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.