Information for companies on face masks
Face masks classified as medical devices (generally known as surgical masks or disposable face masks) must be CE marked like any other medical device, and it must usually be supplied with instructions for use in Danish. However, given the current situation, we are temporarily allowing medical face masks with labelling and instructions for use in Swedish, Norwegian and English.
Face masks classified as medical devices are often white and blue three-layer face masks with tie-on bands or elastic ear loops, intended to be used only once. Depending on their filtration capabilities, they are called type I, type II or type IIR. The CE mark must appear from the product’s packaging.
The links below offer more information on sterile and non-sterile face masks, requirements for labelling, language and instructions for use as well as guidelines on the supply of free face masks.
Questions and answers about face masks
How do I know if the masks I sell are medical devices?
If the declared purpose of the mask is medical, then it is a medical device and must meet the applicable medical device legislation and therefore be CE marked.
Is it legal to sell face masks (coverings) without a CE mark?
Yes. It is in fact legal to sell face coverings that are not CE marked, and some businesses do. But it is illegal to call them something that suggests they are medical devices or protective equipment or to market them with a medical purpose.
Nothing on the labelling must indicate that it has a medical purpose. You can read more about this on the website of the Danish Safety Technology Authority.
What requirements must medical devices meet?
You can find the requirements for medical devices on our website.
Where can I find the requirements for labelling, language and instructions for use?
You can find the requirements for labelling, language and instructions for use on our website (in Danish only).
My face masks were seized by customs and handed over to the Danish Medicines Agency. What happens now?
Face masks are sometimes seized by the Danish Customs Agency, after which the Danish Medicines Agency considers if they can be released.
Please be aware that the Danish Medicines Agency’s review of such cases could generally take up to 14 days from the day the case is handed over by the Danish Customs Agency.
Right now, we are contacted by many companies and we urge companies only to contact us if they have not heard from us within the review time of 14 days.
I would like to import medical face masks. What can I do as importer to avoid my face masks being seized by customs?
It is of major importance for importers of medical devices to be extremely familiar with the legislation before ordering any products to Denmark.
We see that both newer and more experienced importers are taken by surprise by the requirements for labelling and documentation when products are seized by customs, which is a highly frustrating situation for many involved.
On our website www.medicaldevices.dk you can read about anything from requirements to registration and documentation. Make sure you have taken care of everything before you import the product. Keep in mind that the products will pass smoothly through the system when fulfilling the legislation.