07.06.2021
To the attention of Romanian manufacturers of medical devices/authorised representatives
European Medical Device Nomenclature (EMDN)
We inform you that starting from 04.05.2021, the European Medical Device Nomenclature (EMDN), as defined by Article 26 of the Medical Device Regulation (EU) 2017/745 (MDR) and Article 23 of the Medical Device Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), its platform and the English translation validation consultation are officially posted online: https://webgate.ec.europa.eu/dyna2/emdn/.
The Italian version of the nomenclature is deemed final and official. The English version is subject to validation through this online consultation for one month.
The EMDN is used by manufacturers to register medical devices into the EUDAMED, where each device will be associated with each unique device identifier – device identifier (UDI-DI). The EMDN is intended to support all actors in their activities under MDR / IVDR and provides key descriptions of medical devices.
EMDN is characterised by its alphanumeric structure which is established in a multi-level hierarchical tree. It groups medical devices into three main tiers. The first hierarchical level is the “Category” level, the second is the “Group” level, and the third is the “Type” level.
Each medical device is classified by an alphanumeric code containing a letter referring to “Category”, 2 numbers referring to “Group” and between 1 and 5 two-digit numbers referring to “Type”, up to a maximum of 7 levels of detail.
There are 22 categories for the first hierarchical level “Category”. Each is identified by a letter of the alphabet. Each category includes devices regulated in the MDR or IVDR. The categories are divided into 8 anatomical categories.
The second hierarchical level “Group” contains 146 groups of anatomical / functional medical devices. These are the differentiations to distinguish between devices in these categories and are identified by two-digit numbers from 01 to 99 for each category. Number 90 identifies groups of devices which possess various characteristics not related to the existing groups, while number 99 (“other”) is reserved for medical devices which are not included in the already existing groups and which shall be classified in future updates.
“Type” represents the third hierarchical level. It can be expanded to 7 levels of detail, each defined in the code by a two-digit number. Each type level includes medical devices characterised by a high affinity for use, intended use, or a similar clinical method.
As regards accessories, each accessory will inherit the EMDN classification code of the medical device with which it is associated. If the accessory can be used with several devices belonging to different groups, it will be assigned the predominant type code.
Although the EUDAMED is not yet fully operational, implementation of the first module on actor registration started in December 2020, while the second module for UDI registration was announced for September 2021. Manufacturers are therefore advised to already start preparing for these EUDAMED registration requirements in order to be ready to submit the requested information as soon as the various database modules become operational.