The FAMHP took a number of exceptional measures in the first months of the COVID-19 pandemic to ensure sufficient availability of surgical face masks that meet the minimum quality requirements for use as medical devices. These exceptional measures will be terminated as of 1 February 2021.
During the first months of the COVID-19 pandemic, it was difficult to supply various medical devices for healthcare, including surgical face masks. The FAMHP took exceptional measures to ensure sufficient availability of masks that meet the minimum quality requirements for use as medical devices during the COVID-19 pandemic. Based on these measures, surgical masks which would be considered non-compliant under normal circumstances could temporarily be marketed as medical devices.
The exceptional measures applied to surgical masks marketed as medical devices if their compliance with alternative international standards similar to European standard EN 14683 could be demonstrated, or if the Alternative Test Protocol (ATP) could demonstrate their sufficient quality.
As the supply of masks meeting the EU standards has become available, the FAMHP no longer considers these exceptional measures necessary and has thus decided to lift them as of 1 February 2021. From this date, surgical face masks marketed as medical devices shall only be released or marketed if they comply with European rules.
Masks released before 1 February 2021 based on the temporary exceptional measures (alternative standards, ATP) may be placed on the market until 1 August 2022 at the latest or until the expiry date specified by the manufacturer.