Easee Reinforces Leadership in Digital Eye Care with New MDR Class 2a Certification

Tags: #Human #Medical #Technology

Continues to be the World’s First and Only CE Certified Online Eye Exam, Now Meeting Rigorous MDR Standards

Amsterdam, 5 Dec 2023 – Easee, a leader in digital healthcare innovation, today announces a significant milestone in its journey: the company’s online eye exam platform has successfully achieved the CE Class 2a certification under the new European Union Medical Device Regulation (Regulation (EU) 2017/745) (EU-MDR), reaffirming its status as the world’s first and only CE certified online eye exam with refraction capabilities. The certificate was issued after a comprehensive audit by TUV Reinland, one of the leading MDR certified notified bodies. This landmark achievement not only consolidates Easee’s position at the forefront of digital eye care but also distinguishes it as one of the few companies to have successfully navigated the stringent requirements of the MDR for Software as a Medical Device (SaMD).

Previously recognized under the old Medical Devices Directive (MDD), Easee’s renewed certification under the MDR is a testament to its unwavering commitment to safety, efficacy, and quality in digital healthcare. The MDR represents a significant upgrade in regulatory standards and ensures public health and patient safety. Achieving this certification also underlines the quality of our team when it comes to Quality Assurance and Regulatory Affairs.

In addition to this notable certification, Easee proudly holds the ISO 13485 Certification issued by TUV Reinland, further establishing its dedication to international quality management and safety standards in the medical device industry.

Dr. Robert Wisse, Chief Medical Advisor at Easee, remarked, “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.”

Easee’s online eye exam platform enables the digital revolution in the eye care industry by offering a reliable, convenient, and accessible solution for eye examinations including full refraction. With its enterprise solutions, Easee augments traditional eye care with hybrid at-home solutions,integrating seamlessly with various digital channels.

About Easee

Easee is an international leader in digital eyecare, specialized in telemonitoring and hybrid care pathways. Founded by a team of visionaries, doctors, and technology experts, Easee is committed to transforming the delivery of eye care worldwide. Its online eye exam platform, now certified under the new MDR, exemplifies its innovative approach, combining medical expertise with cutting-edge technology to offer accessible and accurate eye measurements including full refraction. The company collaborates with healthcare providers and governments to advance digital healthcare solutions.

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