The order adapting French law to the new European regulation published in the Official Journal
The European regulation on medical devices (MD), which came into force on May 26, 2021, required an adaptation of the public health code. Prior to the publication of this order, transitional provisions issued by the "Agence nationale de sécurité du médicament et des produits de santé" (ANSM) and the "Direction générale de la santé" (DGS) applied.
The entry into force of this regulation, which had been postponed for a year due to the health crisis, introduced a reinforcement of the prerequisites necessary to obtain the medical CE mark and higher requirements on the level of demonstration of the benefit/risk of the MD, as well as closer monitoring throughout its life, including after it has been placed on the market.
Overall, the ordinance, consisting of 17 articles, introduces a series of "coordination, repeal and simplification measures necessary to bring the current legislative provisions on medical devices into line with the regulation". It introduces the new definition of MD, which are now distinct from "accessories".
The ordinance also establishes the conditions for placing devices on the market or putting them into service, as well as the procedures for registering certain economic operators and devices not provided for in the Eudamed database.
The text also lists the provisions that apply to MD legally placed on the market before the regulation comes into force in May 2021, to Annex VI products and to research involving the human person (RIPH) that has received the opinion of a CPP before May 2021.
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