In 3-4 years ago, there was no difficulty in CE certification, so certification was issued in 3 months after audit as soon as possible, and it was about 6 months at the latest.

In the European Union, due to the flood of products whose safety is not guaranteed by easy certification, and the urgency that the safety of patients cannot be guaranteed, the certification conditions have been strengthened, and the system has been converted to a higher level through strict screening. (From MDD : Medical Device Directive to MDR : Medical Device Regulation)

As all companies around the world are focused on two NB(Notified Bodies), the certification work has been delayed considerably, and our Anyfusion’s European certification took more than three years, making it difficult to get certification on May 13th.

Now with CE certification, Anyfusion can be sold not only in Europe, but also in the Middle East and Asia.

Thank you.