Glossary term
Notified Body
Reference only — not medical advice. See disclaimer.
An organisation designated by an EU member state to assess the conformity of certain products, including medical devices, with EU regulations before they can carry the CE mark. For implantable devices such as breast implants, dental implants, and orthopaedic prostheses used in EU countries, the Notified Body number on the device passport identifies which conformity assessor approved that specific product line.