Coronavirus: swabs: compliance verification
February 11, 2021
Certain tests for COVID-19 use nasal swabs. Swabs are medical devices that must have a CE mark and meet certain requirements. The FAMHP recommends verifying the conformity of swabs.
Several tests for the detection of COVID-19, in particular PCR and antigen tests, are carried out using a swab to take samples.
A swab is a class I medical device, in accordance with the provisions of Directive 93/42/EEC of 14 June 1993 and Regulation 2017/745 of 5 April 2017 on medical devices. It must therefore have a CE marking and comply with certain essential requirements.