Medical devices are products which are used for the diagnosis, prevention, relief or treatment of a disease, disability, injury etc. Medical devices cover a wide range of products, including wheelchairs, glasses, pacemakers, dental crowns and hip implants.
Medical devices are not authorised by the Danish Medicines Agency. They must be CE marked, before they are placed on the market. The Danish Medicines Agency is surveying the safety of medical devices. For example, by receiving incident reports concerning medical devices.
Incident reporting form for healthcare professionals and users (in Danish only)
Safety and marketing
The manufacturer is responsible for CE marking the product and product safety.
Medical devices are divided into four classes: I, IIa, IIb and III. The classification rules are based on the vulnerability of the human body taking account of the potential risks associated with the technical design and manufacture of the devices. Class I is associated with the lowest risk, while class III is associated with the highest risk. For example, walking frames are classified as class I, whereas breast implants are class III devices.
For products classified higher than class I, the manufacturer must choose a notified body to review the product documentation. The notified body issues a certificate if the product documentation meets the requirements. The certificate is part of the manufacturer's documentation for the product's safety and CE mark.
Danish companies that market medical devices must register with the Danish Medicines Agency.