{"id":7994,"date":"2025-02-26T15:49:15","date_gmt":"2025-02-26T07:49:15","guid":{"rendered":"https:\/\/regask.com\/?p=7994"},"modified":"2025-02-28T18:07:26","modified_gmt":"2025-02-28T10:07:26","slug":"exemption-de-marquage-ce-france-ansm","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/france-ansm-ce-mark-exemption\/","title":{"rendered":"L&#039;ANSM (France) clarifie le processus d&#039;exemption du marquage CE pour\u2026"},"content":{"rendered":"<p>Sur <strong>27 janvier 2025<\/strong>, le <strong>Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM)<\/strong> en France a publi\u00e9 une mise \u00e0 jour cl\u00e9 concernant le processus d&#039;obtention <strong>Exemptions du marquage CE<\/strong> pour les dispositifs m\u00e9dicaux. Cette pr\u00e9cision r\u00e9glementaire pr\u00e9cise les conditions sp\u00e9cifiques dans lesquelles les fabricants peuvent demander l&#039;autorisation de commercialiser des dispositifs m\u00e9dicaux en France <strong>sans certification CE<\/strong>, qui est g\u00e9n\u00e9ralement requis pour confirmer la conformit\u00e9 avec <strong>Normes de s\u00e9curit\u00e9 et de performance de l&#039;UE<\/strong>.<\/p>\n<p>L&#039;ANSM souligne que ces d\u00e9rogations sont accord\u00e9es <strong>seulement dans des circonstances exceptionnelles<\/strong>, principalement pour prot\u00e9ger <strong>Sant\u00e9 publique et s\u00e9curit\u00e9 des patients<\/strong>, conform\u00e9ment \u00e0 <strong>Article 59 du r\u00e8glement UE 2017\/745<\/strong>.<\/p>\n<p>Les d\u00e9rogations au marquage CE sont strictement limit\u00e9es aux situations o\u00f9 il existe un besoin imp\u00e9rieux de sant\u00e9 publique ou un probl\u00e8me de s\u00e9curit\u00e9 des patients. Pour \u00eatre \u00e9ligibles, les fabricants doivent d\u00e9montrer <strong>b\u00e9n\u00e9fice significatif pour le patient<\/strong>, appuy\u00e9 par des donn\u00e9es de s\u00e9curit\u00e9 et de performance, et prouvent que <strong>aucun produit alternatif<\/strong> sont disponibles sur le march\u00e9.<\/p>\n<p>La mise \u00e0 jour d\u00e9crit deux types d\u2019exemptions. <strong>Exemptions individuelles<\/strong> s&#039;appliquent \u00e0 des patients sp\u00e9cifiques en fonction de besoins m\u00e9dicaux urgents, tandis que <strong>exemptions globales<\/strong> couvrent des cas plus larges mais restent <strong>\u00e0 dur\u00e9e limit\u00e9e et \u00e0 port\u00e9e restreinte<\/strong>Les professionnels de sant\u00e9 utilisant des dispositifs sous d\u00e9rogation doivent informer les patients de l&#039;absence de marquage CE, obtenir leur consentement explicite et signaler tout incident ou risque li\u00e9 \u00e0 l&#039;utilisation du dispositif.<\/p>\n<p>L&#039;ANSM \u00e9valuera les demandes <strong>au cas par cas<\/strong>, en veillant \u00e0 ce que les exemptions demeurent <strong>exceptionnel<\/strong> et ne contournez pas <strong>voies r\u00e9glementaires standard<\/strong>, y compris des investigations cliniques.<\/p>\n<p>Les fabricants et les prestataires de soins de sant\u00e9 impliqu\u00e9s dans la fourniture ou l&#039;utilisation de dispositifs m\u00e9dicaux en France doivent examiner attentivement les directives mises \u00e0 jour de l&#039;ANSM pour s&#039;assurer <strong>conformit\u00e9<\/strong> et <strong>documentation appropri\u00e9e<\/strong> lorsqu\u2019on demande une d\u00e9rogation.<\/p>\n<p>Pour plus de d\u00e9tails, consultez la publication officielle de l&#039;ANSM sur <strong>Exemptions du marquage CE<\/strong>.<\/p>","protected":false},"excerpt":{"rendered":"<p>On January 27, 2025, the National Security Agency of Medicines and Health Products (ANSM) in France issued a key update regarding the process for obtaining CE mark exemptions for medical devices. This regulatory clarification outlines the specific conditions under which manufacturers can seek approval to market medical devices in France without CE certification, which is&#8230;<\/p>","protected":false},"author":30,"featured_media":8074,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[509,39],"tags":[165,602],"class_list":["post-7994","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-france-regulations","category-medical-devices-insights","tag-public-health","tag-import-and-export-regs"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>France ANSM Updates CE Mark Exemption Process | RegASK<\/title>\n<meta name=\"description\" content=\"France\u2019s ANSM clarifies CE mark exemption rules for medical devices, ensuring compliance &amp; patient safety. Read more at RegASK.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/fr\/exemption-de-marquage-ce-france-ansm\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ANSM (France) Clarifies CE Mark Exemption Process for Medical Devices\" \/>\n<meta property=\"og:description\" content=\"France\u2019s ANSM clarifies CE mark exemption rules for medical devices, ensuring compliance &amp; patient safety. 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