2022-05

On May 4, 2022, the MDCG published the 2022-6 Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR.

This guidance document is intended to provide clarification on the concept of ‘significant changes in the design and intended purpose’ under IVDR Article 110(3). It concerns manufacturers of devices that are compliant with Directive 98/79/EC and that are placed on the market or put into service after 26 May 2022 during the transition period in accordance with Article 110(3) IVDR, irrespective of whether or not those devices required notified body involvement under the IVDD.

The document can be downloaded in our library

Source: European Commission