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, describes the company.

This makes it the first AI assistant in Europe whose underlying operating system has been registered in EUDAMED as a medical device.

EUDAMED

EUDAMED is the EU’s centralized database for medical devices, designed to enhance transparency, traceability, and patient safety across Europe. Registration means the system complies with the MDR’s strict requirements regarding safety, performance, and risk management. 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, it states.