{"id":13466,"date":"2023-07-31T11:37:32","date_gmt":"2023-07-31T11:37:32","guid":{"rendered":"https:\/\/www.icemedics.com\/evolution-des-dispositifs-medicaux-ce\/"},"modified":"2023-10-17T10:17:30","modified_gmt":"2023-10-17T10:17:30","slug":"evolution-des-dispositifs-medicaux-ce","status":"publish","type":"page","link":"https:\/\/www.icemedics.com\/fr\/evolution-des-dispositifs-medicaux-ce\/","title":{"rendered":"\u00c9volution des dispositifs m\u00e9dicaux CE"},"content":{"rendered":"

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\u00c9volution des dispositifs m\u00e9dicaux CE<\/h1>\n

Identification unique de produit (UDI)<\/h2>\n

L’UDI, acronyme d’Identification unique de produit, est un code, num\u00e9rique ou alphanum\u00e9rique, qui lui est propre et qui est attribu\u00e9 \u00e0 un produit m\u00e9dical. Il remplit une fonction essentielle en permettant d’identifier de mani\u00e8re indubitable des produits sp\u00e9cifiques sur le march\u00e9, facilitant ainsi leur tra\u00e7abilit\u00e9.<\/p>\n

L’UDI se compose de deux \u00e9l\u00e9ments cl\u00e9s :<\/p>\n

    \n
  • un identifiant de produit (UDI-DI)<\/li>\n
  • un identifiant de production (UDI-PI).<\/li>\n<\/ul>\n

    Ces \u00e9l\u00e9ments ouvrent la porte \u00e0 des informations pr\u00e9cieuses sur le produit. Les avantages sp\u00e9cifiques de l’UDI sont multiples :<\/p>\n

      \n
    • Am\u00e9lioration de l’efficacit\u00e9 de la tra\u00e7abilit\u00e9 des produits.<\/li>\n
    • Facilitation des rappels de produits.<\/li>\n
    • Pr\u00e9vention de la contrefa\u00e7on (MRD Article 123(3)(f), Article 27(4)).<\/li>\n
    • Renforcement de la s\u00e9curit\u00e9 des patients.<\/li>\n<\/ul>\n

      L’UDI-DI de base joue un r\u00f4le central dans la base de donn\u00e9es et la documentation associ\u00e9e (tels que les certificats, les d\u00e9clarations de conformit\u00e9, la documentation technique et les r\u00e9sum\u00e9s sur la s\u00e9curit\u00e9 et la performance clinique). Il servira \u00e9galement de cl\u00e9 d’acc\u00e8s aux informations li\u00e9es aux produits stock\u00e9es dans la future base de donn\u00e9es europ\u00e9enne des produits m\u00e9dicaux.<\/p>\n

      Ce nouveau syst\u00e8me UDI am\u00e9liorera consid\u00e9rablement la tra\u00e7abilit\u00e9 des produits m\u00e9dicaux. Parall\u00e8lement, il renforcera les processus de post-commercialisation li\u00e9s \u00e0 la s\u00e9curit\u00e9 des produits, ce qui permettra aux autorit\u00e9s comp\u00e9tentes d’assurer un suivi plus efficace.<\/p>\n

      L’obligation d’adopter le syst\u00e8me UDI entrera en vigueur le 26 mai 2025 (MRD ARTICLE 123(3)(F), ARTICLE 27 (4)).<\/p>\n

      L’article 27 du r\u00e8glement 2017\/745 et l’article 24 du r\u00e8glement 746\/2017 d\u00e9taillent les \u00e9l\u00e9ments du syst\u00e8me UDI, \u00e0 savoir :<\/p>\n

        \n
      • La cr\u00e9ation d’un UDI comprenant un identifiant de produit (UDI-DI) sp\u00e9cifique \u00e0 un fabricant et \u00e0 un produit, facilitant l’acc\u00e8s aux informations, ainsi qu’un identifiant de production (UDI-PI) qui identifie l’unit\u00e9 de production du produit et, le cas \u00e9ch\u00e9ant, les produits emball\u00e9s.<\/li>\n
      • L’apposition de l’UDI sur l’\u00e9tiquette du produit ou sur son emballage.<\/li>\n
      • Le stockage de l’UDI par les acteurs \u00e9conomiques, les \u00e9tablissements de sant\u00e9 et les professionnels de la sant\u00e9.<\/li>\n
      • La mise en place d’un syst\u00e8me \u00e9lectronique d’identification unique des produits (la \u00ab\u00a0base de donn\u00e9es UDI\u00a0\u00bb).<\/li>\n<\/ul>\n

        En ce qui concerne les gants jetables, ils peuvent \u00eatre class\u00e9s dans l’une des cat\u00e9gories suivantes :<\/p>\n

          \n
        • Cat\u00e9gorie I<\/li>\n
        • Cat\u00e9gorie I m\u00e9dicale<\/li>\n
        • Cat\u00e9gorie III – EPI (\u00c9quipement de Protection Individuelle)<\/li>\n
        • Double cat\u00e9gorie : Cat\u00e9gorie I m\u00e9dicale et Cat\u00e9gorie III – EPI.<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n

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          \n
          \n
          \n

          Certifications pour la qualit\u00e9 des produits<\/h2>\n

           <\/p>\n<\/div>\n<\/div>\n<\/div>\n

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          \u00c9volution des dispositifs m\u00e9dicaux CE Identification unique de produit (UDI) L’UDI, acronyme d’Identification unique de produit, est un code, num\u00e9rique ou alphanum\u00e9rique, qui lui est propre et qui est attribu\u00e9 \u00e0 un produit m\u00e9dical. Il remplit une fonction essentielle en permettant d’identifier de mani\u00e8re indubitable des produits sp\u00e9cifiques sur le march\u00e9, facilitant ainsi leur tra\u00e7abilit\u00e9. […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"class_list":["post-13466","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.icemedics.com\/fr\/wp-json\/wp\/v2\/pages\/13466","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.icemedics.com\/fr\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.icemedics.com\/fr\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.icemedics.com\/fr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.icemedics.com\/fr\/wp-json\/wp\/v2\/comments?post=13466"}],"version-history":[{"count":0,"href":"https:\/\/www.icemedics.com\/fr\/wp-json\/wp\/v2\/pages\/13466\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.icemedics.com\/fr\/wp-json\/wp\/v2\/media?parent=13466"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}