EMDN Working Group Meeting Minutes

The EMDN working group published the minutes from their 13 November 2024 meeting: HERE

In it they discuss:

• The EMDN Help Desk will go live at the end of 2024/beginning of 2025.
• Issues around the use of EMDN code “99” (other), which should only be used when a more specific code is not yet available.
  • 80,000 EUDAMED registrations are using “99” codes, which are now undergoing preliminary review. The team has assessed potential misuse of this code type and evaluations are being prioritized by risk class.
  • Due to the high volume of cases, code miscategorizations will not be communicated directly to the manufacturer. Instead, misuse of “99” codes will be provided in general guidance, FAQs, or other resources.
• MeDevIS version 2.0 will soon be launched. This is the device database hosted by the WHO, and the device entries contain both EMDN and GMDN codes. It therefore acts as a resource for EMDN/GMDN mapping. MeDevIS is supported by the European Commission and EMDN Technical Team “to ensure accurate and representative EMDN codes are added to MeDevIS 2.0”.

EMDN Training Materials

As reported here, the MDCG hosted a training on EMDN codes on 12 November 2024. The presentations are now available: HERE

Below we recap some key points from the training.

Codes for ‘Various’, ‘Other’, and ‘Accessories’

• The number “90” (various) identifies the groups containing devices with various characteristics, not specifically included in another existing code
• EMDN codes ending in “99” (others) are dedicated to medical devices not included in already existing groups
  • This code allows manufacturers to register their device in EUDAMED, even if a code for that product is not yet available
  • Products under this category will be grouped in later updates, i.e., the devices registered under codes ending in “99” will be continually assessed by the EMDN Technical Team to help determine if EMDN codes should be newly created, split, etc.
• The number “92” is for standalone medical device software
• The numbers “80”, “82”, and “85” identify accessories (except when the accessory can be more appropriately identified by a specific code)

See below related screenshots from 1) the training presentation, and 2) the active EMDN database showing the use of EMDN codes under “80”, “90”, and “99”.

Update on EMDN Helpdesk

As noted in the EMDN Working Group meeting minutes, the Helpdesk is scheduled to go live early 2025.

The purpose of the helpdesk is to “assist in selecting the code to assign to your device”. This includes providing clarifications on the appropriate EMDN code for a medical device or IVD, the EMDN structure, and EMDN categories, groups, or types. However, the ultimate responsibility for selecting the appropriate code still rests on the manufacturer.

The helpdesk will also have an FAQ and knowledge center, with tips such as the EMDN code for IVDs will always start with “W”.

Users will be required to register in order to use the EMDN Helpdesk. See related screenshots below.

How to Choose an EMDN Code

The training also provides examples of how to find and choose an appropriate GMDN code. This includes the proper use of codes ending in ‘99’ (other) and when multiple codes are applicable to a device.

One of the examples is related to a COVID-19 Antigen Test. Since there is no code specifically for coronavirus, the appropriate code is the one ending in ’90’ (various) + ‘99’ (other): W0105099099