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Articles Questions

July 27, 2020

Machine Learning Software as a Medical Device: Can We Update Our Model?

Dr. Oliver Eidel


We’re developing machine learning - based software as a medical device. We’ve learned that once you’ve got a certified on the market, you need to get approval by your notified body before releasing significant changes. Now our question is: How does this relate to our machine learning model? Can we update it? Is that a significant change?

Short Answer

Notified bodies currently classify a machine learning model update as a significant change. You need to re-do your verification of your new model (e.g. do some testing with a test set and document the results). Active learning models which change their weights during deployment are currently not allowed.

Long Answer

Regulation and notified bodies are only slowly catching up with machine learning - based software. There’s no official standard or guidance so far (is that a good thing?) so my answer is entirely based on my experience with auditors.

An update of your machine learning model, i.e. an update of its weights, is seen as a significant change. This generally makes sense because it changes the “performance” of your medical device. You need to re-do the verification of your ML model and send that documentation (along with everything else) to your notified body.

Generally speaking, getting approval for this sort of change shouldn’t be hard: Your ML model architecture stays the same and the performance has probably improved - why else would you update the model?

If you change the architecture of your ML model, you may face more scrutiny but just be sure to prove that the decision made sense, your performance hasn’t gotten worse and you haven’t made the risk profile of your software worse.

On a slighty different note: You want to get your medical software certified under MDR but don't know where to start? No worries! That's why we built the Wizard. It's a self-guided video course which helps you create your documentation yourself. No prior knowledge required. You should check it out.

Or, if you're looking for the most awesome (in our opinion) eQMS software to manage your documentation, look no further. We've built Formwork, and it even has a free version!

If you're looking for human help, did you know that we also provide some limited consulting? It's limited because we are not many people. We guide startups from start to finish in their medical device compliance.

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Dr. Oliver Eidel

I'm a medical doctor, software engineer and regulatory dude. I'm also the founder of OpenRegulatory.

Through OpenRegulatory, I've helped 100+ companies with their medical device compliance. While it's also my job that we stay profitable, I try to dedicate a lot of my time towards writing free content like our articles and templates. Maybe that will make consulting unnecessary some day? :)

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