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Is CE marking required for internally used EEG analysis software provided as a service to hospitals?
Anonymous
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2 comments
8 months ago
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
Accepted
2 answers
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