Question 18839 — businesses

Summary

Mr. Fabrice Le Vigoureux alerts the Minister of Europe and Foreign Affairs about the medical company I2M, located at 16 bis Fossés Saint Julien in Caen, in Calvados, managed by MM. Desnos and Hamel. For more than 30 years, I2M has been at the origin, thanks to its studies and investigations, of the creation and marketing of the first devices to treat and stop hyperhidrosis, characterized by excessive sweating of the hands, feet and armpits. If the effectiveness of the treatment protocol is no longer to be proven, it becomes problematic to meet national and international demand. The reason for this difficulty in fulfilling orders lies in the scarcity of notified bodies, the only ones competent to carry out an assessment of the conformity of medical devices, and thus issue laboratories with a CE certificate of conformity. valid for a period of 1 to 5 years. Furthermore, during this period, the notified body is responsible for verifying at least every year that the requirements continue to be met, with a thorough check at the end of the period when the certificate is renewed. However, if in 2012 there were 87 organizations in the European Union, today there are estimated to be between 25 and 30 and only one is French-speaking. The decrease in the number of notified bodies is partly explained by the tightening of the criteria for authorization of approval. Indeed, the new European regulations, 2017/745/EU and 2017/746/EU published in the Official Journal in May 2017, state “new technical and regulatory requirements for manufacturers”. Thus, organizations must deal with a growing need for laboratories that must imperatively validate their innovation or verify that the requirements continue to be met. Faced with these increasing demands, some organizations have even decided to no longer accept new clients, thus placing these companies in a delicate position. Also, he asks what levers can be implemented to allow laboratories to market their products by meeting the requirements of notified bodies within the set deadlines and thus limit this obstacle to commercialization and French innovation.

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