Device Nomenclature: European Commission Explains What’s Coming

Regulatory NewsRegulatory News | 03 May 2018 |  By 

The European Commission last month began explaining the details of how a future system for medical device nomenclature will help to support the EU’s new device and IVD regulations, as well as the Eudamed database, which allows for information to be exchanged between national competent authorities and the Commission.

The nomenclature, which will be freely available to all stakeholders, will further align the EU with the International Medical Device Regulators Forum (IMDRF) and the World Health Organization, in addition to aiding market surveillance and device traceability operations.

“The structure and design of the future nomenclature should facilitate the establishment of links with the codes defining Notified Bodies competence (designation scope), the scope of medical devices QMS (Quality Management System)/QA (Quality Assurance) certificates, and product portfolios in the mandate of Authorised Representatives,” the commission said in a document endorsed by the Medical Device Coordination Group (MDCG).

And a team of EU regulators will review, determine (“preferably within a global perspective”) and validate the rules for updating, removing and creating names and descriptions to be included in the nomenclature, the Commission noted.

Eudamed also “shall make available the most updated names/codes related information, to the benefit of operators and general public,” the Commission added. “Therefore, the nomenclature provider will need to have procedures and services in place that shall allow EUDAMED to be kept up-to-date at any time. When setting the procedure, in particular the frequency, related to the periodic review of nomenclature terms and descriptions, this shall be taken into account.”

MDCG 2018-2 Future EU medical device nomenclature – Description of requirements


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