Non-significant change / significant change (of design or intended purpose)

Legacy devices with MDD or AIMDD certificates may stay on the market during the transition only if there are no significant changes in design or intended purpose. MDCG 2020-3 gives flowcharts to make that call, and a significant change ends the legacy status of the device.

A change is considered a non-significant change of design or intended purpose per Article 120(3c) point (b) MDR if the answer to every question in a sub-chart leads to “non-significant change” also when returning to the main chart. On the contrary, if any sub-chart delivers the result “significant change”, the change being assessed is a “significant change in design or intended purpose” according to the Article 120(3c), point (b) MDR.

MDCG 2020-3 Rev.1, Section 4.3.2, Significance of changes