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

Question

We are a startup providing EEG analysis services to psychiatric hospitals using software developed for our own internal use. We are ISO 13485 certified and initially planned to CE mark the software as Class IIa. However, we do not supply the software to hospitals; instead, we use it internally to deliver analysis results as a service. Is CE marking legally required in this context? Where can we find more authoritative information on this?

Our intended purpose is to assist in the display and analysis of physiological signals derived from EEG and ECG data. The intended users are specialists trained by our company, with the computed information ultimately intended for use by physicians.

We are based in Switzerland and would be exporting services to the EU. Any guidance or resources would be appreciated.

Dr. Oliver Eidel · Accepted Answer

This is a really interesting situation. Under the MDR (and IVDR), the main factor is whether the software is considered to have a medical purpose and if it is being made available on the market. If your company only uses the software internally and provides a service (hospitals only receive the results), you may not be considered to be placing the software on the market. However, you could still be considered to be 'putting into service,' which brings you under the scope of the MDR.

If your company can be considered a 'health institution' under Article 5(5) of the MDR, you might be exempt from full CE marking. The definition of 'health institution' can vary by country, so you should check local guidance and the MDCG 2023-1 document. If you do not qualify as a health institution, Article 6 (distance sales) may apply, and you would have to CE mark the device as usual.

In practice, many private labs are considered health institutions, but this is not universal across the EU. Since you are based in Switzerland and exporting services to the EU, you should also check if the relevant EU member state will recognize your company as a health institution. If not, regular CE marking would be required. Consulting a local competent authority or a specialized lawyer is highly recommended in your case.

Answer

My understanding is that if your software is only used internally and you don’t provide it to the hospitals, but only provide the results, it might not be considered as being placed on the market. However, the intended medical purpose could still bring it under MDR/IVDR, especially if it influences clinical decisions. You should check if you qualify as a health institution for possible exemptions, or else CE marking may still be required. Local competent authorities and MDCG guidance should clarify your specific case.

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

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