On 20 March 2023, the SMEMDN – Supporting the maintenance of the European Medical Device Nomenclature project was launched, within the framework of the European Union (EU) EU4Health 2022 programme.
The project defines the activities necessary for the support and maintenance of the European nomenclature of medical devices required by Regulation (EU) 2017/745 on medical devices (art. 26) and by Regulation (EU) 2017/746 on medical diagnostic devices in vitro (art. 23) and which is of fundamental importance in the application of the same Regulations.
From the Italian classification to the European nomenclature
In 2019, the European Commission 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, European Medical Device Nomenclature – EMDN.
The Italian Ministry of Health with the support of the Friuli Venezia Giulia Region conducted a consultation on CND with all relevant actors and oversaw an extraordinary update of the Italian National Classification. The results of this extraordinary update gave rise to the first version of the EMDN.
Since October 2021, the EMDN nomenclature is used for the registration of medical devices in the European medical device database (Eudamedus).
The objectives of the SMEMDN project
The SMEMDN project will have a duration of 36 months in which the Italian Ministry of Health (beneficiary), with the collaboration of the Friuli Venezia Giulia Region (affiliated body), will build on the experience gained over the last three years of EMDN implementation at European level and will enhance the activities carried out for the EMDN.
In particular, the goal is to support the European Commission:
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in the periodic updating of the EMDN
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in communicating with Member State authorities and stakeholders regarding information needs and clarifications on nomenclature
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in making available tools to support the use of the EMDN,
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in collaboration with the World Health Organization.
In line with the participatory policy already implemented in Italy for more than two decades in the implementation of the updating of the CND, SMEMDN provides for the involvement of the various stakeholder international organizations for the maintenance and improvement of the EMDN also as regards the implementation of the technological evolution of the medical devices present on the market.
On April 19, 2023 the Kick off meeting Between the parts, during which the objectives were discussed and the roles, tasks and responsibilities for the implementation of the SMEMDN project were further defined.
For more information, see the Medical Device Nomenclature section