[ARTICLE] The Regulatory Landscape and the Conformity Assessment Pathways for Masks

March 8, 2021
|In Market Access, Product Development
|By Marieke Moliner

Masks have become the mainstay of public health measures adopted during the SARS-CoV-2 pandemic. This article outlines the regulatory landscape and illustrates the nuances that dictate the correct market entry and regulatory strategy for Legal Manufacturers of the various types of masks.
 
A distinction can be made between three types of masks:

  • Community face coverings,

    •  

  • Surgical/medical masks, and

    •  

  • Filtering face pieces/respirators

 

Community face coverings

 

Community face coverings are sewn from commercially available fabrics and worn in everyday life. In contrast to medical face masks or particle filtering half masks, the EU regulatory framework has not established specific legal provisions for community face coverings. The General Product Safety Directive (GPSD) 2001/95/EC would therefore apply to these masks.
 
Thus, these are typically not tested in accordance with any relevant legal and normative requirements, and without prejudice to potential specific provisions of EU Member State national legislations regulating these types of face masks, they can therefore be brought to market without any regulatory procedures. In light of the SARS-CoV-2 pandemic, however, these have become a fundamental element of national strategies for containing the spread of the virus, and the European Commission has identified the urgent need for a harmonised and consistent degree of safety in community face coverings.
 
To respond to this with urgency, CEN has published a workshop agreement on “Community face coverings – Guide to minimum requirements, methods of testing and use”, in which considerations relating to design, performance, test methods, packaging, marking and, information for use are noted.
 
Community face coverings are however not subject to any mandatory conformity assessment by notified bodies or laboratories.
 
Their design in accordance with accepted best practices and production quality control shall remain the producer’s responsibility [1].
 
Community face coverings that are placed on the market and which meet the requirements laid down in the workshop agreement can be designated as follows: Community face coverings CWA17553:2020 or National specification designation followed by CWA 17553:2020.
 

Surgical Masks

 

Surgical masks, also called ‘procedural’ or ‘medical’ masks protect the patient from transmission of infective agents from the wearer and, additionally, in certain circumstances protect the wearer against splashes of potentially contaminated liquids.
 
These may also be intended to be worn by patients and other persons to reduce the risk of spread of infections, particularly in epidemic or pandemic situations [2]. By virtue of their use “during treatment of human beings”, and “for prevention of disease”, these qualify as Medical Devices.
 
Before placing these on the European market, Legal Manufacturers are therefore required to ensure compliance with European Medical Device Directive 93/42/EEC as amended by Directive 2007/47/EC (only possible until 26 May 2021) or European Medical Device Regulation (EU) 2017/745.
 
When worn correctly, such masks cover the nose with the metal band contouring the bridge of the nose, the mask is drawn under the chin and secured in place with ear loops or by tying the tapes firmly around the back of the head. Even though these masks offer high degree of bacterial filtration efficiency, they do not form a tight seal around the nose and the mouth and are understood to function as barriers that offer only limited protection.
 

Filtering face pieces

 

Filtering face pieces (FFP), on the other hand, form a tight seal around the nose and mouth [3] and protect the user from being exposed to noxious particles, gases and microorganisms including bacteria, viruses and fungi. By virtue of these masks being “worn for protection against one or more risks”, these qualify as Personal Protective Equipment.
 
Before placing these on the European market, Legal Manufacturers are therefore required to ensure compliance with European Personal Protective Equipment Regulation (EU) 2016/425.
 
The intended use and the specific claims advanced by the Legal Manufacturer determine the product category to which a mask will belong, and the subsequent conformity assessment procedures.

    1/ As medical devices, single use, non-sterile masks usually fall in the lowest risk classification (Class I). For such products, after fulfilling the obligations specified in Art. 10 of (EU) 2017/745:

    • the Legal Manufacturer will register the product,
    • issue a Declaration of Conformity, and
    • affix the CE mark to the product before placing it on the market.

     
    2/ As personal protective equipment, masks intended to protect the wearer from harmful/noxious substances and particles fall in the highest risk categorisation (Category III). For such products, after fulfilling the obligations specified in Art. 8 of (EU) 2016/425, the Legal Manufacturer shall submit an application for conformity assessment to a Notified Body that will :

    • perform an EU-type examination and a review of the Technical Documentation (Module B),
    • followed by either:
      • a review of production quality assurance (Module D), or
      • internal production control plus supervised product checks at random intervals (Module C2).
    • After successful completion of the conformity assessment, the Legal Manufacturer shall affix the CE mark to the product before placing it on the market.

 
Table 1 summarises the major differences between these masks and the applicable regulatory requirements.
 
the major differences between these masks and the applicable regulatory requirements
 

How Medidee can help

 

At Medidee, our expertise extends to designing market entry strategies, and review/preparation of Technical Documentation and Quality Management Systems needed by Legal Manufacturers of Surgical/Medical Masks and FFP/Personal Protective Equipment. Contact us now!
 

This article was written by Dr Mohit Kumar.

 

References

[1] “Community face coverings – Guide to minimum requirements, methods of testing and use,” CEN-CENELEC Management Centre, Brussels, CWA 17553:2020, 2020.

[2] “Medical face masks – Requirements and test methods,” CEN-CENELEC Management Centre, Brussels, EN 14683:2019+AC:2019, 2019.

[3] “Respiratory protective devices – Filtering half masks to protect against particles – Requirements, testing, marking,” CEN Management Centre, Brussels, EN 149:2001+A1:2009, 2009.