Alaya, Cyber Surgery’s spinal robotic assistant, is CE-certified under the Medical Device Regulation (MDR), ensuring safety, quality, and traceability for clinical use across Europe.
A milestone in clinical safety and innovation.
ALAYA, Cyber Surgery’s spine robotic assistant, has been CE marked under the new EU Medical Device Regulation (MDR), confirming its readiness for clinical use across Europe. This certification sets a new standard of quality and trust, achieved through rigorous evaluation of clinical evidence, quality management, and full traceability.
From compliance to clinical confidence.
Under the MDR (Regulation EU 2017/745), CE marking confirms that ALAYA meets the most stringent European standards for safety, performance, and reliability. For hospitals and surgical teams, this means having confidence in a robotic system that has been validated for real-world use and patient safety.
Traceability and Continuous Improvement.
ALAYA integrates UDI (Unique Device Identifier) and EUDAMED data to provide complete traceability from design to the operating room. Additionally, Cyber Surgery implements an active postmarket surveillance (PMS) and clinical follow-up (PMCF) program that uses real-world data to enhance safety and performance continuously.
Cybersecurity by Design.
ALAYA’s layered cybersecurity architecture is fully compliant with IEC 62304 and GDPR. It ensures controlled updates, data integrity, and protection within hospital networks, meeting the MDR’s highest standards for connected medical devices.
Ready Today, Built for the Future.
MDR certification establishes ALAYA as a reliable, compliant solution for European hospitals. This certification reinforces Cyber Surgery’s mission to combine technological precision with patient safety, setting a new standard for robotic systems in spine surgery.
ALAYA is CE marked under MDR — ready for clinical use across Europe.
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