The Service is not registered with the Medicines and Healthcare products Regulatory Agency (MHRA) as a UKCA-marked medical device, and is not CE-marked under the transitional arrangements recognised in Great Britain. Functions that could be construed as software as a medical device (SaMD) — for example a calculated PHQ-9 score or drug-interaction alerts — are operated as information presentation only, for the treating clinician's independent review, not as autonomous clinical decisions. Clinics electing to rely on Service output for clinical decisions do so under their own professional responsibility. See the MHRA "Software and AI as a Medical Device Change Programme" and the current guidance on medical device software.
The Service is not CE-marked as a medical device. Functions that could be construed as medical-device software under Art. 2(1) MDR 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) and national medical-practice law.
The Service is positioned as Clinical Decision Support software outside the definition of a medical device per FDA Section 520(o)(1)(E) of the Federal Food, Drug, and Cosmetic Act. The Service: (i) displays / analyses 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 analyse a medical image / signal. Not 510(k) cleared. Not De Novo authorised. Not PMA approved.
The Service is not registered with the Israeli Ministry of Health / AMAR Division as a medical device under the Public Health Regulations (Medical Accessories).
The Service is not registered with the Ministero della Salute — Direzione Generale dei Dispositivi Medici as a medical device pursuant to Regulation (EU) 2017/745 (MDR) and D.Lgs. 137/2022.
The Service is not registered with the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) as a sanitary product under Real Decreto 1591/2009.
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 the full limitation of liability.
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