EMDN Helpdesk

The EU Commission’s EMDN helpdesk is now live: HERE

As noted previously, it requires that users create an account to use the system. The process is straightforward: 1) click “register” at the bottom of the sign-in screen, 2) enter your name, email address, and other details, 3) click the link in the automated email to verify your account.

During the Commissions’ EMDN training yesterday, they stated they would aim to respond to questions within one week; however, that the timing would ultimately depend on the number of inquiries received.

The system’s user manual is located here. It details how to submit inquiries, e.g., requesting advice on which code to assign to your device.

Note that the Helpdesk also includes ‘Knowledge Base’ and ‘FAQ’ sections (see image below).

MedTech Europe’s Guidance

MedTech Europe published a ‘Practical guide to the use of the European Medical Device Nomenclature (EMDN)’: HERE

In addition to background on EMDN codes, it provides tips on code selection. For example, if you manufacture products that fit under ‘Category K – Endotherapy and electrosurgical devices’, it notes that certain product types should apply ‘Category L – Reusable surgical instruments’ codes instead (see image below).

Additional EMDN Resources

Further, links to the EMDN database, helpdesk, and associated guidance are maintained at Casus Resource: Regulations & Guidance Documents