OphtAI, medical AI in ophthalmology that meets European regulatory requirements
The safety and reliability of medical devices are major challenges in the digital transformation of the healthcare sector. Since May 2021, the European Medical Devices Regulation 2017/745 has imposed stricter requirements on manufacturers in terms of quality, performance and traceability.
In this context, OphtAI, a Class IIa medical device based on artificial intelligence (AI) for the automated analysis of retinal images, has obtained MDR certification. This recognition is a key milestone for the company and, more broadly, for the ophthalmic e-health ecosystem.
OphtAI CE certified according to the MDR, a guarantee of safety and performancesécurité et de performance
Developed by Evolucare and ADCIS, OphtAI is software that integrates AI capable of detecting major retinal diseases (diabetic retinopathy, glaucoma, AMD, etc.) in diabetic patients from photographs of the fundus.
Thanks to training on more than 800,000 images annotated by experts from the AP-HP’s OphDiaT network, the solution offers performance comparable to that of an experienced retinologist, while enabling rapid, standardised and cost-effective screening.
MDR certification confirms the clinical reliability, technical robustness and regulatory compliance of the technology. Issued by GMED (0459), it certifies that the device meets European standards for performance and patient safety.
Following a rigorous assessment conducted by the GMED, MDR certification was officially validated thanks to the excellent work of our teams.
A demanding process, conducted with rigour and collaboration
Obtaining MDR certification is not a simple administrative formality: it is the result of several years of hard work.
OphtAI, a subsidiary of Evolucare Technologies, has been working to adapt its quality system and all technical documentation for its medical devices to comply with the requirements of the new European regulation since its publication in 2017.
The GMED assessment covered the entire life cycle of the Evolucare OphtAI product: design, risk management, clinical evaluation and post-market surveillance.
This approach involved cross-functional collaboration between the research, regulatory and development teams and clinical partners, with the aim of meeting regulatory requirements while responding to the expectations of healthcare professionals and patients.
A certification that boosts the confidence of healthcare professionals
In the field of visual health, trust in diagnostic aids is essential.
MDR certification provides objective proof of reliability, reinforcing the legitimacy of Evolucare OphtAI among ophthalmologists, orthoptists, optometrists and industrial integrators.
In practical terms, this certification:
- guarantees the security and traceability of analysed data;
- confirms the clinical value of artificial intelligence algorithms;
- facilitates integration into hospital and connected environments (interoperability, GDPR compliance, HDS hosting);
- supports the international deployment of OphtAI in regulated European markets.
Obtaining MDR certification is much more than a regulatory achievement. It is recognition of a scientific requirement and a shared responsibility: that of ensuring patient safety while accelerating access to innovation.
MDR: a demanding framework for a more secure future
Regulation (EU) 2017/745, which came into force in 2021, has profoundly transformed the landscape of medical devices in Europe. It replaces Directive 93/42/EEC and introduces new obligations for manufacturers:
- in-depth and continuous clinical evaluation;
- enhanced transparency via the European EUDAMED database;
- structured post-market surveillance;
- full traceability of devices thanks to UDI (Unique Device Identification) identifiers.
For companies in the sector, this regulatory change is demanding, but it establishes a higher level of trust between manufacturers, healthcare professionals and patients.
For OphtAI, it is part of a commitment to quality, ethics and transparency that has guided its actions since its creation.
Recognition that opens up new prospects
Thanks to this certification, Evolucare OphtAI has consolidated its position as the European leader in the field of ophthalmic AI.
The company can now accelerate the roll-out of its solutions in new European markets, while continuing to develop solutions for other retinal diseases (venous occlusions, high myopia, retinitis pigmentosa, etc.).
This recognition also strengthens partnerships with retinograph manufacturers, tele-ophthalmology centres and healthcare institutions, with a view to large-scale preventive screening.
A key step towards safer ophthalmic e-health
OphtAI’s achievement of MDR certification symbolises a double success: exemplary compliance and an ethical commitment to patient safety and quality of care. In a rapidly expanding sector, where technology and medicine converge to improve the vision of millions of people, this certification provides an essential guarantee: that of trust.
💬 Alexandre Le Guilcher:
« Our ambition remains unchanged: to make artificial intelligence a reliable, accessible and responsible tool for professionals and their patients. »