A guide for manufacturers, importers, and retailers of medical face masks according to the european standard EN 14683.

Medical face masks, also referred to as surgical masks, are classified as medical devices and must be in compliance with  the European standard EN 14683. Medical face masks are often white and blue triple-layer masks with elastic earloops or tie strings and are intended for single use.

Depending on the filtering ability, they are categorised as type I, type II, or type IIR. Mostly, it is Class I medical face masks that are used to prevent spreading of Corona virus.

In Denmark, the Danish Medicines Agency (Lægemiddelstyrelsen) regulates the legislation for medical devices.

Read more about the legislation and guidelines on medical devices

Is CE marking a requirement for medical face masks?

Yes. According to the Executive Order on Medical Devices, it is required that medical face masks are CE marked when they are advertised and sold within the European market and thus also in Denmark.

The CE marking is the manufacturer’s guarantee  that the mask complies with current EU legislation.

Read more about the requirements for medical face masks in Council directive 93/42/EEC

Who is responsible for obtaining the CE marking of medical face masks?

For medical devices, the manufacturer is responsible for ensuring that the product meets the requirements and thereby can be CE marked. In the case of Class I medical devices , the manufacturer is responsible for the process of CE marking.

As a retailer of masks, you are responsible for ensuring that the product you sell in Denmark is correctly marked, CE marked, and that the correct documentation etc. is enclosed.

If you want to market and sell medical face masks that are not CE marked by the manufacturer, it is your responsibility that they get CE marked according to current legislation before they are put on the market. Thus, you are considered a manufacturer of the product and thereby assume the manufacturer’s responsibilities and obligations, as mentioned above.

Read more about procedures for prospective manufacturers of protective equipment.

How do I get a CE mark issued for my medical mask?

If you are a manufacturer or want to sell medical face masks on the Danish market that are not CE marked by the manufacturer, you must for Class I masks prepare and upon request provide a declaration of conformity as well as the technical documentation for the products compliance with EN 14683.

The technical documentation is prepared based on the essential requirements for safety and performance, which are stated in the executive orders. Also, the technical documentation must include a clinical evaluation and a risk analysis.

The medical device can be CE marked once the technical documentation is available and the manufacturer has signed the EC declaration of conformity.

Read more about the requirements for the technical documentation and declaration of conformity.

Am I required to have my medical face masks tested? 

Since you as a retailer are responsible for ensuring that your products live up to the quality requirements in the standard, you are also responsible for ensuring that the enclosed documentation is correct. If you are in doubt as to whether the documentation you have received from the manufacturer is correct, you can have it reviewed by an independent test laboratory. If the documentation does not meet the requirements, you can have the products tested so that you are sure that they comply with the requirements in the executive order and thus legislation.

If you import medical face masks from a manufacturer outside the EU that has not been tested in accordance with the requirements of the executive order, you should choose an independent, accredited test laboratory that offers tests in accordance with European standards.

Read more about testing of medical face masks.

What type  of information should appear on the packaging for masks?

The packaging must state who the manufacturer is, i.e. who is manufacturing the medical device and is responsible for ensuring that it meets current requirements. In addition, there must be information that can identify the individual product. If the medical mask is manufactured by a manufacturer outside the EU, the product must indicate the manufacturer’s representative in the EU.

Proper labelling of a Class I medical device consists as a minimum of the following:
  • Product description
  • Product identification, typically REF xxxxx
  • Production number, typically LOT xxxxx or Batch xxxxx
  • Clear indication of manufacturer, indicated as “Manufacturer”, “Manufactured by” or by the help of the manufacturer’s symbol.
  • Authorised European representative - if the manufacturer resides outside the EU, typically indicated by EC REP (NB: Not applicable when you are a manufacturer in the EU)
  • Instructions for use, unless the use is obvious, is typically indicated as instructional diagrams with text
  • Various relevant symbols such as the symbol for “Single use” or symbols for storage conditions (see ISO 15223)
Also, note that the product may only be sold in its original packaging. For a product to be identified and in order to document that the product has been legally introduced on the Danish market, the product must be supplied with the above information when sold.

Do I have to register with the Danish Medicines Agency?

Yes. If you are a manufacturer, importer, or distributor of medical masks in Denmark, you must register with the Danish Medicines Agency with information on the company’s address along with the class/type and product group of the product.

Read more about registration with the Danish Medicines Agency.

Worth knowing in relation to marketing of medical face masks

According to Section 2(2) of the Advertising Order in Executive Order no. 1155 of 22 October 2014, a distinction must be made between healthcare professionals and private individuals in advertising for medical devices. This means that if it is stated by the manufacturer that a product is intended for professional use, one may not state when advertising the product that it can be used by private individuals.

Read more about guidelines on avertising etc. of medical devices.


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