Further to the previous publications by the French High Health Authority (HAS), the French Health Ministry published on 21 May 2020 the list of serological tests deemed reliable and validated by the National Reference Centre for respiratory infection viruses (CNR) on its Covid-19 platform (see our previous post here).
On the same date, a new order was published providing (and confirming) that:
- In vitro diagnostic medical devices (IVDs) that detect antibodies against SARS-CoV-2 through serological testing are subject to specific performance assessment procedures.
- Any natural or legal person engaged in the manufacture, marketing, distribution or import of such devices must declare it to the National Agency for Medicines and Health Products Safety (ANSM) through their website (the form for both CE mark and non-CE mark IVDs are available on the ANSM website).
- The declaration must include either a CE conformity declaration or the device’s leaflet if it is CE marked (or both). If not, only the device’s leaflet must be attached.
- On the basis of the documentation provided regarding the device’s composition and performance, the CNR will assess it in the light of the HAS specifications.
- After ANSM’s document verification procedure and the CNR’s scientific evaluations, a list of complying IVDs will be published on the French Health Ministry and the ANSM websites.
- Only the CE marked IVDs that are listed on the platform may be purchased, supplied and used by medical biology laboratories. In the event of non-compliance, the biologist may be held liable.
- In the event of non-compliance with the procedure set out in the order, ANSM may take any measures relating to the IVDs concerned.
In addition, another order and decree came into force on 29 May 2020 regarding serological tests reimbursements. They will be 100% reimbursed, provided that they comply with the HAS’ specifications and they are CE marked and evaluated by the CNR for the following uses:
- As an adjunct diagnosis to a negative RT-PCR test for a symptomatic person.
- A posteriori, when a person no longer presents symptoms but has never been tested positive by RT-PCR. Confirming this infection may help prevent subsequent complications.
- For healthcare workers, given their particular exposure to the virus and their contact with vulnerable population.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, July 2020 Issue (Thomson Reuters).