Glossary Term
Notified Body
Regulatory DefinitionsEN
Definition
An organisation designated by an EU member state to assess the conformity of products — including in vitro diagnostics — against applicable regulations before CE marking can be affixed.
Extended Notes
Under the IVDR, most IVDs require Notified Body involvement (a major change from the self-certification common under the IVDD). Notified Body designation scopes are device-specific, so a certificate’s validity depends on the body’s designation covering that device type.