Need for special Labeling?

I am sending a brand new prototype (A new medical device) to one of our users at the EU by shipping company (FedEx, USP…).

The Prototype can not be operated at any case
It did not pass any Safety approval yet


Do I need to add special Labeling?
Special User-Manual.

Need you advise.

Nissim Shaked

The Medical Device Directive states (Article 4, Paragraph3) that "At trade fairs, exhibitions, demonstrations, etc. Member States shall not create any obstacle to the showing of devices which do not conform to this directive, provided that a visible sign clearly indicates that such device cannot be marketed or put into service until they have been made to comply"

So if you clearly label the device as described ther should not be a problem.

Thanks
Your help is highly appreciated

Nissim Shaked

Simply - do not affix the CE mark. We also add the phrase "not for clinical use".