The three guidelines issued by the Medical Device Coordination Group (MDCG) and published on April 9, 2018 provide the requirements for Medical Devices nomenclature as well as the list of data related to manufacturer and the device to be provided to the EUDAMED database:

“Future EU medical device nomenclature Description of requirements” describes in full detail the requirements and the criteria that the future nomenclature of Medical Devices is supposed to meet.

The future nomenclature was designed to facilitate connections with the codes that define the competence of Notified Bodies (designation scope), the scope of QMS/QA certificates for Medical Devices and the product portfolio under the legal responsibility of Authorized Representatives.

“The architecture of the UDI database – Basic UDI-DI and UDI-DI attributes for Medical Devices and in-vitro diagnostic Medical Devices” defines the basic UDI-DI as being “the primary identifier of the device model that must be entered into the UDI database and its corresponding documentation (such as certificates, declaration of conformity, technical documentation and summary of safety and clinical performance) whose purpose is to link Medical Devices with the same use, risk class and main design and production characteristics”.

The list of data to be included in the UDI database during the registration of any MD or IVR is published within “UDI database. Definitions, descriptions and formats of the UDI core elements ”.