Ikerian Receives EU-MDR Certificate for Four Devices

RetinAI U.S. parent company, Ikerian AG (“Ikerian”) has received registration as Class IIa medical devices under the European Union Medical Device Regulation (Regulation (EU) 2017/745) (EU-MDR) for four devices. 
 
The Certificate applies to RetinAI Discovery, a transformative healthcare platform of digital data in Ophthalmology, and the AI-based models that 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,” said Dr. Carlos Ciller, CEO and co-founder of Ikerian and RetinAI. “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.”
 
“This significant milestone is a reflection of our team’s hard work and commitment to deliver safe and reliable medical devices for healthcare,” says Dr. Sandro De Zanet, CSO and co-founder of Ikerian and RetinAI. “The EU-MDR Certificate of RetinAI Discovery and its AI models will firmly place confidence in healthcare providers across the European Union that we are delivering the highest standard of care to support the management of their patients in Ophthalmology.”
 
The EU-MDR Certification replaces the company’s former European Medical Device Directive (93/42/EEC) and includes more rigorous requirements for clinical evaluation and post-marketing surveillance. Ikerian’s prior MDD Certificates have transitioned to MDR.