Notified body
Short definition
A notified body is an independent organisation, designated by a Member State, that assesses the conformity of medical devices with Regulation (EU) 2017/745 before they are placed on the market.
In plain language
It is involved mainly with Class IIa, IIb and III devices, auditing the quality management system and technical documentation and issuing certificates. For ordinary Class I devices, the manufacturer self-declares conformity without a notified body. The list of designated bodies is public, in the European Commission's NANDO database.
In practice, in an RVer session
RVer, as a Class I device, has no notified body: its CE marking is self-declared.