We’re using semantic versioning (semver) for assigning version numbers to our software which we want to certify as a medical device. For future updates, We’re currently trying to understand what constitutes a significant change. We’re wondering: Semver structures the version number as
major.minor.patch. Does that mean that we can only increment the
patchnumber as otherwise we’d be making a significant change and would have to get approval of our notified body?
No. You can increment whatever number you want. It depends entirely on the content of the change, not your version number. See my answer on significant changes.
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.