Ministero della Salute

On 20 March 2023 the project SMEMDN - Supporting the maintenance of the European Medical Device Nomenclature, within the framework of the European Union (EU) EU4Health 2022 Work Program, officially started.

The project defines the activities necessary for the support and maintenance of the European Medical Device Nomenclature required by the European Regulations for Medical Devices (2017/745, Art 26) and In Vitro Diagnostic Medical Devices (2017/746, Art 23) which plays a pivotal role in the implementation of the same Regulations.

From the Italian classification to the European nomenclature

The European Commission in 2019 announced the adoption of the Italian classification system, the National Classification of Medical Devices - CND, as the basis for the future European nomenclature of medical devices (EMDN).

The Italian Ministry of Health, with the support of the Friuli Venezia Giulia Region conducted a consulation on the CND with all relevant actors and an extraordinary update of the Italian National Classification took place. The results of this extraordinary update culminated in the first version of the EMDN.

Since October 2021, the EMDN has been used for the registration of medical devices in the European database for medical devices (Eudamed).

The objectives of the SMEMDN project

The project SMEMDN will last 36 months, during which the Italian Ministry of the Health (beneficiary), with the collaboration of the Friuli Venezia Giulia Region (affiliated entity), will build on experience gained from the past three years of EMDN implementation a European level and further enhance the activities carried out for the EMDN. In particular the aim is to support the European Commission:

• in the periodic update of the EMDN
• in the communication with Member States’ authorities and stakeholders regarding needs for information and clarification on the nomenclature
• in making available tools to support the use of the EMDN
• in the support the Commission in its collaboration with the World Health Organisation

In line with the participatory policy already implemented in Italy for more than two decades in the activities of the CND update, SMEMDN involves different international stakeholders in the maintenance and improvement of the EMDN also with regard to the take in of the technological evolution of medical devices on the market.

A kick off meeting between the parties took place on19 April 2023 where objectives were discussed and roles, tasks and responsibilities for the implementation of the SMEMDN project were further defined.

For more information, see the Medical Device Nomenclature section.