The first version of MDCG 2020-3 on significant changes regarding the transitional provisions under Article 120(3) MDR takes into account the experience gained with the application of the original version so far, is aligned with the equivalent guidance for IVDs, MDCG 2020-6, and is adjusted to Regulation (EU) 2023/607.
According to Article 120(3) of the MDR, legacy devices must continue to comply with the AIMDD/MDD and there are no significant changes in the design or intended purpose of the device. Therefore, it is crucial for manufacturers and notified bodies to clearly understand what changes to design or intended purpose would be considered ‘significant’.
This guidance aims to clarify the concept of ‘significant changes in the design and intended purpose’ under Article 120(3c) of the MDR. It concerns manufacturers of legacy devices.
This guidance also provides several flowcharts in order to facilitate a harmonised judgment of the significance of a change. The assessment of a proposed change using the main flowchart and any of the applicable sub-charts is intended to assist manufacturers, notified bodies and market surveillance authorities in deciding whether or not a change is to be considered significant, including:
Chart A: Changes in the intended purpose.
Charts B to E: Changes in the design.
For further details of the guidance, please consult the attachment.
MDCG 2020-3 Rev.1 - Guidance on significant changes regarding the transitional provision under Article 120 of the MDR