The EU MDCG have published guidance document MDCG 2022-6 to provide clarifications on significant changes as mentioned in Article 110 of the EU IVDR. Manufacturers using this Article in order to continue placing their legacy products on the EU market will know that understanding the meaning of a significant change will be key in continually complying with Article 110 and keeping within the required boundaries.
In order to benefit from the extended transitional provisions of Article 110(3) a device may not undergo a significant change in design and intended purpose following the Date of Application, 26 May 2022. This means that there may be changes made to the design or intended purpose, however, these must not be considered significant. Other changes which do not have an impact on the design or intended purpose are considered outside of the scope of Article 110(3) and will thus be allowed.
Any change made to the device which influences the design or intended purpose of the device shall be recorded and a justification provided as to why these may not be considered as significant. The following changes may not be judged as significant:
- Changes of the manufacturer’s name, address or legal form, including a merger or acquisition involving the manufacturer.
- Changes in relation to the authorised representative.
- Relocation or addition of new manufacturing sites, including when it affects subcontractors or suppliers.
- Changing the supplier of a material, ingredient or component, provided the specifications of the new material, ingredient or component do not change.
- Adding or replacing a new material number for logistic reasons without changing the material.
- Changes to outer packaging (e.g. size, material, layout) that do not adversely affect the stability, sterility or microbiological state of the device.
- New process validation as part of manufacturing improvements or scale-up of manufacturing.
- Change in the QMS which do not have an impact on design or intended purpose.
MDCG 2022-6 provides a number of flowcharts which may be consulted to determine whether or not a change made to the design or intended purpose of the device may be considered significant or not.
