Topcon Healthcare’s Harmony Referral System Achieves MDR Class IIa Certification
Topcon Healthcare is pleased to announce that the Harmony Referral System (version 3) has been certified as a Class IIa medical device under the European Union Medical Device Regulation (EU MDR) 2017/745.
This certification affirms that Harmony meets the stringent EU regulatory framework for medical-grade software, including safety, performance, clinical evaluation, and quality management. The MDR Class IIa designation confirms Harmony’s role as a clinical data management platform designed to aid in diagnostic processes and clinical decision-making.
Harmony is a cloud-based system that enables eye care providers to connect and manage data from all diagnostic instruments—regardless of manufacturer—within a single platform. Its seamless integration capabilities enhance clinical workflows, facilitate collaboration, and help deliver better patient outcomes.
The MDR certification follows a comprehensive conformity assessment by a notified body and underscores Topcon Healthcare’s commitment to innovation excellence and regulatory compliance.