EMDN Codes / DOC

[Amy Elizabeth]

Hello,

I have just started at a new company and am in the process of updating their DOC's to include the UDI and EMDN codes.

in some instances there are multiple EMDN codes listed under one DOC for various product codes under the same Basic UDI/Technical File

Does anyone know if this is ok, or should there only be one EMDN code per family group/Technical File?

 

[Cloud808]

It is acceptable (in my experience) to have multiple EMDN codes on a single DoC, in much the same way that it is acceptable to have multiple devices within a single technical file (so long as the grouping of devices is logical, based on having the same product codes or similarity of design, intended purpose, etc.).

A device model should only have 1 Basic UDI as well as 1 EMDN code attributed to it. It may be the case that all devices within a device family / technical file have the same EMDN, but it may also not be the case, dependent upon your grouping of devices. In my case, we have created technical documentation in which products with different EMDN codes and MDN/MDA codes are grouped. There is not a great deal of variance, but some based on each device's intended purpose.

There are a great many explanatory documents on the commissions guidance page, here: Guidance - MDCG endorsed documents and other guidance

In particular, MDCG 2018-1 & MDCG 2021-12 should be of interest to you.