These updated transition periods mean that organisations do not need to conform to the full scope of the IVDR dependent on the risk classification of their product, but also ‘freezes’ the product as significant changes cannot be made to the product during this period. Where significant changes are made, the product must conform to the full scope of the IVDR that applies to it.
The guidance on significant changes was published by the MDCG on 4 May, and provides this much needed clarity on Article 110(3).
As expected, changes made that do not affect the design or the intended purpose of the device are not included in the scope, and so can continue to be made.
The document provides flow diagrams to determine whether a change is significant or not. If in doubt, manufacturers are encouraged to request a decision from their notified body.
The following are not considered significant (not an exhaustive list – see guidance):
- Changes related to corrective actions which have been assessed and accepted by the competent authority
- Corrections of spelling or editorial errors
- IFU or labelling updates where they are required by a law other than the IVDR
- Where the intended purpose is being limited (i.e. restricting the specimen type)
- Changes to the design that do not impact the device’s operating principle and do not adversely affect the safety and performance of the device (i.e. change in incubation times)
- Software changes:
o Correction of an error that does not post a safety or performance risk
o Third party updates or upgrades
o Security fixes
o Changes to the user interface relating to appearance and to enhance the interface
- Changes of an ingredient or material that is not essential for the operation of the device and do not adversely affect safety or performance of the device
- Sterilisation cycle parameter changes that are under the approved QMS
- Shelf-life changes that have been validated by protocols approved by the notified body
Alternatively, the following are considered to be significant (not an exhaustive list – see guidance):
- Where the intended purpose is being extended (i.e. addition of a specimen type)
- Other major changes of the intended purpose (i.e. change of intended use)
- Changes to the design that impact the device’s operating principle and adversely affect the safety and performance of the device (i.e. reduction of sensitivity values)
- Software changes:
o Operating system changes
o Algorithm, database structure or architecture modifications
o Addition of new databases that is used to compare genetic assay results
o User input being replaced with closed loop algorithm
o Format changes to medical data
- Changes of an ingredient or material that is essential for the operation of the device and do not adversely affect safety or performance of the device
- Change of sterilisation method
- Design or packaging changes that adversely affect sterility assurance or effectiveness of sterilisation
We recommend you review this guidance thoroughly and contact your notified body in cases where you are unsure whether a change is considered to be significant.