Is CE marking required for internally used medical software provided as a service?

Question

Our company provides EEG analysis services to psychiatric hospitals. We have developed proprietary software to support this analysis, but the software is only used internally by our own staff and is not distributed or sold to customers. We are ISO 13485 certified and were planning to CE mark our software as a Class IIa medical device.
Given that we do not supply the software itself to customers, but only provide analysis services using the software, is CE marking legally required under the MDR? Where can I find more detailed information or guidance on this scenario?
For reference, the MDR defines 'making available on the market' as any supply of a device for distribution, consumption or use on the Union market in the course of a commercial activity, whether for payment or free of charge.

Dr. Oliver Eidel · Accepted Answer

This is a nuanced issue under the MDR. If your software is only used internally by your staff and is not provided to hospitals, you are not technically 'making available on the market' in the sense of supplying the device itself. However, Article 1.1 MDR also covers 'putting into service' which could be relevant if you are using the device to provide a commercial service.
There is an exemption in Article 5(5) for devices manufactured and used only within health institutions. This might apply if your company qualifies as a health institution (which can sometimes include private labs and clinics, but the definition can vary by country). If not, Article 6(2) on distance sales may require regular CE marking since you are providing a commercial service.
It's important to check local regulations and guidance, such as MDCG 2023-1, and whether your national competent authority considers your organization a health institution. If you do not qualify, you will likely need CE marking even if the software is only used internally but forms the basis of a commercial service. Consulting with a specialized lawyer or your national competent authority is highly recommended for a definitive answer.

Answer

From my perspective, the most important factor is the intended use of your software. If it clearly serves a medical purpose—such as aiding in diagnosis, monitoring, or influencing treatment decisions—then it's hard to argue it's outside the MDR, even if only used internally. General-purpose tools (like Excel) are different. But for software processing and analyzing EEG/ECG data to support medical decisions, the MDR would likely apply.
Whether or not you supply the software, the fact that you're using it to provide a medical service probably means it falls under MDR scope. Local law may also play a role, so it's worth checking with your competent authority.

Is CE marking required for internally used medical software provided as a service?

2 Answers

Keep reading

Is CE marking required for internally used EEG analysis software provided as a service to hospitals?

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

In-House Devices Under The MDR