Ikerian Receives EU-MDR Certificate for Four Devices, its Ophthalmology Data Platform and AI Models

Ikerian announced it has received a European Union Medical Device Regulation (EU-MDR) certificate as Class IIa medical devices for its RetinAI Discovery digital data platform, as well as AI-based models to identify and quantify retinal layers, retinal fluids and retinal biomarkers to aid in the diagnosis and monitoring of diseases in ophthalmology.

“The EU-MDR is among the world’s most robust regulatory frameworks for healthcare technology, with the highest standards on the clinical investigation and sale of medical devices for patients,” Dr. Carlos Ciller, CEO and co-founder of Ikerian and RetinAI, said in a company news release. “The significant number of AI-based certified products we have obtained in ophthalmology highlights our dedication to innovation in the space to maintain high-quality standards in the development of our products, together with our compliance of GDPR data privacy and security laws in the EU. We are committed to providing top-notch healthcare data and AI solutions to patients and healthcare providers.”

The MDR replaces the former European Medical Device Directive (93/42/EEC), including more rigorous requirements for clinical evaluation and post-marketing surveillance. It is an internationally recognized regulatory framework to ensure improved device safety and requires device companies to provide clinical data supported by clinical evaluation, risk management and quality management systems. The long-standing MDD certificates the company obtained for its data platform and AI models—since 2021—have now been transitioned to MDR.  

To learn more, visit retinai.com/products/discovery.