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EC MDCG: Med Dev Guidance on Significant Changes regarding the Transitional Provision MDR

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:

  1. there is a change in the design or intended purpose, and

  2. 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.


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