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Updated September 30, 2021

How Do SemVer Versions Map to Significant Changes for a Medical Device?

Dr. Oliver Eidel
Significant Change

Question

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 patch number as otherwise we’d be making a significant change and would have to get approval of our notified body?

Short Answer

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.

Long Answer

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.

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I work as a regulatory consultant for Healthcare software startups. I try to publish all my knowledge here so that startups can certify their medical devices themselves in the future.

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