Service Number - Labelling

CraigRegulatory

Starting to get Involved
Hi all,

We are a non-EU manufacturer selling active devices into Europe. We currently manually add a label with the phone number of our service department. We would like to change this from a label to a QR code which links to a page with the same info but also additional questions that the user needs to complete so that we have all the information we need to respond to their service query/complaint.

Is there anything stopping us from doing this?

Nothing in the MDR (to me) seems to indicate the need for a phone number, just address. I hope I'm right and that there are no issues with doing this.

Thanks
 

EmiliaBedelia

Quite Involved in Discussions
I believe the requirement is to have the service contact information in the IFU, but not on the label.

Since there's no regulatory requirement to have the information, I wouldn't see an issue with using a QR code.
 

CraigRegulatory

Starting to get Involved
So to confirm:

We can choose to exclude a label with the contact details in both the IFU and label - and have a QR code in both?

Thanks again
 
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