As the world continues to be hit hard by the COVID-19 pandemic, the European Union is facing shortages of necessary personal protective equipment (PPE) and medical devices, such as face masks. Given the surge in demand for these products, legislative measures have been implemented at both the national and European levels to guarantee their availability, while at the same time, ensure that they offer an adequate level of protection for the health and safety of the principal users: healthcare professionals and patients.
Calls upon industry et individuals to work together to produce masks are flourishing on the net, as can be evidenced by the number of make-your-own-mask tutorials available on YouTube. These actions are commendable; however, we must all keep in mind that a mask has a protective role and must therefore meet performance requirements associated with the level of protection required.
Amid this public health emergency, we present an overview of the regulatory and normative framework surrounding the production of face masks, in order to clarify certain ambiguities linked to false information currently circulating on the subject. We hope that this article can provide valuable information for manufacturers wanting to quickly and effectively produce face masks, and other PPE or medical devices, in the fight against this pandemic.
Some ground rules
All products placed on the market in the European Union must comply with the applicable regulatory requirements, which are based upon intended use and manufacturers claims, even during a state of emergency.
So before launching the production of face masks, these essential steps must be followed:
- Determine the regulatory status of the mask to identify the applicable regulation(s).
- Identify and analyze the applicable regulatory requirements
- Identify the safety and performance tests to be carried out
- Select the conformity assessment procedure to be applied
Are protective face masks considered to be PPE or medical devices?
Depending on its intended use, a mask will meet either the definition of a medical device or the definition of personal protective equipment.
“Surgical” or “medical” face masks: medical devices
Intended use: Surgical or medical face masks are intended to reduce the emission of infective agents from the nose and mouth of the person who is wearing the mark (when coughing, sneezing, etc) à Protect others by reducing the spread of infection from the wearer of the mask.
Note: An added side-benefit of these masks is a limited protection of the wearer from exposure to viruses and/or bacteria.
Medical face masks must comply with the safety and performance requirements of the Directive 93/42/EEC or the Medical Device Regulation (EU) 2017/745. They are Class I products, which bear the CE marking; however, they do not require the intervention of a Notified Body (NB). It is therefore the responsibility of the manufacturer to carry out a conformity assessment before placing a mask on the market.
These masks must be designed, manufactured, and tested according to the methods specified in EN 14683 + AC (2019) Medical face masks, Requirements and test methods to demonstrate compliance with performance requirements in terms of bacterial filtration efficiency (BFE), breathability, splash resistance, and microbial cleanliness.
This standard classifies masks into three types based on their effectiveness:
- Type I filters a minimum of 95% of bacteria
- Type II filters a minimum of 98% of bacteria
- Type II “R” filters a minimum of 98% of bacteria and is fluid resistant.
Keep in mind: In the context of an epidemic or pandemic, masks for medical use are reserved for asymptomatic carriers or a patient with clinical symptoms.
Masks for use as respiratory protective equipment: PPE
Intended use: Respiratory protective masks are intended to protect the wearer from inhalation of infectious agents and aerosols.
Respiratory protective masks must comply with the health and safety requirements of Regulation (EU) No. 2016/425 on personal protective equipment. They are Class III products, which bear the CE marking and require the intervention of a NB to carry out a conformity assessment before being placed on the market.
These masks must be designed, manufactured and tested according to the methods specified in EN 149 (2001) + A1 (2009) Respiratory protective devices – Filtering half masks to protect against particles. Requirements, testing, marking to demonstrate compliance with performance requirements in terms of total inward leakage, penetration of the filter material, compatibility with skin, flammability, CO2 content of the inhalation air, breathing resistance, etc.
The standard specifies three classes of protective masks based on filtration efficiency and maximum inward leakage: FFP1, FFP2, and FFP3.
The shape of respiratory protective masks must be adapted to the wearer’s face to ensure a sufficient seal. They may also have one or more exhalation valves.
Keep in mind: FFP2 class masks are used by healthcare professionals for the management of patients suspected of presenting symptoms of respiratory infection.
Covid-19 Public health emergency: the measures that have thus been implanted to protect the health and safety of our citizens
The Décret n°2020-190 was published on March 4 in the JORF concerning the requisitions necessary within the framework of the fight against the COVID-19 virus.
To ensure priority access to health professionals and patients, this decree thereby orders the requisition of the following face masks until May 31, 2020:
- Stocks of FFP2 respiratory protective masks held by any legal persons, corporate or private;
- Stocks of anti-projection masks held by companies that manufacture or distribute them.
- All FF2 respiratory protective masks and anti-projection masks produced between the publication of this decree and May 31, 2020.
The COMMISSION RECOMMENDATION (EU) 2020/403 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat was published on March 13, 2020.
The purpose is to implement measures to ensure the continued availability of PPE and medical devices, such as face masks, to those who need them most, while ensuring an adequate level of protection of the health and safety of users.
Competent Authorities may thereby allow the placing on the market of PPE or medical devices which do not bear the CE marking, for a specified period of time, if they find that these products comply with the applicable regulatory requirements regarding health, safety and performance.
The Member States must, however, ensure that these non-CE-marked products are made available exclusively to healthcare professionals and only for the duration of the current health crisis.
In addition, NB are obligated to quickly perform conformity assessment activities on any new applications submitted under the PPE Regulation for respiratory protective masks necessary to provide protection against the COVID-19 virus.
In the context of the current COVID-19 pandemic, medical face masks and FFP2 type masks are in exceptionally high demand. Although the European Union and each Member State have implemented specific measures to facilitate the placing on the market of these types of masks, it is nevertheless essential to demonstrate compliance with either the PPE or the medical device regulations, depending on the type of mask, in order to guarantee product performance and the health and safety of our citizens.
Is your company is setting up to manufacture these much-needed products, such as face masks, surgical gloves, or in vitro diagnostic tests, as part of the global effort to provide critical medical devices used in the treatment or the prevention of spread of the COVID-19 virus ?
If the answer is yes, our team is here to help you, even from the comfort of our home offices 🙂.
Written by:
Kayla Viegas, Consultant
Camille Pelé, Director – Knowledge Management and Consultant
References:
- Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
- Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
- EN 14683 + AC (2019) Medical face masks, Requirements and test methods
- Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment
- EN 149 (2001) + A1 (2009) Respiratory protective devices – Filtering half masks to protect against particles. Requirements, testing, marking
- Décret n°2020-190 du 3 mars 2020 relatif aux réquisitions nécessaires dans le cadre de la lutte contre le virus COVID-19
- COMMISSION RECOMMENDATION (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat