The MDCG guidance document on significant changes under MDR Article 120(3) has been updated. MDCG 2020-3 Rev. 1 can be found: HERE
The Document was updated to:
- align to the equivalent IVDR guidance MDCG 2022-2,
- account for the extension to the MDR transitional provisions (EU 2023/607), and
- to take “into account the experience gained with the application of the original version so far”.
The scope of the document is related to significant changes to a device design or intended purpose as they relate to the MDR transitional provisions. All other types of changes are out of the scope of Article 120(3) MDR.