Denmark Medical Device Registration

Navigating Medical Device Registration in Denmark: Insights from the Danish Medicines Agency and Latest Regulatory Trends

Regulatory Authority

Danish Medicines Agency

Link for Regulatory Authority 

https://laegemiddelstyrelsen.dk/en/

Local Regulation

• EU MDR
• Danish Act on Medical Devices

For medical devices with no medical purpose Act 957 of 2021 Product Safety Act (16 Dec. 2000) Order No. 1263 on Medical Devices (15 Dec. 2008) Order on Importers and Distributors of Medical Devices, Executive Order No. 1460 (18 Dec. 2014)

Classification

Class I, IIa, IIb, III

Registration Requirements

All medical devices marketed in Denmark, or any other European Union country, must be CE marked. A CE mark is a sign of compliance with EU medical device regulations and allows the device to be freely distributed within all EU member states. For a medical device belonging to Classes IIa, IIb, or III, it is required that a Notified Body assess the safety and performance of the device prior to granting a CE marking.

The length of the registration process can vary and mostly depends on the class of the device. For example, for Class I devices, the process is usually relatively quick and takes, on average, from 4 to 6 weeks. If manufacturers plan to continue to market their device in either Denmark or the EU, they must submit a renewal application

No authorisations are required from the DMA to manufacture, import, export or conduct wholesale distribution and storage of medical devices. However, registration with the DMA is required.

Registration Timeline

The registration process takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device.

Registration Fee

The Danish Medicines Agency charges two annual fees and one registration fee. The registration fee is equal to either 1,159 DKK ($176 USD) for manufacturers or 1,147 DKK ($175 USD) for importers and distributors. The two annual fees vary depending on the class of the device and number of manufacturer representatives registered in the Danish Central Business Register on January 31 of each year.

Renewal Before

9 months

License Validity

5 years

Special Labelling Requirements

There is an obligation to provide labels and IFUs in the Danish language whenever the device is made available to the end-user or patient in Denmark.

Additional Comments

CE marking on a medical device signifies that the device meets the requirements of the executive order and that it has been subjected to a conformity procedure. In the case of class IIa, IIb and III medical devices, the CE marking must be accompanied by an identification number of the notified body.

CE marking must be affixed to the instructions for use, the device itself or in the case of sterile devices on the sterile packaging. If possible, the CE marking must also be affixed to the sales package. Before any of these measures, the manufacturer should first determine if the product is a medical device.

On April 5, 2017, two new Regulations on medical devices were adopted, these entered into force on May 25, 2017 and replaced the existing Directives. The new rules will only apply after a transitional period, namely, 3 years after entry into force for the Regulation on medical devices (spring 2020) and 5 years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices.

Market Sector

Denmark’s Other Medical Devices market is poised to reach a revenue of US$0.52 billion in 2024. Looking forward, the market is projected to demonstrate an annual growth rate (CAGR 2024-2028) of 3.21%, resulting in a market volume of US$0.59 billion by 2028. . Denmark’s dynamic medical device sector is actively fostering innovation, emphasizing the development of cutting-edge technologies for diverse non-traditional medical applications.

Additional Danish registration requirements only concern companies that are headquartered in Denmark.