PLG’s regulatory support for COVID-19 self-tests in France

Throughout the pandemic, COVID-19 self-tests have been an ally in the fight against the virus. The widely used self-tests use a nasal sample to detect SARS-CoV-2, which an individual can carry out in their own home. In Europe, all medical devices require a CE mark to demonstrate compliance with up-to-date European Union (EU) health, safety and performance regulations.

For self-tests in particular, EU regulation requires a notified body to assess the conformity of the device for the CE marking. However, due to the urgency of the situation, a derogation was briefly in place where manufacturers could still market their device while waiting for a CE certificate. This is no longer the case, and the complete CE certification performed by a notified body is now required before placing the product on the market. A validation by the competent authority in France is also required.

Once a CE mark is obtained, a manufacturer can apply for a validation of their self-test to the competent authority. In this case, the device must comply with the country specifications set out by the Haute Autorité de Santé and the Agence nationale de sécurité du médicament et des produits de santé (ANSM). The ANSM review the submission before making recommendations to the Ministry of Health, who if successful will add the device to a list of other approved COVID-19 self-tests. Manufacturers must send all packaging artworks and a summary of clinical data to the ANSM to ensure that all French requirements are being followed.

ProductLife Group (PLG) provided regulatory support to one COVID-19 self-test manufacturer to ensure compliance with current specifications. PLG ensured that packaging was up-to-date with current guidelines, and that instructions clearly demonstrated how to use the self-test, the processing time, and how to read test results. Users needed to be able to read and understand the information to ensure that the device was used correctly. To demonstrate this, a feasibility study was needed to show that a layperson was able to perform the test. In addition, the clinical performance of the nasal swab self-test compared to a suitable comparator (RT PCR on nasopharynges from unfrozen sample) was needed as well as demonstrating that the self-test matched the required sensitivity levels to detect SARS-CoV-2 in a sample.

PLG’s expertise was at the forefront of helping their client gain approval for the much-needed self-test by offering insight into the French specificities and guidelines needed before launching in France. PLG’s dedicated MedTech team worked on the technical file to support the CE mark process and liaised with the notified body during the conformity assessment process, while the regulatory affairs team worked alongside the manufacturer to support country level access and approval. In addition, PLG’s strong network and connection with the ANSM aided in answering any questions and tracking submissions. By utilizing French-specific knowledge, PLG worked swiftly and efficiently to help this COVID-19 self-test manufacturer to get much-needed approval in France, supporting them through each step of the process.

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