Difference between "misuse" and "off-label use"

[Zero_yield]

Thought of this thread when I read this one. The European Association of Medical devices Notified Bodies put out a non-binding positional paper on off-label use that describes what off-label use is in detail for 5 pages.

 

[Aliken]

Team

Hello,
Annex XIV to the MDR states the following:


As anyone an idea why a distinction is made between misuse and off-label use? Are those terms referring to different concepts?

Hi FoGia,
To your inquiry, Team NB has recently published a position paper on off-label use, and it seems that, like in MDR Annex XVI, the terms off-label use and misuse are used as synonyms.

 

[Aliken]

Oh, I just saw Zero_yield posted the same info.