Eudamed nomenclature requirements have been published

The European Medical Devices Coordination Group (MDCG) have endorsed a document regarding the requirements for a future European Union (EU) medical device nomenclature. This nomenclature, which will be used in Eudamed, will be made available for free to stakeholders and others. It is expected that the nomenclature system will be selected in 2018, although there is no confirmation by the authorities on the timeline.

The nomenclature is important for the development of Eudamed as a device must be linked to one of the nomenclature terms as part of its Unique Device Identification (UDI) data. This will allow comparison of data from different devices within one nomenclature group. In Annex VI, Part B, section 8 of the Medical Devices Regulation (MDR), the medical device code is required to be provided by the manufacturer when entering data for the UDI Device Identifier. The availability of the nomenclature in all EU languages is considered highly important, but it is not listed as a hard requirement.

The MDR states that the direct users of this nomenclature will be the manufacturers, as they have to link their devices with a specific term and add this term to the UDI database in Eudamed. The guidance document from the MDCG does not specify additional user groups, however it is likely that Notified Bodies, Competent Authorities and the European Commission will have access in order to carry out their supervising activities. The guidance states that free access can be linked to the nomenclature codes with a Single Registration Number (SRN), because the SRN is required for an economic operator to get access to Eudamed and is related to a specific role.

It is likely that the European Commission will soon propose a nomenclature system to the MDCG, and this may also set out specific characteristics of the system, for example the hierarchy in terms and the language(s) in which it will be made available. Considering other timelines of the transition to the MDR, it is expected that this decision may be made in 2018, however there is no official confirmation.

To view the ‘MDCG 2018-2 Future EU medical device nomenclature – description of requirements’, please click here.