Hello,
I am wondering if manufacturer contact data are mandatory on medical device label, and if yes, which of them?
We are considering cooperation with a specimen collector manufacturer, who offered to adjust their current label on medical devices. Currently, they have a lot of contact information on the label (telephone, fax, email, website), and we wanted to remove it. Can this be done, though?
I looked through IVDR, and in Annex I, article 20.2, it says, "The label for devices for self-testing shall bear contact details for further advice and assistance".
But is a saliva collector classified as a "self-testing" device? Its intended purpose is for a user to collect saliva at home and ship the sample back by post.
I did not find "provide manufacturer contact data" anywhere else in IVDR.
I am wondering if manufacturer contact data are mandatory on medical device label, and if yes, which of them?
We are considering cooperation with a specimen collector manufacturer, who offered to adjust their current label on medical devices. Currently, they have a lot of contact information on the label (telephone, fax, email, website), and we wanted to remove it. Can this be done, though?
I looked through IVDR, and in Annex I, article 20.2, it says, "The label for devices for self-testing shall bear contact details for further advice and assistance".
But is a saliva collector classified as a "self-testing" device? Its intended purpose is for a user to collect saliva at home and ship the sample back by post.
I did not find "provide manufacturer contact data" anywhere else in IVDR.
