The conditions that are set out in Article 120 (3) of the MDR include, among others, that legacy devices must continue to comply with the AIMDD/MDD, as applicable, and that there are no significant changes in the design or intended purpose of the device. The latter criteria could be considered as quite vague and could be open for interpretation, therefore, it is important for manufacturers and notified bodies to have a clear and unified understanding as to what changes to design or intended purpose would be considered ‘significant’. This in turn will help them to verify that no significant changes to the design have been made and they meet the criteria. The document provides detailed explanations of what is considered to be a significant change in the design and intended purpose in relation to Article 120 (3) of the MDR, examples of such changes, as well as flowcharts to help manufacturers determine if their change can be considered a significant change.
When compared to the initial release of MDCG 2020-3, one can note that there have been adjustments all over the document to align it to Regulation (EU) 2023/607 and guidance MDCG 2022-2.
The document can be accessed using the following link.
