Why is the CE Mark important?

Because the Vivid Vision system is a Class 1 Medical Device, the CE Mark is required in order to sell the system in Europe.

What does it mean when a CE marking is associated with a product? 

The CE marking stands for "Conformité Européenne," which means "European Conformity.” The CE marking is not only used for medical products, but also for products like wine or beer glasses, consumer electronics, toys, and many other items. The CE Mark is a quality certification mark that indicates a product complies with any applicable health, safety, and environmental regulations within the European Union. Because the Vivid Vision system is a Class 1 Medical Device, the CE Mark is required in order to sell the system in Europe. In other countries similar certifications are needed, like FDA registration in the USA. 

Vivid Vision received the CE mark in 2017, with the help of VISUS GmbH (our European distributor in Germany). “We find it critical (and rewarding) to spend the required effort needed to fulfill all standards in the EU.” remarked Brian Dornbos, optometrist and Chief Compliance Officer at Vivid Vision. “A quality management system had to be created and internalized for the entire company. This leads to better products for our end-users in the long-run.” 

In order to obtain the CE Marking, companies must compile extensive technical documentation that shows product conformity to all applicable regulations. The Vivid Vision system has also been independently assessed by a European notified body for conformity. All documentation is kept on file and must be delivered to regulatory entities upon request.  

This process of developing a quality system that includes rigorous documentation of all processes is critical when conducting clinical studies and applying for approval from institutional review boards at hospitals and universities. This goes beyond just technical documentation in many cases, and includes data on effectiveness as well as historical data from similar scientific studies. Essentially, CE is just the tip of the proverbial iceberg—everything below the surface of the water is critical documentation that supports the validity of the CE mark for the product. To a consumer, most of the work Vivid Vision has done to get and keep CE is invisible but nonetheless important! 

In order to maintain the high quality of Vivid Vision as a medical product with CE marking, we collect customer (provider) and patient feedback. Feel free to send us your feedback at: contact@seevividly.com

Find a Provider ce mark europe vivid vision europe visus gmbh amblyopia lazy eye regulatory compliance

Find a Vivid Vision Provider

Over 380 Vivid Vision Providers prescribe virtual reality alongside patching and vision therapy to treat your lazy eye. Sign up through our doctor locator to see if Vivid Vision is right for you.

  • Eye Problems
  • Ptosis
  • Binocular Vision
  • Vision Tests
  • Suppression Tests
  • Worth 4 Dot
  • Tests of Stereopsis
  • Cover Test
  • Definitions
  • Signs and Symptoms
  • Blurry Vision
  • Reading Problems
  • Eye Strain
  • Driving Problems
  • Headaches
  • Suppression
  • Double Vision
  • Motion Sickness and Car Sickness
  • Visual Skills
  • Visual Tracking
  • Visual Fixation
  • Stereopsis
  • Depth Perception
  • Visual Accommodation
  • Visual Requirements for Baseball
  • Visual Requirements for Pilots
  • Reading
  • Foundational Reading Skills
  • Vision and Learning
  • Fusion
  • Convergence and Divergence
  • Reading Skills
  • Visual Processing
  • Lazy Eye
  • History of Lazy Eye
  • Convergence Disorders
  • Convergence Insufficiency
  • Exophoria
  • Esophoria
  • Medical Terms
  • Accommodation Disorders
  • Accommodative Esotropia
  • Accommodative Insufficiency
  • Amblyopia
  • Lazy Eye in Adults
  • Strabismic Amblyopia
  • Refractive Amblyopia
  • Anisometropia
  • Critical Period
  • Strabismus
  • Anomalous Retinal Correspondence
  • Transient Strabismus
  • Exotropia
  • Esotropia
  • Hypotropia
  • Hypertropia
  • Lazy Eye Treatments
  • Optometric Vision Therapy
  • Eye Exercises
  • Pencil Pushups
  • Brock String
  • Vision Therapy
  • Sports Vision
  • Virtual Reality
  • Red Green Glasses
  • Vision Therapy for Adults
  • Vision Therapy Apps
  • Vectograms
  • Eye Drops for Amblyopia
  • Strabismus Surgery
  • Eye Patching
  • Prism Glasses
  • Dichoptic Training
  • Binasal Occlusion
  • Reading
  • Are you a patient interested in using Vivid Vision?

    Find a Vivid Vision Provider near you!