At medicaldevices.dk, you can find our information about medical devices and possibilities for submitting electronic reports.
Medical devices are products which are used for the diagnosis, treatment or easement of a disease or disability in human beings. Basically, this means everything from injection needles, surgical instruments, artificial hips and pacemakers to wheelchairs, glasses and the like.
Our monitoring of medical devices
The Danish Health and Medicines Authority monitors medical devices on the Danish market. For example, we assess accidents with medical devices and inspect Danish device manufacturers. Hospitals, other healthcare establishments and manufacturers have a duty to report accidents that involve medical devices.
Medical device manufacturers
The medical device manufacturer is responsible for the safety and performance of the device once it is on the market. By law, the device manufacturer must report to the Danish Health and Medicines Authority any device malfunction or deterioration in the function or performance of the device.
Incidents with medical devices
Incidents with medical devices must also be reported to the Danish Health and Medicines Authority. You can do so using the reporting form for incident reporting on our subsite www.medicaldevices.dk.
You can also use a special Danish e-form for reporting problems associated with the use of medicine, medical devices or suspicion of drug abuse: Problemer ved brug af medicin, medicinsk udstyr eller mistanke om misbrug (e-blanket)
Our other tasks in relation to medical devices
We offer guidance and information to manufacturers and users, review reports from the authorities in the other EU countries, participate in EU initiatives, give advice to the Danish Ministry for Health and Prevention and issue free sales certificates.
We review applications to test medical devices in clinical trials and inspect these trials.
