MKEn’ X

Guidance on regulatory requirements for face masks manufacturers in the EU

You are planning to launch your production line of face masks and you are seeking information about regulations, marking, or any other requirements to operate your activity in the EU. Here is MKEnX's guide from our advisers to provide you with the relevant information.

The EU regulations about face masks are divided into medical (medical masks) and industrial (respirators) use.

Medical Masks

Medical face masks protect the wearer's face from contact with body fluids, bacteria and various particles. 

Regulations

Medical face masks are considered as medical devices and are regulated by the EU laws of medical device regulations. Such regulations define the legal obligations in order to ensure that medical face masks will provide the minimum level of protection against intended risks. Specific requirements by classification are cited in the referenced performance standard.
Marking

Classified as either a Class 1 or Class 2 medical device, medical masks designed for the EU market must meet the labelling requirements of the corresponding standards.

Respirators

Designed to provide the wearer with respiratory protection against inhalation of a hazardous atmosphere, respirators are designed for the efficient filtration of airborne particles.

Regulations

Respirator regulations are the jurisdiction of the EU safety agency, and define the legal obligations to ensure that respirators provide the minimum level of protection against intended risks. Specific requirements by classification will be contained within regulation or cited in referenced performance standard.

Marking

Particle filtering half masks complying with the European standard must display a range of information on the product itself and on its packaging per those described in EN149 clause 9 and 10.

Source: SGS Protective Face Mask Testing & Certification