Publication of the MDCG 2021-22 Guidance

The Medical Device Coordination Group has just published the MDCG 2021-22 guide regarding the clarification on “the 1st certification for this type of device” and the procedures to be followed by NBs in the context of the expert panel consultation referred to in Article 48, paragraph 6 of Regulation (EU) 2017/746.

For Class D devices, Article 48(6) of Regulation (EU) 2017/746 on in vitro diagnostic medical devices establishes the conditions to be applied by the Notified Body to determine whether it has to consult an expert panel on the performance evaluation report of the manufacturer.

These conditions are:

(1) the absence of common specifications for the Class D device in question,

AND

(2) where it is also the first certification for that type of device.

This guidance provides clarification of these conditions and the procedures to be followed by the Notified Body.

DOWNLOAD THE MDCG 2021-22 GUIDANCE