Published on: Tue 26 May 2020

France published draft law for COVID-19 serological tests

The French government has published a draft legislative text for 'in vitro diagnostic medical devices detecting atibodies against SARS-CoV-2 through serological testing'; in short, for COVID-19 serological tests. 

 

Following the notification, the draft text provides that:

  • In vitro diagnostic medical devices detecting antibodies against SARS-CoV-2 through serological testing are subject to an evaluation procedure;
  • Any natural or legal person engaged in the manufacture, placing on the market, distribution or import of such devices must make a declaration to the National Agency for the Safety of Medicines and Health Products [Agence nationale de sécurité du médicaments et des produits de santé – ANSM];
  • Such a declaration must include the declaration of CE conformity and/or the product leaflet;
  • In vitro diagnostic medical devices are evaluated by the National Reference Centre for Respiratory Viruses;
  • After verification by the ANSM of the documents accompanying the declaration, and on the basis of scientific evaluations carried out by the National Centre, a list of in vitro diagnostic medical devices conforming to the standards set by the National Authority for Health is established;
  • Only in vitro diagnostic medical devices on this list may be purchased and used by clinical laboratories.

The full draft order can be read here


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