MDCG 2021-22 : Clarification of First Certification for that type of device and corresponding procedures 📢

The #MDCG has published a document on “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”

This covers topics including:

-          What is the meaning of “the first certification for that type of device” in accordance with Article 48(6) of Regulation (EU) 2017/746?

-          What procedure should a notified body follow to determine whether a given certification is the first for that type of device?

-          How should the notified body indicate the type of device in its submission to the IVD expert panel?

-          What is the meaning of the phrase “where no CS are available” in Art 48(6)?

-          If a notified body identifies that a consultation of an expert panel is currently ongoing for that type of device, what should it do regarding the certification process?

🔗  Find the document here: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-22_en.pdf

#MDRG #mdrguide #IVDR #MDR #medicaldevices #ec