CE marks aren't an equivalent to an FDA approval process, they're self-certified with no real oversight.
> By affixing the CE marking to a product, a manufacturer declares that the product meets all the legal requirements for CE marking and can be sold throughout the EEA.
> Please note that a CE marking does not indicate that a product have been approved as safe by the EU or by another authority. It does not indicate the origin of a product either.
I'm not an expert on European law, but the requirements listed here for a CE mark indicate that the EMA reviews the safety and performance of the device and audits the manufacturer's quality systems, similar to the FDA:
https://www.ema.europa.eu/en/human-regulatory-overview/medic...
CE marks for other categories may well be self-certified.
I suppose I could have been a bit more precise in my terminology, and said the EMA (who gives the CE mark) is the equivalent of the FDA in Europe.
