Faster access of IVDs on the French market

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 dmcdiv@ansm.sante.fr 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.

Ajda Mihelčič

DPM of Publications Department

31.07.2020


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