In the context of the health emergency in France due to the COVID-19 pandemic, a Decree was issued in order to ensure a bigger availability of COVID detection tests to the laboratories.
Among the measures, a process of derogation from the usual conformity assessment route was adopted for SARS-CoV-2 RT-PCR tests, which allows this type of IVDs (in-vitro diagnostic devices) to reach the laboratories in a faster manner and without CE marking.
However, there are certain conditions to be respected before their placing on the French market:
- The test and its performances shall be validated by the CRN (Centre National de Référence des virus des infections respiratoires);
- The manufacturer/authorized representative/distributor shall approach the French Competent Authority at firstname.lastname@example.org by sending following form together with the IFUs of the device in French language;
- After the submission to the French Competent Authority and validation by the CRN, the conform tests will be listed on a public website.
DPM of Publications Department
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