The Medical Device Coordination Group (MDCG) recently published MDCG 2024-2, Procedures for the updates of the European Medical Device Nomenclature. The document lays out details regarding stakeholders and timelines for regular updates of EMDN codes. As a reminder, EMDN codes represent the nomenclature of medical devices under the medical devices and in vitro diagnostic medical devices regulations (MDR and IVDR).
The procedure enables users of the nomenclature system to request, for example, the assignment of new codes. These will then be evaluated and potentially published at the end of a calendar year if the request was submitted by January 31 of the same calendar year the latest. MDCG 2024-2 also provides for an expedited ad hoc review for new codes. Additional details, e.g. a link to the platform for EMDN requests are contained in the guidance document.
Furthermore, MDCG 2024-3 was published, Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices. The guidance generally references annex XV of the MDR and standard ISO 14155:2020. It provides advice on specific aspects that are required in clinical investigation plans, such as benefits and risks of the investigational device and the clinical investigation, objectives and hypotheses, the investigation design, statistical design and analysis and adverse event handling.
Manufacturers and economic operators are highly recommended to consider the documents if applicable.
Source: MDCG
