At the beginning of the COVID-19 pandemic, there was a global shortage of surgical face masks marketed under the European legislation on medical devices. The FAMHP therefore took two exceptional measures to help companies, authorities and health institutions obtain masks that meet the minimum quality requirements for use during the pandemic.
These measures allow for derogations from the CE marking and conformity assessment described in the Commission Recommendation 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat.
Exceptional measures for surgical face masks
- Alternative standards. Masks marketed as medical devices in Europe must comply with the regulations. Their quality shall be tested according to European standard EN 14683. For the duration of the COVID-19 pandemic, the conditions of supply and release have temporarily been modified, allowing surgical face masks to be considered as medical devices if their compliance with alternative international standards similar to European standard EN 14683 could be demonstrated.
- Alternative Test Protocol (ATP). In addition, the use of an Alternative Test Protocol (ATP) is permitted in order to determine the quality and adequacy of masks for which compliance with European rules on medical devices or temporarily accepted international standards could not be demonstrated.
These measures made it possible to provide healthcare professionals and the population with surgical masks of sufficient quality, through regular distribution channels, that could not be sold as medical devices under normal circumstances. Thereby shortages of these masks were avoided.
In recent months, surgical face masks have become gradually available. As a result, there is no longer a shortage of masks marketed in full compliance with European rules on medical devices.
The FAMHP has thus decided to put an end to the temporary derogations for the CE marking and conformity assessment of masks and therefore to the two exceptional measures (alternative standards, ATP) 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 derogations (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.