How to select the appropriate EMDN code for stand-alone medical device software?

Question

I need to register a stand-alone medical device software in EUDAMED and am uncertain which EMDN code to use. V92 - MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES seems relevant, but the EMDN system is complex and I am unsure if other, more specific codes for software apply. Can anyone clarify if V92 is generally accepted or if there are additional codes to consider for stand-alone software?

Dr. Oliver Eidel · Accepted Answer

We classified our stand-alone software under V92 as well, and our Notified Body accepted it. It's a fairly common choice for software that doesn't fit into other specific categories. Just make sure your software truly doesn't fall under one of the more detailed codes related to its intended use.

Answer

Depending on the intended use, you might want to consider codes like Z12040192 (GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE). Check if your software fits a more specific category before defaulting to V92.

Answer

There is more software hidden under other codes, but only if the higher level categories fit your product. For example, if your software fits under a general medicine instrument category, those codes might apply. For purely stand-alone software, V92 is usually appropriate. Future EMDN versions might add subcategories to V92.

Answer

We just registered our stand-alone software in EUDAMED using V92.

How to select the appropriate EMDN code for stand-alone medical device software?

4 Answers

Keep reading

Medical Device Codes: EMDN, UMDNS, GMDN and MDR

How to find UMDNS and GMDN codes for SaMD?

Writing An Intended Use for Software as a Medical Device