The Medical Devices Ordinance (MedDO) prohibits the dispensing to the general public of in vitro diagnostic medical devices for the diagnosis of transmissible human diseases. Exemptions for Sars-CoV-2 self-tests were specified in COVID-19 Ordinance 3 and have been in effect since 7 April 2021.
Swissmedic takes action against dispensing of non-compliant rapid tests by Swiss online shops
Swissmedic received a total of 51 reports concerning Sars-CoV-2 rapid tests between February and June 2021. This corresponds to around one-quarter of the total annual reports received concerning medical devices prior to the pandemic. Reports were largely made by market players (37%), private individuals (20%), federal authorities excluding Swissmedic (18%) and cantonal authorities (12%).
Swissmedic examined reports of suspicious activity concerning dispensing of Sars-CoV-2 rapid tests, reviewed claims and product information in online shops and carried out test purchases from suppliers in Switzerland. In 15 cases (29%), administrative proceedings were initiated and dispensing of the tests prohibited by an official decision. Two market players voluntarily ceased dispensing immediately after intervention by Swissmedic. Several market players supplemented the sales process in their online shops with technical and administrative measures to rule out the possibility of Sars-CoV-2 rapid tests for professionals being dispensed to the general public. Swissmedic carried out follow-up checks in these cases. In a few serious cases, criminal administrative proceedings were initiated by Swissmedic’s Penal Division in parallel to administrative proceedings.