Requirements for labelling, language and instructions for use

The Danish Medicines Agency eases the requirement for Danish labelling and instructions for use for medical face masks.
The Danish Medicines Agency is temporarily permitting medical face masks (surgical/medical face masks) with Swedish, Norwegian and English labelling and instructions for use.

In light of the increasing rate of infection in Denmark and the health authorities resulting tightening of the recommendation on using face masks, the Danish Medicines Agency is now changing its practice to ensure the supply of medical face masks in Denmark.

The Danish executive order on medical devices, section 3(4), stipulates that the information listed in Schedule I, paragraph 13, must be in Danish when medical devices reach the end user, regardless of whether it is for professional or other use. However, in exceptional circumstances, the Danish Medicines Agency may permit that these details are not available in Danish.

The Danish Medicines Agency is temporarily allowing medical face masks which depending on their filtration capabilities are called type I, type II or type IIR pursuant to EN 14683:2019 to have labelling and instructions for use in Swedish, Norwegian or English.

This measure has immediate effect, which means that medical face masks with Danish, Swedish, Norwegian and English labelling and instructions for use ca be marketed, distributed and used in Denmark from 18 August 2020. This may take place without the prior authorisation of the Danish Medicines Agency.

This is a temporary measure effective until 1 December 2020 until further notice.

Medical face masks must still comply with any other requirements for medical devices, including that medical face masks must be CE marked to make it clear to the user that they meet the legal requirements for safety and performance.  

Note that this change affects only the language requirement for medical face masks. Any other types of masks, such as personal protective equipment, could be subject to other rules and language requirements.

The Danish Health Authority’s recommendations on using face masks are available from its website, where you will also find information and helpful advice on face masks.

Correct labelling of a Class I medical device

Normally, correct labelling of a Class I medical device must at least include:

  • a CE mark with or without the four-digit identification number, depending on whether it is a sterile or non-sterile face mask,
  • a lot/batch number,
  • production and expiry dates,
  • a description of the device and its intended use,
  • if necessary, instructions for use (IFU), either directly on the inner cardboard or in the form of a package leaflet,
  • identification of the manufacturer,
  • an indication of an authorised representative if the manufacturer is based outside the EU,
  • labelling in Danish.

To enable identification of the product and ensure that it has been legally imported to the Danish market, the product must be supplied with the above details. Selling face masks without the original packaging is therefore not allowed.

Respiratory protection/respirator masks such as FFP2 and FFP3 masks are classified as personal protective equipment and fall under the sphere of the Danish Safety Technology Authority. You can find more information about these products on the website of the Danish Safety Technology Authority .