Theme Transitional provisions – Conformity Assessment – EURL
Target Audience Manufacturers, Notified Bodies
Products concerned Class D IVD
Documents mentioned IVDR (EU) 2017/746


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.