The French Competent Authority (ANSM) has prohibited the sale of antibody self-tests based on urine specimen, in view of its inefficacy and non-conformity with the EU requirements, i.e. because their manufacturers have not obtained a CE Certificate issued by a Notified Body.
Moreover, the disputed urines tests were made available to consumers online, even if only pharmacies are allowed to sell self-tests, except for pregnancy tests.
It should be recalled that, currently, the ANSM does not recognize any COVID antibody, nor self-tests, that could be performed by patients at home. Yet, this might change in future.
On 15 March 2021, the French Haute Authorité de Santé (HAS) has issued an Opinion that rapid antigen testing could be brought closer to the public by enlarging the sale of auto-tests in pharmacies or supermarkets, and recommends the competent Ministry to adopt an appropriate traceability system. Moreover, the HAS recalls the required performance criteria of such tests, namely the clinical sensitivity of at least 80% or higher, and clinical specificity equal or higher than 99% in symptomatic subjects. These tests could be used by both symptomatic and asymptomatic patients.
DPM Publications department
Are you a manufacturer of COVID self-tests, based outside of Europe?
Do not forget that you need to involve not only Obelis as your EAR, but also a Notified Body that will assess your device and issue a CE Certificate before you can place your self-testing device on EU markets, where this is allowed.
- ANSM. (2021). Dépistage de la COVID-19 : l’ANSM suspend la commercialisation d’un autotest urinaire. Retrieved on 19.03.2021 from https://ansm.sante.fr/actualites/depistage-de-la-covid-19-lansm-suspend-la-commercialisation-dun-autotest-urinaire
- HAS. (2021). Covid-19: quelle place pour les tests antigéniques nasaux dans la stratégie de dépistage ? . Retrieved on 19.03.2021 from https://www.has-sante.fr/jcms/p_3243463/fr/covid-19-quelle-place-pour-les-tests-antigeniques-nasaux-dans-la-strategie-de-depistage