Pepers01, I totally agreed with your analysis. There is no point...

Pepers01, I totally agreed with your analysis. There is no point to speculate what's they meant by "at this time insufficient clinical benefit has beendemonstrated to recommend approval."

A lot of people would understand CE Mark is very different to FDA, but they may not know that CE Mark it is NOT intended to be a quality mark. See BSI info here https://www.bsigroup.com/en-AU/Our-services/Product-Certification/CE-mark/

In summary then, the CE marking indicates that the manufacturer has met the minimum legal requirements for their products in regard to health and safety under European Directives. CE marking is not, therefore, intended to be a quality mark.