Ikerian Receives EU-MDR Certificate for Four AI-Based Medical Devices

Ikerian has received European Union Medical Device Regulation (EU-MDR) certificate for its RetinAI Discovery digital data platform and AI-based models. These products have been classified as Class IIa medical devices, affirming their adherence to stringent regulatory standards for healthcare technology.

Emphasis on Regulatory Standards and Innovation

Dr. Carlos Ciller, CEO and co-founder of Ikerian and RetinAI, emphasized the EU-MDR's role in ensuring high standards for the clinical investigation and commercialization of medical devices. "The significant number of AI-based certified products we have obtained in ophthalmology highlights our dedication to innovation," stated Dr. Ciller in a company news release. He underscored Ikerian's commitment to upholding GDPR data privacy and security laws, reinforcing their pledge to deliver advanced healthcare data and AI solutions for patients and healthcare providers.

Transition from MDD to EU-MDR

The EU-MDR replaces the former European Medical Device Directive (93/42/EEC) with more rigorous requirements for clinical evaluation and post-marketing surveillance. It serves as an internationally recognized regulatory framework aimed at enhancing device safety, necessitating companies like Ikerian to provide robust clinical data supported by thorough evaluation, risk management, and quality management systems.

Ikerian had previously obtained Medical Device Directive (MDD) certificates for its data platform and AI models starting from 2021. These certificates have now successfully transitioned to EU-MDR compliance, marking a continued commitment to maintaining high-quality standards in healthcare technology innovation.

This achievement positions Ikerian at the forefront of ophthalmic AI innovation, empowering healthcare providers with advanced tools for the diagnosis and monitoring of diseases.