanding questions remain and need to be urgently addressed by the Commission.

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Source: Team-NB