CE marking
Short definition
CE marking is the mark by which the manufacturer indicates that the device meets the applicable requirements of European legislation, a condition for marketing it in the European Union.
In plain language
For medical devices, it is laid down in Article 20 of Regulation (EU) 2017/745. Before affixing it, the manufacturer must complete the conformity assessment appropriate to the device's class and issue the EU declaration of conformity. On higher-class devices, the mark is accompanied by the number of the notified body involved.
In practice, in an RVer session
RVer's CE marking is self-declared, as the MDR provides for Class I devices, with no notified body.