CE marking stands for "Conformité Européenne," which means "European suitability." CE tagging is not only used for medical products, but also for products such as wine or beer, consumer electronics, toys, and many other items.
The CE sign is a sign of quality certification that shows products that are in accordance with health, applicable safety, and environmental regulations in the European Union. You can consider the ce marking after brexit to ensure your product has been assessed by the manufacturer and deemed to meet EU safety, health, and environmental protection requirements.
This vision clearly received a CE sign in 2017, with the help of GMBH Vision (our European distributor in Germany). "We feel critical (and useful) to spend efforts needed to meet all standards in the EU." Brian Dornbos's comments, eyewear experts, and head compliance at a clear vision. "The quality management system must be made and internalized for the entire company. This leads to better products for our end users in the long run."
To get a CE sign, the company must compile extensive technical documentation that demonstrates product suitability with all applicable regulations. A clear vision system has also been independently assessed by the European notification body for suitability. All documentation is stored in the file and must be sent to the regulatory entity on request.
The process of developing a quality system that includes strict documentation of all processes is very important when conducting clinical studies and sending approval from the institutional review Board in hospitals and universities. This only exceeds technical documentation in many cases and includes data on historical effectiveness and data from similar scientific studies.