Guidance MDCG 2022-6 on significant changes regarding the transitional provision under Article 110(3) of the IVDR

The MDCG (Medical Device Coordination Group) has just published the Guidance MDCG 2022-6 which aim to provide clarification on the concept of “significant changes” in the design and intended purpose of the product under IVDR Article 110(3).

This document is an aid to identify significant changes to devices that are compliant with Directive 98/79/EC and that are placed on the market or put into service after May 26^th, 2022 and during the transition period in accordance with Article 110(3) IVDR, whether or not those devices required notified body involvement under the IVDD.

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