Notified bodies are authorised to assess compliance of medical devices with applicable requirements.

Notified bodies are involved before placement of medical devices on the market, except for Class I medical devices, custom-made devices and in-vitro diagnostic medical devices, other than included in Annex II to Directive IVD.

The EU network of New Approach Notified and Designated Organisations (NANDO) is available at: http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notifiedbody.main