According to the World Health Organization, the COVID-19 virus is transmitted via small airborne droplets which are transmitted by infected individuals through coughing, sneezing or talking. The use of face masks may reduce the spread of the novel coronavirus by decreasing the amount of infected droplets being emitted into spaces and onto surfaces.
Face masks sold in the European Union fall under the scope of the European Commission product directives, meaning that they must bear the CE marking. The CE mark indicates that a product meets the European legal requirements for safety, health and the environment.
Before affixing the CE marking, the manufacturer must ensure that their product complies with all relevant standards, have performed a risk assessment, compiled a technical file and drawn up a Declaration of Conformity. The CE marking process differs for every product and depends on which standards must be taken into account.
The EU health and safety standards that a mask must comply with depend on what type of mask it is. Face masks fall into two main categories: surgical masks and respirators.
Surgical masks, also known as medical face masks or procedure masks, are considered medical devices and fall under the scope of the Medical Device Directive (MDD).* Under the MDD, the standard EN 14683 specifies the construction, design, performance requirements and test methods for medical face masks. These masks are classified into 3 levels based on bacterial filtration efficiency, breathing resistance and splash resistance:
- Type R
Surgical masks can be self-certified, meaning that the manufacturer can perform the conformity assessment themselves. If the mask meets the requirements of the Medical Device Regulation then the manufacturer can draft the Declaration of Conformity and affix the CE Marking.
Please note that sterile mouth masks must be tested by a Notified Body (self-certification does not apply in this case). The 4 digit code of the Notified Body must be mentioned on the Declaration of Conformity and next to the CE mark logo.
*The Medical Device Regulation (EU 2017/745), which will replace the Medical Device Directive, was set to come into force on the 26th of May. However, the MDR implementation date is postponed by one year so that the health sector can prioritise the fight against the Coronavirus pandemic. Read the official amendment here.
Respirators are tight-fitting masks designed to protect the caregiver. They are considered Personal Protective Equipment (PPE), fall under the scope of Regulation (EU) 2016/425, and must also be tested by a Notified Body before the CE Mark may be affixed. The regulation outlines 3 classes of respirators, depending on how much protection from outside substances is provided:
- FFP1 (80% filter, max. 22% leakage)
- FFP2 (94% filter, max. 8% leakage)
- FFP3 (99% filter, max. 5% leakage)
Respirators differ from surgical masks in that they protect the user from exposure to airborne particles, whereas surgical masks do not effectively filter such small particles. Respirators can be used by healthcare professionals to protect themselves against the coronavirus when exposed to infected individuals or environments. Surgical masks, on the other hand, act as a barrier to prevent splashes, droplets and spit, and can be used to prevent an individual from contaminating their environment.
CE marking face masks during COVID-19
The EU is currently facing supply bottlenecks for both respirators and surgical masks. In order to facilitate the supply of face masks, the European Commission has released temporary guidelines under which critical medical devices and PPE can be sold without CE marking (read the conditions here).
Normally, standards must be purchased and used in line with intellectual property right rules, but the European Commission has temporarily made all relevant standards freely and publicly available to ensure that all masks which are manufactured meet EU directives for health and safety. You can download the standards from the websites of CEN national members.
The European Commission has also provided additional recommendations for actors in the supply chain to facilitate the production and distribution of face masks:
- Notified bodies should prioritise the conformity assessments for new requests of PPE and critical medical devices
- Market surveillance authorities may authorise products for the EU market without finalised conformity assessment procedures if the equipment adequately meets EU standards for health and safety
- Manufacturers are provided with additional guidance to produce compliant protective equipment
- Importers must check whether the appropriate conformity assessments have been properly carried out, whether the CE mark logo is properly affixed, and whether the technical file is complete and includes a DoC
Verifying face mask compliance
The higher demands for PPE and critical medical devices have led to an increase in fake documents presented as proof of compliance. To ensure that a mask has been properly CE marked, check the Declaration of Conformity. The DoC is an official certificate drawn up by the manufacturer or their authorised representative to ensure that a product is in compliance with all relevant EU safety requirements. It should include the following information:
- Name and full address of the manufacturer
- Product identification (name, function, model, type, serial number, commercial name)
- Applied directives and harmonised standards
- Notified Body information and identification number
- Authorised representative information (if relevant)
- Name and signature of the party drafting the declaration on behalf of manufacturer/AR
- Date of issue
To verify the DoC, check that it mentions a competent Notified Body based in the EU (including EFTA and Turkey). If you still have doubts, you can contact the responsible party directly through the information provided on the DoC. You can also contact us to verify the validity of the DoC. We will check whether it meets and mentions all necessary standards and testing procedures to ensure that applicable requirements are met.
While ensuring face mask compliance is not a simple task, it is crucial that masks being manufactured, sold and used within the European Union meet relevant standards for health and safety. As we’ve outlined in this article, distinguishing between surgical masks and respirators will determine which EU directives need to be taken into account. If you have questions about medical devices or PPE compliance, contact us. Our experts are happy to guide you through the CE marking process, check your technical documents or answer any compliance-related questions.