CHICAGO—Visibly, developer of the world's first FDA-cleared online visual acuity test, has received CE Mark Approval in the European Union (EU) for their Visibly Digital Acuity Product (VDAP), demonstrating compliance with the EU Medical Device Regulation (MDR), according to an announcement from the company. The company said in a statement that it has also received the EN ISO 13485 certification, adding this further demonstrates Visibly's commitment to innovation and quality products designed for effective vision care. This international standard ensures consistency and efficacy of medical devices' design, development, production and delivery processes, signifying they are safe for their intended purpose.

"These significant milestones are a testament to the dedication the Visibly team has shown in expanding safe and effective vision care services to consumers,"  said Michael Vader, vice president of regulatory affairs and quality assurance at Visibly, Inc. "The CE Mark Approval of VDAP in the EU marks the first significant step in expanding Visibly's platform into the global marketplace, helping us achieve our goal of expanding affordable access."

The company added that Visibly's online vision platform continues to expand affordable access to vision care for millions of consumers. With CE Mark Approval of VDAP and EN ISO 13485 certification of the quality management system, the company said that, consumers in the EU will soon have access to Visibly's on-demand, self-administered visual acuity test from their home using a combination of a touchscreen mobile device and computer connected to the internet. 

"These certifications are proof of the consistency and efficacy of Visibly's online visual acuity test design and delivery processes. We are excited about the opportunities ahead and remain committed to increasing access to vision care solutions," said Brent Rasmussen, CEO of Visibly. He added that the company is looking forward to partnering with leading EU optical organizations to equip eyecare professionals with digital solutions to expand their patient reach.