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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 European Medical Device Nomenclature (EMDN) aims at supporting the functioning of the European database on medical devices (EUDAMED).

The website of the European Union displays the most up to date of the European Medical Device Nomenclature (EMDN):  European Medical Device Nomenclature (EMDN).

The Medical Device Coordination Group (MDCG) at its meeting of 14 February 2019 decided to identify the Italian classification of medical devices, the National Classification of Medical Devices (CND), as a basis for the implementation of the EMDN nomenclature, in reason of its structure, purposes, usability and updating methodology.

The Italian Working Group (Medical Device Technical Team), with the support of representatives of trade associations, experts and users operating in the National Health Service, has drawn up a proposal, presented to the Nomenclature Working Group during the meeting of 30 April 2021.

During the meeting the Nomenclature working group expressed great satisfaction for the work done by Italy and approved the final and official EMDN version in Italian and the draft of the EMDN in English.

On May 4th 2021, the final and official Italian version of the nomenclatore EMDN and the draft of the English version were published.

A consultation is currently ongoing by the European Commission on the English version of the EMDN nomenclature, available on the page: European Medical Device Nomenclature (EMDN).

To find out more information see the following pages on the Commission’s website:



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On March 20th 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 began.

The project defines the activities necessary for the support and maintenance of the European Medical Device Nomenclature provided for in Regulation (EU) 2017/745 on medical devices (Art. 26) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (Art. 23) and it plays a pivotal role in the implementation of the same Regulations.

From Italian classification to European nomenclature

In 2019, and following the agreement of the Medical Device Coordination Group (MDCG), the European Commission announced the adoption of the Italian classification system, Classificazione Nazionale dei Dispositivi medici - CND, as the basis for the future European medical device nomenclature (EMDN). Following this decision, during the three-year period 2018-2021 the Italian Ministry of Health, with the support of the Autonomous Region of Friuli Venezia Giulia contributed to the release of the first version of the EMDN in Italian, which was subsequently made available to stakeholders on the European Commission website and within Eudamed. Based on the long experience of the Ministry of Health, with the collaboration of the Friuli Venezia Giulia Region in managing and updating the CND and converting it into the EMDN, the European Commission, through a direct grant proposal to member state authorities (HS-g-22-19.02 ), allowed the Italian Ministry of Health to continue to provide support and expertise gained in maintaining the EMDN.

In view of the pre-existing collaboration regarding the management and updating of the Italian nomenclature, the consortium formed for the implementation of the SMEMDN project is composed of the Italian Ministry of Health, as beneficiary, and the Autonomous Region of Friuli Venezia Giulia, as affiliated entity.

Funding

The project is co-financed with resources from the Italian Ministry of Health and the European Commission under the European EU4Health Programme (EU4H) 2022-CUP J99B23000010006

Objectives and structure

During the 36 months' project lifespan, these are the objectives to be reached:

  • to provide support to the European Commission in communicating with member state authorities and stakeholders regarding nomenclature information and clarification needs;
  • to maintain and periodically update the nomenclature;
  • to update tools to support the use of EMDN;
  • to support the Commission in its collaboration with the World Health Organization.

The SMEMDN project is organized into 5 work packages (WPs), each one with specific objectives:

  1. WP1 Management and Coordination (WP leader Ministry of Health): aimed at managing and coordinating the dissemination, activities and results of the project;
  2. WP2 Communication and Dissemination (WP leader Friuli Venezia Giulia Region): includes communication and training activities with member state authorities and stakeholders to respond to requests for information and clarification on the nomenclature, publicly present information about the project, and support collaboration between the European Commission and WHO;
  3. WP3 Evaluation (WP leader Ministry of Health): participation in the activities planned in the other WPs and the set of actions to evaluate the quality of the results produced;
  4. WP4 Sustainability (WP leader Friuli Venezia Giulia Region): ensures that the results produce the expected impact and benefits, even at the end of the 36-month project duration;
  5. WP5 EMDN Management (WP leader Friuli Venezia Giulia Region): concerning technical/operational activities on EMDN such as updating the nomenclature and developing tools to support its proper use.

The kick off meeting took place on April 19th, 2023. During this meeting, details about the project were shared by the European Commission and the consortium.

Among the expected outcomes:

  • the establishment of a helpdesk platform to support stakeholders;
  • the organization of training workshops in order to promote the correct use of the nomenclature;
  • the annual updating of the EMDN in order to ensure its continuous improvement and the incorporation of technological evolution of medical devices in the market.

Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or European Health and Digital Executive Agency (HaDEA). Neither the European Union nor the granting authority can be held responsible for them.

 


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Data di pubblicazione: 22 maggio 2023, ultimo aggiornamento 1 dicembre 2023

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