Intended purpose and regulatory classification
As of: 27 August 2026
This is a translation. The German version (Zweckbestimmung) is authoritative.
Whether software is a medical device or a high-risk AI system depends, among other things, on the intended purpose defined by the manufacturer or provider — as it follows from product information, instructions for use, advertising and sales statements and, where applicable, the technical documentation. This classification can be reviewed by authorities and, in the event of a dispute, by courts. It cannot be determined by a disclaimer. That is why we disclose it here.
What Psymira is intended for
Psymira is intended as practice and documentation software for psychotherapy practices. AI functions support, among other things, transcription, structuring, summarisation and the creation of draft texts. The results are intended for professional review by the responsible user.
What Psymira is not intended for
Psymira is not intended for diagnosis, prognosis, treatment, therapy decisions or the automated assessment of clinical risks. In particular, Psymira does not perform automated suicide risk assessment, medical triage or biometric emotion recognition.
Regulatory classification
On the basis of this intended purpose and the current scope of functions, Psymira is classified as software that is not a medical device and as an AI system that does not fall under the high-risk categories of Art. 6 of the EU AI Act.
When this classification is reviewed
This classification is reviewed if the scope of functions, the intended purpose or the regulatory framework change significantly.