The European Commission’s Medical Device Coordination Group (MDCG) released updated guidance "Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD".
The purpose of this guidance document is to clarify the meaning of 'significant changes in the design and intended purpose' under Article 120(3c), point (b) of the MDR.
A "legacy device" is a medical device that was legally placed on the market prior to the implementation of the Medical Devices Regulation (MDR) in the European Union (EU).
A significant change in the design or intended purpose consists of two cumulative elements:
there is a change in the design or intended purpose, and
the change is significant.
It is the manufacturer's responsibility to provide evidence and justification that a change does not impair the design or intended purpose of the device, or, if it does, that it is non-significant, which should be assessed individually.
Some examples of changes that would be considered significant include changes to the devices:
Sterilization process
Material composition or formulation
Design specifications or drawings
Electrical or mechanical components
Clinical performance or intended use
To know more about this guidance click this LINK.