When assessing (significant) changes, it’s all about what you’re changing, not what your new version number will look like. See the answer linked above.
Consider this thought experiment: Instead of semver, you use a versioning scheme which just has one integer number which is incremented. So the first release would be version 1
and the 25th release would be version 25
. There’s no way to tell which release contains “major” changes in the semver sense. But some of those changes might still have been significant in the context of a medical device.
So: Use whatever versioning scheme you want, increment the numbers however you like, but assess the content of your changes whether they’re significant.