EMDN codes

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). 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 Unique Device Identifier – Device Identifier (UDI-DI).

As the EMDN primarily serves regulatory purposes to support MDR and IVDR requirements, it also 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. It is intended to support all actors in their activities under the MDR/IVDR and provides key device descriptions to patients as regards their own devices and all other devices available on the market and registered in EUDAMED.

According to criteria and requirements set out by the European Commission and EU regulators in the Medical Device Coordination Group (MDCG) and based on orientations provided by the MDCG, 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.

At that time, the CND was already utilised in three Member States (Italy, Greece and Portugal) and supported the registrations of a variety of EU and international manufacturers within the EU.

During the course of 2019 and 2020, consultations and preparatory work on the CND took place with stakeholders and key experts. A first version of the EMDN was released on 04 May 2021.

The EMDN is based on fundamental key principles jointly set out by the European Commission and EU regulators. These principles include but are not limited to:

The EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree. It clusters medical devices into three main levels:

Each alphanumeric code begins with a letter referring to the Category for which the device falls under, followed by two numbers indicating the Group and a series of numbers which refer to the Type. The maximum number of digits is set at 13.

The entirety of the EMDN is accessible to all stakeholders, free of charge. It can hence be utilised by a non-exhaustive list of stakeholders such as manufacturers, patients, research organisations, practitioners, hospitals, pharmacies etc. The EMDN can be accessed and downloaded in pdf and excel format at webgate.ec.europa.eu/dyna2/emdn and the European Commission’s website page for MDCG documents.