The CE Mark in the European Union and the FDA-approval process in the United States both perform the same functions, namely assessing the safety and efficacy of new products and devices.
FDA approval always requires a full clinical trial or trials, whereas the CE Mark can be obtained through a clinical evaluation—a review of published data for existing equivalent devices.
For a clinical evaluation, the only requirement is that the manufacturer conduct a post market clinical follow-up study once the CE Mark is obtained.
The CE Mark is recognized almost globally—in addition to being valid in all countries of the European Union. By comparison, FDA approval is valid only in the United States. For this reason, it is more attractive to companies to apply for the CE Mark first. Having said that, FDA clinical trials are high-quality studies, so they do represent important milestones in the progression of scientific research in refractive surgery.
For your safety, our products are certified across the globe and go through stringent quality control processes.
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