Easee, a digital healthcare speicalist, has achieved the CE mark Class II under the new European Union Medical Device Regulation (Regulation (EU) 2017/745) (EU-MDR) which the company says is the world's first and only CE certified online eye exam with refraction capabilities.
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Easee
In addition to this certification, Easee also holds the ISO 13485 certification, further establishing its dedication to international quality management and safety standards in the medical device industry.
Dr. Robert Wisse, chief medical advisor at Easee, said: “With our team we celebrated this new certification under EU-MDR as it is the ultimate recognition for everything we believe in at Easee. This recognition is also a significant moment for digital health innovation globally. Maintaining our position as the first and only CE certified online eye exam while meeting the new, stringent MDR requirements showcases our leadership in the field. We continue to lead the way in providing safe, effective, and accessible digital eye care solutions worldwide.”
With its solutions, Easee augments traditional eye care with hybrid at-home solutions, integrating with various digital channels.
