Manufacturers of in vitro diagnostic devices (IVD)

Updated 01 January 2019

Danish manufacturers and EU representatives of in vitro diagnostic devices are required to register with the Danish Medicines Agency if they are headquartered in Denmark.

Use the form below for the registration of IVD if you want to register devices or information on certificates.

Log in by using your business NemID. You will receive an acknowledgement when we have processed the registration. It may take up to 14 days.

If an error message appears, the Danish Central Business Register may not have any information about the number of employees in the company. It is not possible to access the form. Please send an email to mu-fab@dkma.dk, then we will send a form to you.

Form

Register company and devices (in Danish, opens in a new window)

Note: You have 20 minutes to complete and submit the form after you have opened it. If you spend more time, we will not receive your form.

Fees

We charge a fee for the registration. The fee amounts to DKK 1,159 for manufacturers.

We charge an annual fee based on the number of employees registered by the Danish Central Business Register at 31 January in the relevant year. The fee appears from the executive order on fees which is updated annually.

Annual fees for manufacturers 2019

IVD, all risk classes Annual fee
 0-9 employees DKK 2,056
 10-19 employees DKK 6,863
 20-49 employees DKK 16,476
 Over 49 employees DKK 40,512

We have access to more detailed information about companies and the number of employees than the information in the Danish Central Business Register.

The Central Business Register provides figures that are updated on an ongoing basis. The figures may not be updated and do not necessarily reflect the exact number of employees in the company at the time when we received the data, i.e. on 31 January in the relevant year. Nor may the data reflect the number of employees working with medical devices within the company. According to the executive order, we have to use this figure as the basis for the fee. We cannot charge the annual fee on an accrual basis.

In addition to this an annual fee is charged to cover the implementation of EU legislation on medical devices - regardless of risk class and number of employees. This fee will no longer apply after 2022.

Your registration contributes to market surveillance in Europe

We use the information to monitor the markets in Denmark and Europe. We have an obligation to enter information on IVD in the European Database of Medical Devices (EUDAMED).

The obligation to register appears from legislation

The requirement to register is laid down in the executive order on medical devices no. 1269 of 12 December 2005, the act to amend the act on medical devices no. 518 of 26 May 2014 and executive order no. 872 of 1 July 2014 on registration of manufacturers and owners of retail stores and their representatives which market or sell medical devices. You can find the executive orders under legislation.

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