Registration and marketing

Updated 26 November 2021

A medical device may be placed on the Danish market, distributed or put into service only if it complies with the Danish executive order on medical devices. The medical device manufacturer is responsible for the safety of the product once it is placed on the market.

Medical devices are not subject to authorisation by the authorities before marketing.

Medical devices must bear CE marking

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.

Classification

The device should be classified according to the rules applicable to the product and which appear from Schedule IX of the executive order.

Risk analysis

The individual product’s risk analysis provides the basis for a systematic control of the product’s risks. The product’s construction, manufacturing process, label and instructions for use are based on the risk analysis; the risk analysis is a central instrument to improve the safety of the product after it has been placed on the market.

Conformity procedure

It should be ensured that the product complies with the requirements of the law, including the significant requirements provided in Schedule I of the executive order. This means that the company must prepare documentation to demonstrate that the device meets the legislation’s requirements – the documentation includes risk analysis, surveillance system, certificates and clinical evaluation.

The extent of the conformity procedures depends on the risk class of the device.

In the case of devices placed in a higher risk than class I, the manufacturer must choose a notified body for the review of their product documentation. This has to be a notified body appointed by the authorities. The notified body issues a certificate if the documentation meets the requirements. The certificate is part of the manufacturer's product safety documentation. 

Market surveillance

A functioning surveillance system should be established. The system is to ensure that information on the use and safety of the device is received and processed systematically after placement on the market. This enables an identification of needed product improvements.

The surveillance system is also to ensure that serious incidents and field safety corrective actions are reported to the authorities.

The manufacturer is also required to carry out product changes in order to minimise any risks associated with the product. Risks must be included in the manufacturer’s risk analysis.

Declaration of conformity

A declaration of conformity should be prepared to certify in writing that the product complies with the law. CE marking can be affixed to the product once the relevant procedures have been completed and are legally compliant.

Incident reporting

Manufacturers are required to notify the authorities of serious device incidents and field safety corrective actions.

The Danish Medicines Agency ensures the receipt and investigation of information on serious device incidents.

All Danish importers and distributors of medical devices are required to report serious incidents to the Danish Medicines Agency.

Advertising

Advertising of medical devices must be adequate and factual. The information given in an advertising for a medical device must conform to the device’s intended purpose and field of application and must be documented.

The Danish advertising order lays down rules and requirements for advertising of medical devices, including rules on the financial benefits that companies are permitted to offer healthcare professionals and other professionals. In our guidance notes for advertising, etc. of medical devices we describe the definitions, rules and prohibitions. The guidelines are in Danish only.

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