Date: 23/12/2020 - source FAGG
During the first months of the COVID-19 pandemic, the FAMHP took a number of exceptional measures to guarantee sufficient availability of surgical mask that meet the minimum quality requirements for use as medical devices. These exceptional measures will be lifted on 1 February 2021.
During the first months of the COVID-19 epidemic, the supply of various medical devices for health care, including surgical face masks, was difficult. The FAMHP took exceptional measures to guarantee sufficient availability of masks that meet the minimum quality requirements for use as medical devices during this COVID-19 pandemic. On the basis of these measures, surgical masks that would normally be considered non-conforming could be temporarily made available on the market as medical devices.
The exceptional measures applied to surgical masks that were made available on the market as medical devices and for which it could be demonstrated that they complied with alternative international standards that could be considered comparable to the EN 14683 standard, or for which a minimum quality could be demonstrated on the basis of the Alternative Test Protocol (ATP).
As the supply of EU-compliant masks to the market is now recovering, the FAMHP no longer considers these exemption measures necessary and has decided to discontinue them on 1 February 2021. From that date, surgical oral masks marketed as medical devices will only be released or marketed again if they comply with European standards.
The masks released before 1 February 2021 on the basis of these temporary exceptional measures (alternative standards, ATP) may be made available on the market until 1 August 2022 at the latest or until the expiry date indicated by the manufacturer.