Legislation and guidance on medical devices

Updated 27 January 2016

The Danish Medicines Agency administers the law on medical devices in Denmark, and we are also involved in the preparation of EU rules and guidelines in the area in relevant European working groups.

As a member of the EU, Denmark is required to follow the union rules governing medical devices. Medical devices are governed in particular by Regulation EU of the European Parliament and of the Council of 5 April 2017 and Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices.

These provisions have been transposed in the ‘Danish Act on Medical Devices’ and its associated executive orders on medical devices.

This is a framework act that authorises the Minister for Health to lay down the rules necessary for the implementation and application of the European Union’s provisions on medical devices.

The Danish Act on Medical Devices governs two main areas each with their own executive order.

Executive order no. 957 of 29 April 2021 on medical devices and products without a medical purpose (in Danish only)

Executive order no. 1269 of 12 December 2005 on in vitro diagnostics medical devices (in Danish only)

The two executive orders implement the EU rules on medical devices in Danish law. In addition to the two executive orders, other legislation involves medical devices. We have gathered the acts, executive orders and circulars applicable in the area of medical devices under Legislation.

The legislation evolves continuously in a collaboration between the authorities in the EU, representatives from the industry, scientific societies, patient organisations and others. In addition, the European Commission develops guidelines in the area in collaboration with the authorities, scientific societies and industry representatives.

Supplementary to this, the Danish Medicines Agency has issued guidelines in the medical devices area for users, healthcare professionals and medical devices companies to help them understand the requirements of the law.

Harmonised standards provide methods to document that medical devices comply with the essential requirements of the law. We have complied at list of harmonised standards applicable to medical devices. The list is in Danish only.

The general requirements of the act

The rules governing medical devices stipulate that medical devices must bear CE marking when marketed. The CE marking is the manufacturer’s certification that the medical device complies with the EU legislation in force.

The Danish Act on Medical Devices contains provisions to be followed by the manufacturer responsible for putting the product on the market. The manufacturer must establish a surveillance system to record and prevent device incidents and accidents. The manufacturer must collect and process experiences with the medical device both from production and from those who use the device.

In addition, manufacturers, importers and distributors of medical devices and healthcare professionals are required to report serious incidents and accidents with medical devices to the Danish Medicines Agency.

The act also describes the authorities’ market surveillance responsibility. In this connection, the Danish Medicines Agency monitors the Danish market and follows up on device incidents and accidents for causes to be investigated and actions taken. The Danish Medicines Agency is in contact with the European Commission and other authorities and exchanges information on medical devices and safety related matters.

The schedules to the act describe the general provisions on the essential requirements for product quality and safety. The schedules furthermore describe the conformity procedures that manufacturers must follow in connection with marketing of the products.

The schedules also describe the provisions to be followed by the notified bodies responsible for medical device certification.

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