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What is my company's role under MDR when incorporating a CE-marked software medical device from another manufacturer into our non-medical app?

Anonymous · Published December 12, 2025 · 2 comments
I am planning to incorporate a CE-marked software solution (manufactured by another company) into our app, which itself is not a medical device. The software will be made directly available to our users via our app.
Under the Medical Device Regulation (MDR), what would be the regulatory role of my company (e.g., distributor)? Are there post-market obligations we would need to fulfill?

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Anonymous 6 months ago
Is your app not a medical device, but the incorporated software is a CE-marked medical device?
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Anonymous 6 months ago
Is the CE-marked solution a module within your app or a hosted service accessed by users?
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Discussion

2 Answers

Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
We were in a similar situation and the competent authorities defined our role as a distributor. If you are making the CE-marked software medical device directly available to users, you would likely be considered a distributor under MDR. This means you would have certain post-market surveillance obligations, such as ensuring the software is compliant, reporting incidents, and cooperating with the manufacturer and authorities as needed.

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Anonymous ·
If the incorporated solution is a module, acting as a distributor is usually the right approach. If it's a hosted service, you could make it clear to users that they're accessing a medical device from another manufacturer, providing information about the manufacturer and how to report complaints. This can affect user experience, but it clarifies responsibilities.

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