Relaxation: Information on face masks permitted to be in Swedish, Norwegian or English besides Danish
The Danish Medicines Agency temporarily eases the requirement that the instructions for use and labelling of surgical face masks must be in Danish. This permits the sale of face masks with labelling and instructions for use in Swedish, Norwegian or English until 1 December.
To make it easier for companies to ensure supplies to the general public of CE marked face masks, the Danish Medicines Agency has eased the requirement which stipulates that the labelling and instructions for use of CE marked face masks must be in Danish.
The temporary rules mean that the labelling and instructions for use, besides Danish, are allowed in Swedish, Norwegian or English, provided the face masks otherwise conform to the general requirements for medical devices. These requirements include:
- Medical face masks must be CE marked to clearly indicate that they meet the legal requirements for safety and performance.
- The name of the manufacturer must be clearly indicated on the package, i.e. who made the device and is responsible for ensuring that it meets the applicable requirements. The labelling must also include information that identifies the exact product, including a so-called reference number and a lot number.
- Finally, if the manufacturer of the face mask is located outside the EU, then the product’s label must bear information about who represents the manufacturer in the EU.
The temporary language requirement changes apply only to surgical masks – other types of face masks such as personal protective equipment could be regulated by other rules and language requirements.
Read more about the face mask requirements on our theme page: Advice to consumers on buying face masks (in Danish)
Read more recommendations about the use of face masks on the website of the Danish Health Authority: Face mask requirement if going by puclic transport and special recommendations for people at higher risk (in Danish).