When must healthcare professionals notify DHMA of a clinical investigation for a medical device
Medical devices are products used for the treatment of humans and cover a wide range of products; up to half a million different products. Medical devices are used for the diagnosis, treatment or easement of a disease, disability and injury.
Moreover, medical devices also cover implants used for cosmetic purposes and pregnancy prevention products. Contrary to medicinal products, medical devices are not absorbed in the organism and do not have a pharmacological, metabolic or immunological effect.
Medical devices must be CE marked to prove that the device meets the legal requirements for safety and performance.
The purpose and use of the device appear from the product labelling and the instructions for use as well as advertising material.
You must notify the Danish Medicines Agency of a clinical investigation for a medical device if one of the following criteria exist:
- the device is not CE marked
- the device is to be used for another purpose than the purpose CE marked by the manufacturer, see the device's labelling and instructions for use.
If a CE marked device is to be used as specified on the product's labelling and instructions for use in a clinical investigation, the investigation should not be notified to the Danish Medicines Agency. But all clinical investigations for medical devices – CE marked and non CE marked - must be notified to a research ethics committee.
Medical devices are not subject to a central regulatory approval; consequently, the manufacturer of the device has the information about the documented purpose.
Contact the manufacturer/distributor if you are in doubt about whether the product's intended purpose is CE marked.