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In brief

On 4 May 2021, the official Italian version of the European Medical Device Nomenclature (EMDN), to be used for the registration of medical devices in the Eudamed database, was published. The EMDN has been developed on the basis of the Italian National Classification of Medical Devices due to its characteristics in terms of structure, purpose, usability and updating methodology.


What’s new

As the EMDN primarily serves regulatory purposes to meet the requirements of the EU Regulations on medical devices and in vitro diagnostics, it also plays a key role, for example, in the preparation of the technical documentation for devices, in the sampling of the same documentation by notified bodies as well as in the post-market review and analysis of data. In addition, it provides the description of devices used and of those available on the market and registered in Eudamed.

In this regard, it should be noted that the English version of the EMDN is still in the process of being finalized and that a consultation on the relevant draft, ended on 4 June, has been carried out to collect suggestions on the syntax or reports of possible translation errors from the healthcare community. The final English version is expected to be published in the third quarter of 2021.

Author

Roberto Cursano is a counsel in Baker Mckenzie since 2007 in Rome, Italy office. His practice focus more in pharmaceutical and healthcare law matters and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts.

Author

Riccardo Ovidi is an associate in Baker McKenzie's Rome office.

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