MDR: MDCG 2022-6 - Guidance on Significant Changes Regarding the Transitional Provision under Article 110(3) of the IVDR – June, 2022

• 2022-06-29 02:14:40

MDCG 2022-6 provides clarifications on the concept of ‘significant changes in the design and intended purposes’ under IVDR Article 110(3). It concerns manufacturers of devices that are compliant with Directive 98/79/EC (IVDD) and that are placed on the market or put into service after 26th May 2022 during the transition period.

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