{"id":470,"date":"2026-02-04T18:19:01","date_gmt":"2026-02-04T18:19:01","guid":{"rendered":"https:\/\/medstock.it\/reglementation\/"},"modified":"2026-03-26T10:37:22","modified_gmt":"2026-03-26T10:37:22","slug":"reglementation","status":"publish","type":"page","link":"https:\/\/medstock.it\/fr\/reglementation\/","title":{"rendered":"R\u00e9glementation"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"470\" class=\"elementor elementor-470 elementor-72\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2ec9871 e-con-full e-flex e-con e-parent\" data-id=\"2ec9871\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-535e26f elementor-widget elementor-widget-heading\" data-id=\"535e26f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">R\u00e9glementation<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-de62559 elementor-widget elementor-widget-heading\" data-id=\"de62559\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\">Un bref r\u00e9sum\u00e9 de la r\u00e9glementation IUD<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ab8dbd0 elementor-widget elementor-widget-spacer\" data-id=\"ab8dbd0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-2d8e158 e-flex e-con-boxed e-con e-parent\" data-id=\"2d8e158\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-35fa87a e-con-full e-flex e-con e-child\" data-id=\"35fa87a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5223192 elementor-widget elementor-widget-text-editor\" data-id=\"5223192\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<h4 data-path-to-node=\"8\"><b data-path-to-node=\"8\" data-index-in-node=\"0\">1. L\u2019obligation d\u2019enregistrement IUD<\/b><\/h4><p data-path-to-node=\"9\">Le d\u00e9cret (<a href=\"https:\/\/www.gazzettaufficiale.it\/eli\/id\/2023\/07\/18\/23A04010\/sg\">D.lgs 11\/05\/2023<\/a>) impose aux professionnels de sant\u00e9 d\u2019<b data-path-to-node=\"9\" data-index-in-node=\"48\">enregistrer et de conserver l\u2019identifiant unique (IUD)<\/b> des dispositifs m\u00e9dicaux re\u00e7us et utilis\u00e9s (avec une attention particuli\u00e8re pour les dispositifs implantables et de classe D pour le diagnostic in vitro). L\u2019objectif de la loi est de garantir une tra\u00e7abilit\u00e9 totale, du fabricant jusqu\u2019\u00e0 l\u2019utilisation sur le patient, afin d\u2019intervenir rapidement en cas de lots d\u00e9fectueux. <\/p><h4 data-path-to-node=\"10\"><b data-path-to-node=\"10\" data-index-in-node=\"0\">2. Conservation des donn\u00e9es jusqu\u2019\u00e0 15 ans<\/b><\/h4><p data-path-to-node=\"11\">La loi ne fait aucune concession sur les d\u00e9lais : les registres des codes IUD (incluant les lots et les dates de p\u00e9remption) doivent \u00eatre conserv\u00e9s pendant un minimum de <b data-path-to-node=\"11\" data-index-in-node=\"137\">10 ans<\/b>, une p\u00e9riode qui s\u2019\u00e9l\u00e8ve \u00e0 <b data-path-to-node=\"11\" data-index-in-node=\"165\">15 ans pour les dispositifs m\u00e9dicaux implantables<\/b>. Confier une telle quantit\u00e9 de donn\u00e9es \u00e0 des registres papier ou \u00e0 des fichiers Excel locaux revient \u00e0 s\u2019exposer \u00e0 un risque tr\u00e8s \u00e9lev\u00e9 de perte, d\u2019usure ou de vol des donn\u00e9es. Le l\u00e9gislateur lui-m\u00eame recommande la conservation par voie \u00e9lectronique.  <\/p><h4 data-path-to-node=\"12\"><b data-path-to-node=\"12\" data-index-in-node=\"0\">3. Amendes de 4\u202f000 \u20ac \u00e0 24\u202f500 \u20ac<\/b><\/h4><p data-path-to-node=\"13\">Le non-respect de ces obligations n\u2019est pas pris \u00e0 la l\u00e9g\u00e8re. Comme \u00e9tabli par le D.Lgs 137\/2022 connexe, l\u2019absence ou l\u2019erreur d\u2019enregistrement des codes IUD expose le professionnel de sant\u00e9 ou la clinique \u00e0 des <b data-path-to-node=\"13\" data-index-in-node=\"202\">sanctions administratives tr\u00e8s lourdes, allant de 4\u202f000 \u20ac \u00e0 24\u202f500 \u20ac<\/b>. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-effaf3f e-con-full e-flex e-con e-child\" data-id=\"effaf3f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-52fe906 elementor-widget elementor-widget-text-editor\" data-id=\"52fe906\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<h4 data-path-to-node=\"14\"><b data-path-to-node=\"14\" data-index-in-node=\"0\">Comment MedStock garantit votre conformit\u00e9 (Z\u00e9ro Stress)<\/b><\/h4><p data-path-to-node=\"15\">Au lieu de remplir d\u2019interminables registres manuels avec la peur de commettre des erreurs, <b data-path-to-node=\"15\" data-index-in-node=\"80\">MedStock automatise tout le processus r\u00e9glementaire<\/b> :<\/p><ul data-path-to-node=\"16\"><li><p data-path-to-node=\"16,0,0\"><b data-path-to-node=\"16,0,0\" data-index-in-node=\"0\">Saisie instantan\u00e9e :<\/b> Scannez le code-barres sur l\u2019emballage. MedStock lit et d\u00e9compose automatiquement le code IUD (IUD-ID et IUD-IP). <\/p><\/li><li><p data-path-to-node=\"16,1,0\"><b data-path-to-node=\"16,1,0\" data-index-in-node=\"0\">Archivage s\u00e9curis\u00e9 dans le Cloud :<\/b> Vos donn\u00e9es sont sauvegard\u00e9es sur des serveurs cloud, \u00e0 l\u2019abri des pertes ou des pannes de votre ordinateur local, et conserv\u00e9es dans le temps en parfait accord avec les 10\/15 ans requis par la loi.<\/p><\/li><li><p data-path-to-node=\"16,2,0\"><b data-path-to-node=\"16,2,0\" data-index-in-node=\"0\">Pr\u00eat pour les inspections :<\/b> En cas de contr\u00f4le par les autorit\u00e9s comp\u00e9tentes, un clic suffit pour exporter et pr\u00e9senter l\u2019int\u00e9gralit\u00e9 de l\u2019historique de tra\u00e7abilit\u00e9 requis par le Minist\u00e8re.<\/p><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-d74404e e-flex e-con-boxed e-con e-parent\" data-id=\"d74404e\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-9aff8ea e-con-full e-flex e-con e-child\" data-id=\"9aff8ea\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-95cd55c elementor-widget elementor-widget-spacer\" data-id=\"95cd55c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3f652ba elementor-widget elementor-widget-heading\" data-id=\"3f652ba\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">D\u00e9lais de saisie de l\u2019IUD<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a8d7a96 elementor-pagination-type-bullets elementor-arrows-position-inside elementor-pagination-position-outside elementor-widget elementor-widget-n-carousel\" data-id=\"a8d7a96\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;carousel_items&quot;:[{&quot;slide_title&quot;:&quot;Slide #2&quot;,&quot;_id&quot;:&quot;e33d317&quot;},{&quot;slide_title&quot;:&quot;Slide #2&quot;,&quot;_id&quot;:&quot;ff808b3&quot;},{&quot;slide_title&quot;:&quot;Slide #2&quot;,&quot;_id&quot;:&quot;e14445e&quot;},{&quot;slide_title&quot;:&quot;Slide #2&quot;,&quot;_id&quot;:&quot;8ff2daf&quot;}],&quot;slides_to_show_tablet&quot;:&quot;2&quot;,&quot;slides_to_show_mobile&quot;:&quot;1&quot;,&quot;autoplay&quot;:&quot;yes&quot;,&quot;autoplay_speed&quot;:5000,&quot;pause_on_hover&quot;:&quot;yes&quot;,&quot;pause_on_interaction&quot;:&quot;yes&quot;,&quot;infinite&quot;:&quot;yes&quot;,&quot;speed&quot;:500,&quot;offset_sides&quot;:&quot;none&quot;,&quot;arrows&quot;:&quot;yes&quot;,&quot;pagination&quot;:&quot;bullets&quot;,&quot;image_spacing_custom&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:10,&quot;sizes&quot;:[]},&quot;image_spacing_custom_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;image_spacing_custom_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-carousel.default\">\n\t\t\t\t\t\t\t<div class=\"e-n-carousel swiper\" role=\"region\" aria-roledescription=\"carousel\" aria-label=\"Carosello\" dir=\"ltr\">\n\t\t\t<div class=\"swiper-wrapper\" aria-live=\"off\">\n\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" data-slide=\"1\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"1 sur 4\">\n\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-f191456 e-flex e-con-boxed e-con e-child\" data-id=\"f191456\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c288d12 elementor-widget elementor-widget-heading\" data-id=\"c288d12\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">2017<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-be713a2 elementor-widget elementor-widget-heading\" data-id=\"be713a2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\">r\u00e8glement UE relatif aux dispositifs m\u00e9dicaux<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-256ce0a elementor-widget elementor-widget-text-editor\" data-id=\"256ce0a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>imm\u00e9diatement op\u00e9rationnel bien qu\u2019une mise en \u0153uvre progressive soit pr\u00e9vue (art. 121) avec une r\u00e9\u00e9valuation des r\u00e9sultats obtenus pr\u00e9vue pour le 27 mai 2027<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" data-slide=\"2\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"2 sur 4\">\n\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5a0c283 e-flex e-con-boxed e-con e-child\" data-id=\"5a0c283\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3cedd2b elementor-widget elementor-widget-heading\" data-id=\"3cedd2b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">2023<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fda231c elementor-widget elementor-widget-heading\" data-id=\"fda231c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\">D.Lgs. n\u00b0 137\/22 \u00e0 l\u2019art. 15<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e67543a elementor-widget elementor-widget-text-editor\" data-id=\"e67543a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>obligation d\u2019identification, de tra\u00e7abilit\u00e9 et de nomenclature des dispositifs<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" data-slide=\"3\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"3 sur 4\">\n\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-59f81fb e-flex e-con-boxed e-con e-child\" data-id=\"59f81fb\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-baabe76 elementor-widget elementor-widget-heading\" data-id=\"baabe76\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">2024<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bed6443 elementor-widget elementor-widget-heading\" data-id=\"bed6443\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\">Obligation d\u2019enregistrement IUD<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d52b1f5 elementor-widget elementor-widget-text-editor\" data-id=\"d52b1f5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>\u00c0 partir du 15 janvier, entr\u00e9e en vigueur de l\u2019obligation d\u2019enregistrement et de conservation de l\u2019IUD<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"swiper-slide\" data-slide=\"4\" role=\"group\" aria-roledescription=\"slide\" aria-label=\"4 sur 4\">\n\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-00588aa e-flex e-con-boxed e-con e-child\" data-id=\"00588aa\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5f55d08 elementor-widget elementor-widget-heading\" data-id=\"5f55d08\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">2027<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-658b79f elementor-widget elementor-widget-heading\" data-id=\"658b79f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\">\u00c9ch\u00e9ance pour les DM sans IUD<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bd50507 elementor-widget elementor-widget-text-editor\" data-id=\"bd50507\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Le 31 d\u00e9cembre est la date limite de circulation des dispositifs m\u00e9dicaux sans code IUD<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<div class=\"elementor-swiper-button elementor-swiper-button-prev\" role=\"button\" tabindex=\"0\" aria-label=\"Pr\u00e9c\u00e9dent\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-eicon-chevron-left\" viewBox=\"0 0 1000 1000\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M646 125C629 125 613 133 604 142L308 442C296 454 292 471 292 487 292 504 296 521 308 533L604 854C617 867 629 875 646 875 663 875 679 871 692 858 704 846 713 829 713 812 713 796 708 779 692 767L438 487 692 225C700 217 708 204 708 187 708 171 704 154 692 142 675 129 663 125 646 125Z\"><\/path><\/svg>\t\t\t<\/div>\n\t\t\t<div class=\"elementor-swiper-button elementor-swiper-button-next\" role=\"button\" tabindex=\"0\" aria-label=\"Suivant\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-eicon-chevron-right\" viewBox=\"0 0 1000 1000\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M696 533C708 521 713 504 713 487 713 471 708 454 696 446L400 146C388 133 375 125 354 125 338 125 325 129 313 142 300 154 292 171 292 187 292 204 296 221 308 233L563 492 304 771C292 783 288 800 288 817 288 833 296 850 308 863 321 871 338 875 354 875 371 875 388 867 400 854L696 533Z\"><\/path><\/svg>\t\t\t<\/div>\n\t\t\t\t\t<div class=\"swiper-pagination\"><\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-4854d4d e-flex e-con-boxed e-con e-parent\" data-id=\"4854d4d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-aec21d6 elementor-widget elementor-widget-video\" data-id=\"aec21d6\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;youtube_url&quot;:&quot;https:\\\/\\\/www.youtube.com\\\/watch?v=ePl1zw9N_yQ&quot;,&quot;autoplay&quot;:&quot;yes&quot;,&quot;mute&quot;:&quot;yes&quot;,&quot;loop&quot;:&quot;yes&quot;,&quot;video_type&quot;:&quot;youtube&quot;}\" data-widget_type=\"video.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-wrapper elementor-open-inline\">\n\t\t\t<div class=\"elementor-video\"><\/div>\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d8c6ff5 elementor-widget elementor-widget-text-editor\" data-id=\"d8c6ff5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Avec l\u2019entr\u00e9e en vigueur de la nouvelle r\u00e9glementation europ\u00e9enne <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj\/eng\">UE Medical Device Regulation (EU MDR)<\/a> sur la tra\u00e7abilit\u00e9 des dispositifs m\u00e9dicaux, les professionnels de sant\u00e9 sont tenus de :<\/p><ul><li>V\u00e9rifier l\u2019\u00e9tiquetage <strong>IUD (Unique Device Identification)<\/strong> sur tous les dispositifs m\u00e9dicaux utilis\u00e9s dans la pratique clinique.<\/li><li>Enregistrer et documenter l\u2019IUD des dispositifs utilis\u00e9s sur les patients. <\/li><\/ul><p> <\/p><p>Le terme <strong>\u00ab dispositif m\u00e9dical \u00bb<\/strong> couvre une vaste gamme d\u2019objets, incluant les appareils et \u00e9quipements en contact direct avec le patient \u00e0 des fins de diagnostic ou de traitement d\u2019une condition clinique, et inclut par cons\u00e9quent de nombreux instruments couramment utilis\u00e9s par les m\u00e9decins.<\/p><p>Les \u00e9ch\u00e9ances de conformit\u00e9 \u00e0 la <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj\/eng\">r\u00e9glementation MDR<\/a> concernant le codage IUD des dispositifs m\u00e9dicaux varient selon la classe du dispositif, laquelle est d\u00e9termin\u00e9e par le niveau de risque associ\u00e9.<\/p><p>En particulier, les dispositifs de classe III pr\u00e9sentent un risque \u00e9lev\u00e9 pour le patient.<\/p><ul><li><strong>Classe III<\/strong> : inclut des dispositifs tels que les stimulateurs cardiaques implantables, les g\u00e9n\u00e9rateurs d\u2019impulsions, les tests de diagnostic pour le VIH, les d\u00e9fibrillateurs externes automatis\u00e9s, les implants endosseux et les lentilles de contact \u00e0 usage prolong\u00e9.<\/li><li><strong>Classe II<\/strong> a \/ b : comprend des dispositifs tels que les aiguilles d\u2019acupuncture, les lentilles de contact journali\u00e8res, les fauteuils roulants motoris\u00e9s, les pompes \u00e0 perfusion, les champs chirurgicaux et les syst\u00e8mes de transpondeurs \u00e0 radiofr\u00e9quence implantables pour l\u2019identification du patient et des informations de sant\u00e9.<\/li><li><strong>Classe I<\/strong> : inclut des dispositifs \u00e0 faible risque tels que les bandes \u00e9lastiques, les gants en latex et les instruments chirurgicaux portatifs.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-316c08c elementor-align-center elementor-invisible elementor-widget elementor-widget-button\" data-id=\"316c08c\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInDown&quot;}\" data-widget_type=\"button.default\">\n\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/www.gazzettaufficiale.it\/eli\/id\/2023\/07\/18\/23A04010\/sg\" target=\"_blank\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">D.Lgs. n\u00b0 137\/22 <\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-db7d5c8 elementor-widget elementor-widget-spacer\" data-id=\"db7d5c8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-facf8bc elementor-widget elementor-widget-html\" data-id=\"facf8bc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t\t<div class=\"table-responsive\"><table class=\"table mb-0 table\"><tbody><tr class=\"table-light\"><th scope=\"row\">5 mai 2017<\/th><td>Publication du r\u00e8glement UE<\/td><td>Codage du dispositif m\u00e9dical<\/td><td>Marquage direct du dispositif m\u00e9dical<\/td><td>Codage du dispositif m\u00e9dical de diagnostic in vitro<\/td><\/tr><tr class=\"table-success\"><th scope=\"row\">26 mai 2020<\/th><td>Attribution de l\u2019IUD et enregistrement sur <a href=\"https:\/\/ec.europa.eu\/tools\/eudamed\/\">EUDAMED<\/a><\/td><td><\/td><td><\/td><td><\/td><\/tr><tr class=\"table-info\"><th scope=\"row\">26 mai 2021<\/th><td><\/td><td>Classe III DM<\/td><td><\/td><td><\/td><\/tr><tr class=\"table-warning\"><th scope=\"row\">26 mai 2023<\/th><td><\/td><td>Classe II a\/b DM<\/td><td>Classe III DM<\/td><td>Classe D DIV<\/td><\/tr><tr class=\"table-danger\"><th scope=\"row\">26 mai 2025<\/th><td><\/td><td>Classe I DM<\/td><td>Classe II a\/b DM<\/td><td>Classe C&amp;B DIV<\/td><\/tr><tr class=\"table-primary\"><th scope=\"row\">26 mai 2027<\/th><td><\/td><td><\/td><td>Classe I DM<\/td><td>Classe A DIV<\/td><\/tr><\/tbody><\/table><\/div>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>R\u00e9glementation Un bref r\u00e9sum\u00e9 de la r\u00e9glementation IUD 1. L\u2019obligation d\u2019enregistrement IUD Le d\u00e9cret (D.lgs 11\/05\/2023) impose aux professionnels de sant\u00e9 d\u2019enregistrer et de conserver l\u2019identifiant unique (IUD) des dispositifs m\u00e9dicaux re\u00e7us et utilis\u00e9s (avec une attention particuli\u00e8re pour les dispositifs implantables et de classe D pour le diagnostic in vitro). L\u2019objectif de la loi [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-470","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/medstock.it\/fr\/wp-json\/wp\/v2\/pages\/470","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medstock.it\/fr\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/medstock.it\/fr\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/medstock.it\/fr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/medstock.it\/fr\/wp-json\/wp\/v2\/comments?post=470"}],"version-history":[{"count":1,"href":"https:\/\/medstock.it\/fr\/wp-json\/wp\/v2\/pages\/470\/revisions"}],"predecessor-version":[{"id":471,"href":"https:\/\/medstock.it\/fr\/wp-json\/wp\/v2\/pages\/470\/revisions\/471"}],"wp:attachment":[{"href":"https:\/\/medstock.it\/fr\/wp-json\/wp\/v2\/media?parent=470"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}