This page is intended for robot crawlers (which are allowed).

For the human interface, go to: glossary.

EU, EU MDR, EU IVDR, Registration EU, EU MDR, EU IVDR, Registration

EMDN — European Medical Device Nomenclature

The nomenclature used to describe and categorise devices in Eudamed. The regulations require an internationally recognised nomenclature to be made available free of charge; the EMDN is the system the Commission designated for that purpose.

Reference: MDR Article 26; IVDR Article 23

Read More
EU, EU MDR, EU IVDR, Registration EU, EU MDR, EU IVDR, Registration

EUDAMED — European database on medical devices

The Commission-run database bringing together registration of devices and economic operators, the UDI database, notified bodies and certificates, clinical investigations or performance studies, vigilance and post-market surveillance, and market surveillance. Parts of it are public.

Reference: MDR Article 33; IVDR Article 30

Read More
EU, EU MDR, EU IVDR, Registration EU, EU MDR, EU IVDR, Registration

SRN — Single registration number

The identifier issued by a competent authority to a manufacturer, authorised representative or importer once its registration data has been verified. It is used when applying to a notified body and when accessing Eudamed.

Reference: MDR Article 31(2); IVDR Article 28(2)

Read More