The Service is positioned as Clinical Decision Support Software outside the definition of a medical device under section 520(o)(1)(E) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The Service: (i) displays / analyzes medical information; (ii) supports the clinician's recommendations; (iii) enables the clinician to independently review the basis for the recommendation; (iv) is not intended to acquire, process, or analyze a medical image / signal. Not 510(k) cleared. Not De Novo authorized. Not PMA approved.
The Service is not CE-marked as a medical device. Functions that could be construed as medical-device software under Art. 2(1) MDR (e.g. calculated PHQ-9 score, drug-interaction alerts) are operated as information presentation only, not as autonomous clinical decisions. Clinics electing to rely on Service output for clinical decisions assume responsibility under MDR Art. 2(1) + national medical-practice law.
The Service is not registered with the Medicines and Healthcare products Regulatory Agency (MHRA) as a UKCA-marked medical device. Same positioning as for EU MDR above. UK clinics: see MHRA guidance on “Software and AI as a Medical Device Change Programme”.
Not registered as a medical device under the German Medizinprodukte-Durchführungsgesetz (MPDG). Clinical decisions remain with the treating physician.
The Service is not registered with the Agence nationale de sécurité du médicament et des produits de santé (ANSM) as a medical device within the meaning of art. R. 5211-1 of the French Public Health Code (CSP).
The Service is not registered with the Ministero della Salute — Direzione Generale dei Dispositivi Medici (Banca Dati / Repertorio Dispositivi Medici) as a medical device pursuant to Regulation (EU) 2017/745 (MDR) and D.Lgs. 137/2022 (national adaptation).
The Service is not registered with the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) as a medical device (producto sanitario) under Real Decreto 1591/2009.
The Service is not entered in the Medical Equipment Register (פנקס הציוד הרפואי) of the Israeli Ministry of Health (AMAR Division) as medical equipment under the Medical Equipment Law, 5772-2012 (חוק ציוד רפואי, התשע"ב-2012) and the regulations issued under it, because it is neither a device nor software required to operate a device (section 1 of that Law).
Output of the Service is provided AS-IS. No fitness for a particular medical purpose is warranted. The clinician shall independently verify each suggestion before acting on it. See EULA for full limitation of liability.
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