February 11, 2026 – Gosta AI Operating System has been officially registered as a medical device in the European Union’s EUDAMED database, in accordance with the EU Medical Device Regulation (MDR, EU 2017/745). This milestone makes Gosta the first AI assistant in Europe whose underlying system is registered in EUDAMED as a medical device.
The registration confirms that Gosta meets the EU MDR’s strict requirements for safety, performance, risk management, and quality systems. It also marks an important step forward for the responsible development and deployment of AI in European healthcare.
Unlike national registries maintained by individual Member State authorities, EUDAMED is the European Union's official and centralized database for medical devices and manufacturers, providing lifecycle monitoring and improving transparency, traceability and patient safety across Europe. It also serves as a key framework for the regulation of medical devices in the EU.
As the first AI Operating System registered as a medical device in EUDAMED, Gosta sets a new benchmark for regulatory transparency and establishes a robust, future-proof foundation for deployment across European healthcare systems.
The EU MDR is one of the world’s most demanding regulatory frameworks for medical devices. It applies to products intended for purposes such as the prevention, diagnosis, treatment, or prognosis of disease or injury.
Under the MDR, medical devices are classified into four categories: Class I, IIa, IIb, and III. The classification depends on the device’s intended purpose and the level of risk associated with its use. Gosta is registered as a Class I medical device. This means that it must comply with strict requirements related to safety, risk management, and product lifecycle governance.
In addition, the MDR requires a clinical evaluation to be conducted and maintained. The clinical evaluation assesses and documents the safety and clinical benefits of the device based on available clinical evidence and is updated as part of the ongoing surveillance and quality monitoring of the device.
As an EUDAMED-registered medical device, Gosta can support healthcare professionals with more robust clinical reasoning and advanced, context-aware classification of healthcare data in the automation of clinical documentation.
At the same time, it is important to emphasize that, in line with the definition of a Class I medical device, Gosta does not make diagnoses, provide treatment recommendations or replace the healthcare professional’s own clinical judgment. Responsibility for all clinical decisions always remains with the healthcare professional.
Registration in EUDAMED demonstrates that Gosta has been designed, tested and validated in compliance with EU MDR requirements throughout its entire product lifecycle. Patient safety and risk management are central to the system’s design, supported by documented development processes, continuous monitoring, and post-market surveillance.
Together, these elements create a strong and sustainable foundation for the responsible use of artificial intelligence in European healthcare.
