Apart from properly documenting the change in your Change Management System, I would recommend utilizing the guidance in MDCG 2020-3, 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, to assess and justify the change to the device. A letter to file similar to those done for FDA could work as a good 'cover letter' for the technical file as the changes can be summarized and then linked directly to the change control record. I like the decision trees in MDCG 2020-3 as they can be included as part of the assessment to show that all areas were considered.
It should also be noted that, while the change may be determined to be non-significant, agreements with your NB could require notification of the change.
I recommend that you don't document them, sort-of.There is no requirement to document non-significant changes. The only requirement is to determine whether a change is significant as determined by your contract with your NB. In those case you need to submit the change to the NB before implementing it.A change to a device is a design change, so you should document it using your FDA QSR and EN ISO 13485:2016/A11:2020 design change process. If the change is non-significant, there is nothing else to do.The "sort of" part suggests you have a check list or decision tree to determine if the change is significant. Put the results in the design history file in the same manner you would document the decision that a change doesn't need a new 510(k).
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