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.
You can Because the vision system is clearly a class 1 medical device, the CE sign is needed to sell systems in Europe. In other countries, similar certification is needed, such as FDA registration in the US. You can consider the CE certification cost for demonstrates compliance with the appropriate manufacturing standard for a product.
The CE sign is a sign of quality certification that shows products that are in accordance with the health, applicable safety, and environmental regulations in the European Union.
To get CE marking, the company must compile extensive technical documentation that demonstrates product suitability with all applicable regulations. A clear vision system has also been assessed independently by the European notification body for conformity. All documentation is stored on 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 submitting approval from the institutional review board in hospitals and universities. This surpasses only technical documentation in many cases and includes data on the effectiveness and historical data from similar scientific studies.