This blogpost aims to provide useful information for parties involved in the development of face masks in the fight against the COVID-19 pandemic. It lists the impact of the recommendations from the European Commission  on the development and distribution of face masks.
In general, two types of face masks are used to protect healthcare professionals and patients against the virus: 1) surgical masks and 2) respiratory face masks. The first type of face mask is classified as a medical device, while the second is classified as personal protective equipment (PPE). The masks are regulated by different legislation (figure 1). The WHO (World Health Organization) recommends hospitals use surgical masks when providing direct care to COVID-19 patients. In case this direct care involves aerosol generating procedures, such as tracheal intubation, the respiratory face mask has to be worn. 
Surgical masks are classified as medical devices and therefore have to comply with Directive 93/42/EEC or with Medical Device Regulation 2017/745 (which comes into effect in May 2021).  According to the Medical Device Directive, surgical masks are a class I medical device. For class I devices, the manufacturer must affix a CE mark on the device and draw up an EC declaration of conformity before introducing the device on the market. Part of the declaration of conformity is documenting that the device meets the essential safety and performance requirements in the device’s technical file. The directive also states that compliance of the device with an EU-harmonized standard is enough for the member states to presume compliance with the essential requirements and to affix the CE mark.
For surgical masks, the EU-harmonized standard is EN 14683, which can be used to develop and test surgical face masks. This standard classifies masks by several types, the Dutch government recommends the use of type IIR surgical masks for the direct care of COVID-19 patients , while the Belgium government does not specify the type of surgical mask in their informative guideline. They did, however, publish an alternative test protocol (see last section of this blogpost).
Involvement of a notified body in the conformity assessment is only needed for surgical masks that are claimed to be sterile, which is not the case for the masks used to care for COVID-19 patients.
Respiratory Face Masks
Design, manufacturing and introduction on the market requirements for PPE are laid down in Regulation 2016/425, which classifies these respiratory face masks as a category III high-risk PPE. The regulation tells us that the PPE has to conform with the regulation’s health and safety requirements, and that a CE marking needs to be affixed to the PPE in order to be distributed in the EU. Like the directive on medical devices, this regulation also states that compliance of the PPE with an EU-harmonized standard is enough to presume conformance to the health and safety requirements.
For respiratory face masks, the EU-harmonized standard applicable are EN 149:2001+A1 and EN 13274-7 (for testing of the filter penetration). These standards can be used for developing and testing the face masks and distinguishes three classes of face masks. The WHO recommends the use of at least the filtering efficiency of FFP2 class face masks for aerosol generating procedures. 
The conformity with the requirements has to be assessed by a notified body in order to obtain the CE marking and allow for introduction on the market. The conformity assessment starts with an EU type-examination during which the notified body examines the technical design of the PPE type, including a check of the correct use of the harmonized standard. In addition, the notified body regularly checks samples of the PPE to verify the homogeneity of the production process or the notified body reviews the manufacturer’s quality system by conducting an on-site audit. In case of a successful conformity assessment, the CE marking, including the notified body’s identification number, can be affixed on the PPE, the manufacturer can draw up the EU Declaration of Conformity and introduce the PPE on the market.
Recommendation of the European Commission within the context of COVID-19
In the context of the extra demand for PPE and medical devices due to the COVID-19 outbreak, the European Commission has published a recommendation that impacts the conformity assessment procedures we just described. 
They emphasize that the use of a harmonized standard is not mandatory and manufacturers are free to choose other technical solutions to show compliance with the essential requirements. However, masks shown to comply with the harmonized standard do not have to be re-tested by a third party, thus allowing swifter introduction on the market. The Belgian Federal Agency for Medicines and Health (FAMHP) has even introduced a simplified alternative test protocol (ATP). This enables the introduction of surgical masks on the market that do not meet the harmonized standards , but only under very strict conditions.
Furthermore, the European Commission lets member states deviate from the conformity assessment procedure by allowing placement of non-CE marked PPE on the market while the conformity assessment of the notified body is still being carried out. Provided that the PPE is tested by an accredited laboratory, the availability of the non-CE PPE is for a limited time period and the non-CE PPE is only made available to healthcare workers. This should speed up the market introduction of PPE imported from outside Europe and PPE from new manufacturers.
Webinar: How to develop a medical device?
On Wednesday April 29th Comate Engineering & Design organizes a symposium on the development of medical devices and all the technical and regulatory challenges involved in this process. We are proud to announce that QbD will take care of one of the keynotes. Steven Vinkx will give an interesting presentation on the Regulatory Pathway and quality aspects for medical devices, and there will be a link with Covid-19. We hope to see you all there!
- Standards for MD and PPE from the Dutch National Standardization body NEN.(free to download after registration)
- Standards for MD and PPE from the Belgian National Standardization body NBN.(free to download after registration)
- Delivery conditions including alternative testing standards for respiratory masks issued by Belgium government.
- Delivery conditions including alternative testing standards for surgical masks issued by Belgium government.
- Information regarding alternative testing standards and coordination of distribution issued by the Dutch government.
- The FAHMP Alternative Test Protocol (ATP) for surgical masks
 eur-lex.europa.eu, 2020/403, 13 March 2020
 Rational use of personal protective equipment (PPE) for coronavirus disease (COVID-19)