CE Mark requirements on US Clinical Trial Product

redman5 · #1 16th February 2012, 04:36 PM

We have a product that is CE approved and we are starting US clinical trials. The question is do we need to cover the CE mark on the US clinical packaging or product?

**Stijloor** · #2 17th February 2012, 02:50 AM

A Quick Bump!

Can someone help with this?

Thank you very much!!

Stijloor.

**sreenu927** · #3 16th August 2012, 11:12 PM

If approved in EU, you will have CE marking- this is clear.

When the same instrument is used for US Clinical trials, you can't update the existing label (for EU registration) and use it for US IDE/Clinical trials.

You need to create another label with IUO symbol or IUO/IDE wordings on that. So the CE marking is not required to have on this label.

Regards,
Sreenu

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