Advice to consumers on buying face masks

Updated 16 February 2021

If you go and buy a face mask which is classified as a medical device, it must be CE marked just like any other medical device, and instructions for use in Danish must normally be supplied with it. However, given the current situation, we are allowing medical face masks with labelling and instructions for use in Swedish, Norwegian and English for a temporary period of time.

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.

Technical requirements

Depending on their filtration capabilities, they are called type I, type II or type IIR.

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 moreover contain a lot or batch number. Also, the labelling must include information that identifies the exact product, possibly a so-called reference 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.

 
 

Questions and answers about face masks

The Danish Health Authority provides guidelines on the use of face masks. You can find the current Danish guidelines on face masks on the  website of the Danish Health Authority. There is also a section in English.

 

Mask is a broad term for both protective equipment and face masks of medical/surgical quality.

You can think of protective equipment as something you wear to protect yourself, whereas a face mask of medical/surgical quality is something you wear to avoid infecting others.

Protective equipment could be of the type FFP1, FFP2 and FFP3, whereas face masks of medical/surgical quality are of the type I, II and IIR. The type refers, among other things, to how much filtering the product provides, and this applies to protective equipment as well as medical devices.

Protective equipment falls under the legislation of the Danish Safety Technology Authority, while face masks of medical/surgical quality fall under the legislation of the Danish Medicines Agency.

There should be a clear CE mark on the package.

No. Medical devices must be sold in the original packaging from the manufacturer. The product needs to be in its original packaging because the face masks are supplied with information on how to use the device correctly, and the packaging, labelling and instructions for use are part of the device.

 

No, not if you only need it to go out in public. Choosing a sterile product could be relevant for people like surgeons who need to work in a sterile environment, but it is not necessary for the general public.

 

No. There is no requirement for face masks to be sold in certain bags or boxes.

 

The manufacturer must be able to document that the face masks meet the legislation. The product cannot be CE marked and sold on the Danish market before it meets the applicable legislation.

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