Is EEG data considered a "specimen" under the IVDR?

Question

Is it possible to consider data as a "specimen" under the IVDR?
Specifically, our company analyzes EEG data samples in a similar fashion to how DNA analysis companies handle blood samples. The processes and intended purpose are very similar, except we use EEG data instead of biological specimens.
We aim to display EEG characteristics solely to provide information, without claiming clinical benefit (i.e., focusing on performance evaluation rather than clinical evaluation).
Most of the information we display is backed by clinical studies, but clinicians often request more data to better understand patients' physiological status.
I have not found an official IVDR definition of "specimen." Has anyone encountered guidance or experience relevant to this scenario?

Dr. Oliver Eidel · Accepted Answer

If you are analyzing genome sequence data, that counts as standalone software IVD under the IVDR, since your data originates from an IVD (the blood sample, in that case). For EEG data, the specimen would still be the original biological material (such as blood for DNA), not the data itself. The data is the result of the measurement, not the specimen.
So, under IVDR, data is not generally considered the specimen—it's the output of analyzing the specimen, which remains the biological material.

Is EEG data considered a "specimen" under the IVDR?

1 Answer

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