In brief
On medical devices, the CE marking indicates that the manufacturer declares conformity with the requirements of Regulation (EU) 2017/745. For risk classes above Class I (except in specific cases), it is accompanied by the number of the notified body involved.
Who affixes the marking
The manufacturer, after completing the conformity assessment procedure required for the device's class.
The notified body
For Class I devices that are non-sterile, have no measuring function and are not reusable surgical instruments, the assessment is generally carried out by the manufacturer. For other classes, a notified body steps in, and its number appears alongside the CE mark.
CE marking doesn't mean "all the same"
The same CE marking is used across many different directives and regulations: to tell whether a product is a medical device, you need the declaration of conformity.
