MDCG 2021-22 Rev. 1 : Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746 – August 2021

7 Sep 2021 | All the News, MDCG

Theme Expert panel consultation referred to in article 48(6) of Regulation (EU) 2017/746
Target Audience Notified bodies – Manufacturers
Products concerned IVD
Documents mentioned

IVDR (EU) 2017/746

Directive 98/79/EC

 

This MDCG guide sets out criteria to be established in order to assist the notified body in determining whether to consult the expert group on the performance assessment report for Class D IVD in accordance with Article 48(6) of Regulation (EU) 2017/746.