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.
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.