Guidance on parallel distribution of medical devices

18 January 2018, Updated 18 January 2018

This guidance provides information that parallel distributors need to know to distribute parallel imported medical devices.

If you would like to know more about medical devices, we encourage you to read our introduction to medical devices.

Guidance on parallel distribution

Requirements for labelling and instructions for use

Legislation

Guidance on parallel distribution

Parallel distribution is when a CE marked medical device, which is marketed legally in another EU or EFTA state, is imported to Denmark and redistributed with the intention of being put into service without the existence of an agreement thereon entered with the manufacturer.

Danish parallel importers are subject to the rules on distributors’ registration and reporting duties established in the executive order on importers and distributors of medical devices. Danish parallel distributors must register with the Danish Medicines Agency. This can be done on our website. In addition, Danish parallel distributors of medical devices have a duty to report serious incidents with medical devices to the Danish Medicines Agency.

A CE marked medical device is a whole and indivisible product consisting of the device itself, the labelling, packaging and instructions for use. It is the full responsibility of the manufacturer to ensure that the product as a whole complies with the requirements of the directive.

If a parallel distributor touches on the manufacturer's responsibility by changing the product or opening the packaging or some other way, the parallel distributor should be prepared to assume full responsibility for the product as a manufacturer. 

Further guidance is available in Guidance for new manufacturers of medical devices (in Danish only).

REQUIREMENTS FOR LABELLING AND INSTRUCTIONS FOR USE

The executive order on medical devices establishes that labelling and instructions for use must be in Danish when medical devices reach the end user, regardless of whether it is for professional or other use.

In exceptional cases, the Danish Medicines Agency may allow that the mentioned information is in one or more languages of the European Union except in the case of devices for self-testing.
 

The instructions for use and labelling must be in Danish when devices reach the end user in Denmark. In connection with parallel distribution, this often implies that the instructions for use and/or supplementary labelling must be enclosed in Danish. 

A parallel distributor of a CE marked medical device may, without taking full responsibility for the product as a manufacturer, enclose a Danish version of the manufacturer's original instructions for use and a supplementary label on the outer packaging so fulfilling the requirement for Danish information. In this case, the following conditions apply:

  • The Danish version of the instructions for use and labelling must contain exactly the same information as the manufacturer's instructions for use and labelling applicable at any time.
  • The manufacturer's original packaging must not be opened, and the manufacturer's original instructions for use and labelling must not be removed.
  • The parallel distributor is fully responsible for the Danish version of the instructions for use and labelling. It must be indicated clearly who is responsible for the enclosed instructions for use and the supplementary labelling.

In case the above conditions are not observed, the parallel distributor will, depending on the circumstances, be considered to fall under the executive order's definition of a manufacturer, thus being subjected to the full responsibility for the product as a manufacturer.

Legislation

Medical devices are governed by the following legislation:

The executive orders implement the EU's directives on medical devices into Danish law (Directive 93/42/EEC on medical devices, Directive 98/79/EC on in vitro diagnostic medical devices, and Directive 90/385/EEC on active implantable medical devices)