|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.