Label requirements of CE marked device during clinical investigation

[DannyVerbiest]

Hi everyone!
I have 2 label related questions for a CE (MDR) approved class IIb medical device during clinical trials.

1) Does my investigational device (in this case a CE-marked device) still require "exclusively for clinical investigation" on its label?
Does it impact whether the device will be used within or outside the CE-approved intended purpose scope?

2) Does the clinical trial reference need to be listed on the label for traceability purposes?

Thanks for your input!

 

[Raisin picker]

If the device is CE approved, you do not need the CI label (PMCF trial), as long as you stay within the certified intended purpose. If the device is not used within the certified intended purpose, the device is not CE certified, thus it needs the label.

You are required to identify possible systematic misuse or off-label use (MDR Annex XIV (6.1.e)), and you surely don't want to be the source of that off-label use.

For question 2, I have no idea.

 

[DannyVerbiest]

Thanks, raisin picker!

Just a quick note for the silent readers who might be following this thread:
In the meantime, I’ve been able to confirm raisin’s reply to my initial question. The exemption was stated in ISO 14155, section I.7, which lists the situations where the ISO labelling requirements are not applicable.