Medical devices used for animals
The Danish legislation and EU directives on medical devices only include medical devices for human beings. Medical devices for veterinary use are not included in the legislation and therefore there is no requirement that they must be CE-marked as medical devices or meet the requirements for the CE marking.
Medical devices intended for human beings must be CE-marked, and these devices are still covered by the legislation on medical devices when used for veterinarian use.
If the manufacturer becomes aware of a safety related issue with the CE-marked medical device the subsequent corrective action (FSCA) must also be performed on devices that are provided to veterinary settings.
The Danish Medicines Agency does not issue export certificates for medical devices for veterinary use. You can contact the Danish Veterinary and Food Administration for further information. You can find the contact information at www.foedevarestyrelsen.dk