The CE mark means "Conformité Européenne", which means "European Conformity". The CE marking is used not only for medical devices, but also for products such as wine or beer, consumer electronics, toys, and many other items. The CE mark is a quality certificate indicating that a product complies with European Union health, safety, and environmental regulations.
Since the image processing system is clearly a class 1 medical device, the CE mark is required for sales of the system in Europe. Such certification is required in other countries, such as FDA registration in the United States. You can consider the ce sign in UK to pass the product has been assessed by the manufacturer and deemed to meet EU safety, health, and environmental protection requirements
Vision apparently received the CE mark in 2017 with the help of vision GMBH (our European distributor in Germany). “We believe it is very important (and useful) to make the necessary efforts to meet all EU standards.
In order to receive the CE mark, the company must prepare a complete technical document that proves the conformity of the product with all applicable regulations. The Clear Vision System has also been independently assessed by the European Notification of Conformity. All documents are kept on file and must be sent to regulatory authorities upon request.
A quality system development process that includes rigorous documentation of all processes is essential when conducting clinical trials and submitting approval to institutional review boards in hospitals and universities. In many cases, this goes beyond pure technical documentation and includes performance data and historical data from such studies.