Comment by brandonb
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.