Question 18208 — health

Summary

Mrs. Agnès Firmin Le Bodo draws the attention of the Minister of Solidarity and Health to the certification of medical devices. Companies manufacturing medical devices must have them certified according to rules laid down by the European Union regulation of April 5, 2017. These have been considerably made more complex than the previous ones (directive 93-42 EEC) in order to guarantee a high level of safety, which is quite legitimate. This Strengthening the rules requires the notified bodies - ON - (which issue certification of medical devices) to reorganize under the responsibility of the Member States who must designate an authority responsible for the notified bodies. However, to date, companies manufacturing medical devices are warning about the delays caused by these modifications despite a transition timetable and derogation measures provided for by the EU. In fact, the ONs do not seem ready overall: very few have already requested the renewal of their approval. Therefore, this risks leading to failures to renew or award certifications without which medical devices cannot be marketed. Concretely, companies could no longer be able to market certain products (supply disruption) or even cease their activity with the consequences that we imagine. Also, it questions it in order to find out what support measures could be put in place to avoid this risk of lack of certification (additional deadlines, aid to ONs to accelerate the obtaining of their approval, transition measures).

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