Registration and marketing
Manufacturers, EU representatives, importers and distributors of medical devices and specialised stores are required to register with the Danish Medicines Agency. The registration helps us offer guidance to companies, monitor the market and process incidents, all of which contribute to promoting patient safety.
The following companies must register with the Danish Medicines Agency if headquartered in Denmark:
- Manufacturers of medical devices in classes I, IIa, IIb and III, active implantable medical devices (AIMD), custom-made devices as well as systems and procedure packs. Companies sterilising and marketing CE marked devices that are marketed as non-sterilised by the manufacturer but intended to be sterilised before use. The duty to register also applies to Danish representatives of manufacturers outside the EU.
- Manufacturers of in vitro diagnostic devices (IVD).
- Distributors and importers of medical devices.
- Specialised stores are stores specialising in the sale of medical devices in risk classes IIa, IIb and III, active implantable medical devices and in vitro diagnostic medical devices. To be considered a specialised store, the above-mentioned types of medical devices must comprise at least 50% of the store's sales. For example, the stores may specialise in the sale of hearing aids or contact lenses.
We will send an acknowledgement when we have completed the registration.
We charge a registration fee and two annual fees according to the applicable executive orders on fees.
- The registration fee amounts to DKK 1,175 for manufacturers of class I devices, custom-made devices, in vitro diagnostic devices (IVD) and systems and procedure packs.
- The registration fee amounts to DKK 1,175 for importers and distributors.
In addition, we charge two annual fees. One annual fee is determined based on the risk class of the device and number of employees registered in the Danish Central Business Register at 31 January in the year concerned. The other annual fee is charged for the implementation of EU regulations on medical devices regardless of risk class and number of employees.
No annual fees are charged for specialised stores.
Companies are only allowed to market medical devices if they comply with the requirements laid down in the executive orders on medical devices. Further, it is important to pay attention to the rules governing advertising and relationships when collaborating with healthcare professionals.