Edit: I stand corrected, there is a specialized CE certification that reviews limited fitness for purpose, although it does not seem very comparable to something like FDA requirements for double blind testing etc., so I'm still highly skeptical. Original comment: There may be something here, but their presentation leaves a "snake oil" impression. Mostly because of their repeated emphasis on "CE" certification, as tho…
No, there is CE marking for medical devices in the EU which means it has achieved conformity for the Medical Devices directive. Generally equivalent to FDA regulation.
However it does not seem comparable to a fairly rigorous FDA double-blind experimental process requirements, it only requires the manufacturer to provide a clinical evaluation that appears to be just a little more than a literature review [0][1]
[0]https://www.emergobyul.com/services/europe/ce-certification
[1]https://www.emergobyul.com/sites/default/files/eu-meddev-2_7...