The European Commission announced the selected medical device nomenclature to support the IVDR and MDR implementation will be the Italian CND nomenclature, to be mapped to the GMDN nomenclature. The CND nomenclature will be made available in the future EUDAMED.
In accordance with Article 23 of the IVDR 2017/746 (and Article 26 of the MDR 2017/745) the Commission is required to make available a medical device nomenclature to support the functioning of the European Database on medical devices (EUDAMED).
This decision was taken following a long process of information gathering and evaluating of options. This process came to completion and at the Medical Device Coordination Group (MDCG) meetings of 30 November 2018 and 14-15 February 2019 relevant discussions took place.
The MDCG endorsed document “MDCG 2018-2 Future EU medical device nomenclature Description of requirements” , published 9th April 2018, provides a detailed description of requirements and criteria that the future nomenclature is expected to fulfill. The nomenclature will play an essential role to:
- guarantee the good functioning of the future EUDAMED – the nomenclature is one of the core data elements to be provided in accordance with Annex VI Part B point 8.
- fulfill of some of the regulatory objectives, such as:
- facilitating effective market surveillance operations;
- facilitating device traceability throughout the supply chain.
In accordance with the requirements laid down in the aforementioned document (MDCG 2018-2), the Commission also announced that it will set up a sub-group of the MDCG in order to provide better regulatory oversight over the EU nomenclature system. This oversight shall be aimed to:
- ensure that the terminology structure used is not unnecessarily granular and should not contain names that are only used by only a few economic operators or stakeholders;
- ensure that the structure and design of the future nomenclature facilitates 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 (one generic device group should belong only to one AR).
The nomenclature should have hierarchies by which terms and codes could be meaningfully grouped into categories and subcategories.
What does this mean to you?
This announcement is only the beginning, but it will eventually require you to transition to a new device nomenclature. You can start familiarising yourselves with the new nomenclature and investigate how you will tackle this in your ERP systems (replace GMDN by CND or have both codes) to ensure device master data can be updated easily. Once the mapping of the CND nomenclature to the GMDN nomenclature has been done you can update your device master data to reflect the new codes.