EU MDR 2017/745

73Health operates within the European regulatory framework established under EU MDR 2017/745 concerning medical devices and healthcare technologies. eEVA is a physician-led remote diagnostics and telehealth platform intended to enable remote clinical examinations and physician-led diagnostics using connected medical devices. The platform combines secure real-time communication, transmission and display of medical device data, telehealth workflows, and interoperability between healthcare professionals, patients, and connected medical devices.

The eEVA software itself does not perform diagnosis, automated interpretation, clinical decision support, treatment recommendations, automated medical analysis, disease detection, patient prioritization, or autonomous clinical decision-making. The software does not replace the clinical judgment of healthcare professionals. All clinical judgment, diagnosis, interpretation of findings, patient assessment, and treatment decisions remain solely the responsibility of qualified healthcare professionals.

Healthcare professionals use eEVA during remote consultations and examinations in combination with connected medical devices. These connected medical devices generate the physiological and clinical measurement data used during the consultation, and eEVA securely transmits and displays this information in real time, but does not modify, alter, interpret, or clinically analyze the medical data. Connected medical devices remain regulated separately by their respective manufacturers under applicable regulatory frameworks, and eEVA does not alter the intended purpose, medical functionality, or regulatory classification of connected medical devices.

73Health operates as a registered System and Procedure Pack Producer under EU MDR 2017/745 and maintains applicable economic operator responsibilities, including importer and distributor roles where applicable. The eEVA platform is intended to support physician-led remote diagnostics, remote clinical examinations, healthcare communication workflows, remote consultations, real-time transmission of medical device information, and interoperability between healthcare professionals and connected medical devices.

The platform is not intended to autonomously diagnose diseases or conditions, provide automated medical interpretation, perform clinical decision support, replace physician decision-making, generate treatment recommendations, perform automated patient triage or prioritization, provide autonomous AI-based diagnostics, or modify medical device measurement data.

73Health uses terminology such as remote diagnostics, remote clinical examinations, physician-led diagnostics, telehealth diagnostics, and connected medical devices to describe the real healthcare environment in which healthcare professionals use the platform. These terms refer to healthcare professionals performing clinical and diagnostic work remotely using connected medical devices and telehealth infrastructure. They do not mean that the eEVA software itself autonomously performs diagnosis, interpretation, or clinical decision-making.

73Health’s regulatory positioning and Software as a Medical Device (SaMD) assessment have been reviewed together with regulatory experts from Cencora Pharmalex specializing in EU MDR medical device and software regulation. The assessment has included evaluation of the intended purpose, software functionality, clinical workflow, device interoperability architecture, and applicability of MDR and MDCG guidance related to software-based healthcare technologies.

73Health continuously evaluates its technologies, workflows, and future product development activities in relation to applicable European regulatory requirements, including MDR guidance concerning software, interoperability, connected medical devices, and future healthcare AI technologies. Healthcare professionals remain solely responsible for all clinical decisions, eEVA does not autonomously generate medical conclusions, eEVA does not replace physician judgment, connected medical devices remain separately regulated, and the platform enables physician-led remote diagnostics through secure real-time communication and interoperability infrastructure. Future AI-related technologies are evaluated separately under applicable regulatory pathways before deployment in clinical use.