New MDCG Guidance documents released (August 2022)

On July 13th 2022, the Medical Device Coordination Group (MDCG) released a new guidance document. This latest release provides guidance to Member States and other relevant parties on the application of certain IVDR provisions during the absence of Eudamed. To that end, this guidance intends to describe harmonised administrative practices and alternative technical solutions for the exchange of information until Eudamed becomes fully functional (MDCG 2022-12).

MDCG 2022-12 – Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices)

The proposed practices and solutions aim to enable Member States and other relevant parties to meet their obligations under the IVDR effectively while minimising any potential additional burden on the parties concerned. This guidance addresses in particular cases where the exchange of information would be difficult, or even not possible, to achieve based on the corresponding provisions of Directive 98/79/EC. The proposed practices and solutions set out in this document do not affect the general obligations of the parties to comply with the applicable requirements under the IVDR.

What does this mean to you?

MDCG 2022-12 provides practices and solutions on how to deal with certain IVDR provisions during the absence of Eudamed.

Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.

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