New MDCG Q&A on IVDR Class D Provisions 📰

New MDCG Q&A on IVDR Class D Provisions 📰

The Medical Device Coordination Group (#MDGC) has published a new guidance document, “MDCG 2021-4 – Application of Transitional provisions for Certification of Class D In Vitro Diagnostic Medical Devices according to Regulation (EU) 2017/746”.

The document outlines key questions for notified bodies and IVD manufacturers regarding the transition period, due dates for notification of NBs, device analysis, etc.

Questions Include

(1)    During the transition, may NBs accept applications for certification of class D IVDs, and issue the corresponding certificates, if the IVD expert panel is not yet operational?

(2)    For applicable devices when must the NB submit the performance evaluation report of the manufacturer to the expert panel?

(3)    How should the NB determine whether the device will have to undergo consultation of the expert panel?

(4)    When can the NB expect to receive the views of the expert panel?

(5)    During the transition, may NBs applications for certification of a class D IVD, and issue the corresponding certificate(s), if an EURL is not designated for that device?

(6)    What will happen to devices certified under the IVDR in the absence of an EURL if an EURL is designated for the corresponding scope at a later time point?

🔍 See the pdf here : https://bit.ly/3ndmFZV