Millions of face masks in Switzerland fail to conform to regulations

The inspection targeted over 34 million masks destined for healthcare institutions, including hospitals. Keystone / Jean-christophe Bott

Ten out of 29 shipments of medical face masks contained products that did not meet regulations, according to an audit conducted by the Federal Customs Administration and Swissmedic.

The 29 shipments inspected between May and July 2020 correspond to over 34 million protective masks destined for healthcare settings, such as hospitals, Swissmedic said on Tuesday. Among the shortcomings found was the absence of compliance mark CE on the packaging to indicate that the masks meet health-and-safety requirements set out by relevant European Union directives.

Swissmedic, the agency responsible for market surveillance of medical devices, subsequently launched five administrative proceedings. One of them led to masks being banned from the market for medical use.

In June Swissmedic issued a warning about potentially inferior face masks appearing in Switzerland, as sellers with no experience in the therapeutic products sector began importing and selling masks. Medical face masks, also known as surgical masks, must meet standard EN 148683 and be labelled with a CE mark. Masks that do not conform to these requirements must be labelled “not for medical use”.

The inspection was part of a global campaign to combat the trade in illegal drugs and medical devices coordinated by the World Customs Organization. Authorities from 99 countries participated in the operation, dubbed “Operation Stop”.