May 4th, 2021, the first version of the European Medical Device Nomenclature (EMDN) was released by the European Commission.
Per Article 26 of Regulation (EU) 2017/745 on medical devices (MDR) and Article 23 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), the EMDN aims at supporting the functioning of EUDAMED. Among its various uses, it will be utilised by manufacturers for the registration of medical devices in EUDAMED, where it will be associated to each UDI-DI.
The EMDN was founded following a European Commission notice indicating the utilisation of the Italian Ministry’s “Classificazione Nazionale Dispositivi medici (CND)” as the basis for the future EMDN.
The entirety of the EMDN is accessible to all stakeholders, free of charge.
The EMDN has an alphanumeric structure that is established in a seven-level hierarchical tree. It clusters devices into three main levels:
- Categories: the first hierarchical level
- Groups: the second hierarchical level
- Types: the third hierarchical level (which expands into several levels of detail (1°, 2°, 3°, 4° and 5°), where necessary.
You must always assign the most granular and terminal term available (lowest level in the tree) to your device.
May 18th, 2021 the UDI Helpdesk was launched. The helpdesk aims to provide support to economic operators in the implementation of the obligations and requirements introduced by the new UDI system, which include UDI assignment, labelling and registration of devices. The helpdesk will also provide support as regards the use of the European Medical Devices Nomenclature (EMDN).
What does this mean to you?
Start using this version of the EMDN when establishing the generic device groups applicable to your devices and when identifying the exact nomenclature that applies to your devices. The EMDN plays a key role in MDR/IVDR device documentation and technical documentation, sampling of technical documentation conducted by notified bodies, post-market surveillance, vigilance and post-market data analysis, etc.
The UDI helpdesk maybe a valuable supporting tool in case of questions that arise from the UDI requirements laid down in the MDR and IVDR.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.
