Apr 17, 2018

EMERGO SUMMARY OF KEY POINTS:

  • The MDCG endorsed the requirements for nomenclature to be used in Eudamed.
  • This nomenclature will be made available for free to stakeholders and others.
  • Availability of the nomenclature in all EU languages is considered highly important, but it is not worded as a hard requirement.
  • It can be expected that the nomenclature system will be selected in 2018, although there is no confirmation by the authorities on that timeline.

Eudamed nomenclature for medical device UDI endorsed 2018At the March 2018 meeting of the European Medical Devices Coordination Group (MDCG), a document has been endorsed regarding the requirements for a future EU medical device nomenclature.

This nomenclature is important for the development of Eudamed; a device must be linked to one of the nomenclature terms as part of its Unique Device Identification (UDI) data. This will allow comparing data from different devices within one nomenclature group. In Annex VI, Part B, section 8 of the Medical Devices Regulation, the medical device code is required to be provided by the manufacturer when entering data for the UDI Device Identifier (UDI-DI).

Nomenclature requirements in the MDR

Article 26 of the MDR (article 23 of the IVDR) requires the European Commission to ensure the availability of an internationally recognized nomenclature:

Article 26 MDR

Medical devices nomenclature

To facilitate the functioning of the European database on medical devices (‘Eudamed’) as referred to in Article 33, the Commission shall ensure that an internationally recognised medical devices nomenclature is available free of charge to manufacturers and other natural or legal persons required by this Regulation to use that nomenclature. The Commission shall also endeavor to ensure that that nomenclature is available to other stakeholders free of charge, where reasonably practicable.

This article requires the nomenclature to be available for free to all who are required by the MDR to use this nomenclature. According to the MDR the direct users of this nomenclature are 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 does not specify additional user groups. However, it is obvious that Notified Bodies, Competent Authorities and the European Commission will have to have access in order to perform their supervising activities. It will be relatively straightforward to link free access 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. The guidance document fully confirms this scenario.

Global Eudamed access?

But article 26 does not stop at direct users. It also puts the onus on the Commission to strive for Eudamed availability for other stakeholders. These other stakeholders may not have SRNs and will only search Eudamed, without entering data. These users could be anybody, for example healthcare providers. They need to be able to understand what a nomenclature code stands for; therefore they obviously need access to the nomenclature database. Their ability to search for and compare specific device types will help them during their purchasing processes, and easier access to vigilance data may help in promoting safety. As this is not a group with strictly regulated access to Eudamed, access can only be arranged by giving access to the nomenclature terms without any limitations. This would imply that any nomenclature system would be available to the whole world.

The guidance document expresses the wish that this nomenclature system should be available in all languages of the European Union. This has been tried before with the GMDN codes, but there were too many changes in the descriptions and too many conflicts in the translations. Therefore this experiment only lasted for three years. It is highly likely the terms will only be available in English despite the desire to have a multi-language system.

Which device nomenclature system for Eudamed?

Right now it is not yet decided which system of nomenclature will be used. There are several systems available, and the system used for Eudamed will get a very strong boost in becoming a world standard. This may provide the European Commission with a strong negotiating position when it comes to the terms and costs of this system.

The European Commission will likely soon propose a nomenclature system to the MDCG. This decision will most likely also set out specific characteristics of the system, like 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 can be expected that this decision will be made sometime in 2018, but no official confirmation has been given regarding this specific timeline.

Additional European medical device regulatory resources

  • European CE Marking strategy and consulting for medical devices
  • European MDR 2017/745 gap assessment and CE Mark transition consulting
  • On-site European MDR training for medical device manufacturers
  • Whitepaper: European MDR transition timelines and strategies