Manufacturers of medical devices

Updated 04 March 2019

The following companies are required to register with the Danish Medicines Agency if they are headquartered in Denmark:

  • Manufacturers of class I devices
  • Manufacturers of class IIa and IIb devices
  • Manufacturers of class III devices
  • Manufacturers of active implantable medical devices
  • Manufacturers of in vitro diagnostic medical devices
  • Manufacturers of custom-made devices
  • Manufacturers of system 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 requirement to register also applies to Danish representatives of manufacturers outside the EU.

Companies that are both manufacturers and importers and/or distributors

A company that is both a manufacturer of a medical device and an importer and/or distributor of another medical device must pay both an annual fee as a manufacturer pursuant to the rules of the executive order on fees payable for medical devices and an annual fee as an importer/distributor pursuant to the executive order on fees payable by importers and distributors of medical devices.

Form

Register company by clicking here (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.

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.

Use the list of devices if you want to register class I devices or system and procedure packs. Please submit a list of devices if you market and sterilise devices that are marketed as non-sterilised by the manufacturer, but intended to be sterilised before use.

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

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 and riskclasses. The fee appears from the executive order on fees which is updated annually.

Annual fees for manufacturers 2019

Low risk (class I, IVD and by measure) 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

 

High risk (class IIa, IIb, III and AIMD) Annual fee
 0-9 employees DKK 21,609
 10-19 employees DKK 45,969
 20-49 employees DKK 94,690
 Over 49 employees DKK 216,490

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 medical devices in the European Database of Medical Devices (EUDAMED). This applies to information on class I medical devices, IVD, system and procedure packs and devices that are marketed as non-sterilised by the manufacturer, but intended to be sterilised before use.

Information about specialised stores, manufacturers of active implantable devices, custom-made devices and class IIa, IIb and III devices are not entered in EUDAMED. EUDAMED is not a publicly available database, and only European authorities have access to the database. These devices are registered with notified bodies in Europe.

The obligation to register appears from legislation

The requirement to register is laid down in the executive order on medical devices no. 1263 of 15 December 2008, 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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