Coronavirus: updated guidelines for verifying the compliance and suitability of surgical face masks

Due to the COVID-19 crisis, production of surgical masks has significantly increased. Therefore, the Belgian Competent Authority FAMHP has issued guidelines for checking the compliance and suitability of surgical face masks. Following the amendment to the ministerial decree of 23 March 2020 laying down specific measures within the framework of the SARS-CoV-2 pandemic, the retail trade in surgical face masks is no longer reserved for pharmacies, instead, it has also been opened to the usual distribution channels.

Firstly, we should differentiate between the diverse types of masks that can be used both as a preventive and a protective measure against the spread of COVID-19: surgical masks and respiratory protection masks (dust masks).

1. Surgical or Medical Masks: These are Class I medical devices. They can be used both to protect the patient from particles and any pathogens coming from the medical personnel, and to reduce the risk of spreading infections in a pandemic or epidemic context. For this type of masks, a further distinction must also be reported:

  • Sterile with CE marking: the manufacturer (or his authorized representative) has to draw up a Declaration of Conformity. Moreover, a CE Certificate issued by a Notified Body is required. This means that the CE Marking, which has to be affixed, must also be accompanied by a four-digit code identifying the intervening Notified Body under Directive 93/42 / EEC or Regulation 2017/745;
  • Non-Sterile with CE marking: A Declaration of Conformity should be provided by the manufacturer. At the same time, the CE marking must be affixed in order to place this type of masks on the EU Market, however a CE Certificate is not required;
  • Surgical Masks without CE marking: Exceptionally, due to the COVID-19 crisis, both sale and use of surgical masks which do not bear the required CE marking can be accepted. In this regard, the FAMHP accepts either certain tests performed by an accredited laboratory, or certificates issued by a third entity in accordance with EN 14683/ASTM F2100/YY 0469:2011 and YY/T: 0969-2013. In both cases, used standard should be indicated. Normally, only accredited EU entities can test against the EU standards. However, if the organization  is present on the lists of institutes accredited by the Chinese government , the corresponding tests could be accepted. Conversely, if they cannot be provided, devices are not compliant due to lack of related documentation.

2. Respiratory protection masks (dust masks): These are classified as personal protective equipment (PPE). For these masks, all conditions can be consulted on the website of the FPS Economy.

For both surgical and respiratory protection masks, it has been highlighted the risk of circulation of fake certificates to be verified on the European Safety Federation website.

Fabrizio Gallo
Regulatory Affairs Department

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