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 face masks protect the wearer's face from contact with body fluids, bacteria and various particles.
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.
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.
Designed to provide the wearer with respiratory protection against inhalation of a hazardous atmosphere, respirators are designed for the efficient filtration of airborne particles.
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.
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.
- EN 14683:2019+AC:2019 Medical face masks - Requirements and test methods
- EN 149:2001+A1:2009 Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking
- Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC
- Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
- CE marking: medical suppliers and protective equipment
- European Committee for Standardization for CEN Members
COVID-19 Regulatory Updates
- Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat
- Guidance on regulatory requirements for medical face masks: Options for supporting production and/or placing on the market of medical face masks in the context of COVID-19 pandemic
- Coronavirus: European standards for medical supplies made freely available to facilitate increase of production