{"id":52400,"date":"2023-07-24T15:55:09","date_gmt":"2023-07-24T13:55:09","guid":{"rendered":"https:\/\/itechmedicaldivision.com\/?page_id=52400"},"modified":"2023-07-24T15:56:50","modified_gmt":"2023-07-24T13:56:50","slug":"mdr","status":"publish","type":"page","link":"https:\/\/itechmedicaldivision.com\/fr\/mdr\/","title":{"rendered":"MDR: une garantie de s\u00e9curit\u00e9 et de performance."},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"52400\" class=\"elementor elementor-52400 elementor-50657\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-3da6508 elementor-section-full_width elementor-section-stretched elementor-section-height-default elementor-section-height-default\" data-id=\"3da6508\" data-element_type=\"section\" data-settings=\"{&quot;stretch_section&quot;:&quot;section-stretched&quot;,&quot;background_background&quot;:&quot;slideshow&quot;,&quot;background_slideshow_gallery&quot;:[{&quot;id&quot;:52378,&quot;url&quot;:&quot;https:\\\/\\\/itechmedicaldivision.com\\\/wp-content\\\/uploads\\\/Slideshow_MDR_iTech_Giugno_2023_03.png&quot;}],&quot;background_slideshow_slide_duration&quot;:5000,&quot;background_slideshow_slide_transition&quot;:&quot;fade&quot;,&quot;background_slideshow_transition_duration&quot;:500}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-811bdd5\" data-id=\"811bdd5\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-92b10b0 elementor-widget elementor-widget-heading\" data-id=\"92b10b0\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">MDR: une garantie de s\u00e9curit\u00e9 et de performance.<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-2dc0149 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"2dc0149\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-b6803e3\" data-id=\"b6803e3\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-96cbd73 elementor-widget elementor-widget-heading\" data-id=\"96cbd73\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Plus de s\u00e9curit\u00e9 et d'efficacit\u00e9 avec les dispositifs certifi\u00e9s MDR.<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f23772c elementor-widget elementor-widget-text-editor\" data-id=\"f23772c\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><strong>Le Nouveau R\u00e8glement Europ\u00e9en sur les Dispositifs M\u00e9dicaux 2017\/745<\/strong> &#8211; qui est entr\u00e9 en vigueur le 26 mai 2021 &#8211; <strong>\u00e9tablit un r\u00e9gime l\u00e9gislatif plus strict<\/strong>, articul\u00e9 et actualis\u00e9 que la pr\u00e9c\u00e9dente Directive 93\/42\/CEE.<\/p><ul><li><strong>La v\u00e9rification des exigences de s\u00e9curit\u00e9 des dispositifs m\u00e9dicaux<\/strong> ne se limite pas \u00e0 la phase de pr\u00e9certification, mais <strong>doit \u00eatre assur\u00e9e par les fabricants de mani\u00e8re continue<\/strong>, \u00e9galement apr\u00e8s la vente.<\/li><li><strong>Les fabricants sont tenus de garantir les performances des dispositifs<\/strong>, en les contr\u00f4lant au moyen d&#8217;un syst\u00e8me rigoureux de surveillance du march\u00e9.<\/li><li><strong>La tra\u00e7abilit\u00e9 des dispositifs doit \u00eatre assur\u00e9e tout au long de la cha\u00eene de distribution<\/strong>, du fabricant au consommateur final. De cette mani\u00e8re, le dispositif peut \u00eatre rapidement identifi\u00e9 en cas de probl\u00e8me.<\/li><li>Chaque dispositif m\u00e9dical doit faire l&#8217;objet d&#8217;une mise \u00e0 jour clinique: <strong>le fabricant doit garantir son efficacit\u00e9 clinique dans le temps<\/strong> en actualisant la validation clinique \u00e0 l&#8217;aide des donn\u00e9es cliniques du march\u00e9.<\/li><li>Avec l&#8217;entr\u00e9e en vigueur du nouveau r\u00e8glement, <strong>toutes les nouvelles technologies<\/strong> (par exemple les nanomat\u00e9riaux, les substances dangereuses) sont prises en compte et de nouvelles exigences strictes sont introduites pour garantir la s\u00e9curit\u00e9 des dispositifs.<\/li><li>En outre, <strong>de nombreux produits \u00e0 finalit\u00e9 non m\u00e9dicale<\/strong> (lentilles de contact, fillers, appareils de liposuccion, lasers pour traitement dermique, etc.), gr\u00e2ce au MDR, <strong>entrent d\u00e9sormais dans la cat\u00e9gorie des dispositifs m\u00e9dicaux<\/strong>, imposant ainsi \u00e0 leurs fabricants les m\u00eames obligations que celles pr\u00e9vues par le r\u00e8glement.<\/li><\/ul><p>Ce n&#8217;est qu&#8217;une partie <strong>des exigences strictes<\/strong> introduites, qui demandent pr\u00e9cision et rigueur aux fabricants et soulignent <strong>le besoin constant d&#8217;assurer la s\u00e9curit\u00e9 des utilisateurs finaux<\/strong>.<\/p><p>Gr\u00e2ce \u00e0 l&#8217;exp\u00e9rience et au travail acharn\u00e9 de notre \u00e9quipe dans les domaines technique et scientifique, <strong>nous avons \u00e9t\u00e9 les premiers \u00e0 enregistrer les appareils de magn\u00e9toth\u00e9rapie CEMP de la s\u00e9rie LaMagneto dans la base de donn\u00e9es unique europ\u00e9enne EUDAMED<\/strong>, conform\u00e9ment au MDR.<\/p><p>La certification des appareils LaMagneto n&#8217;a pas \u00e9t\u00e9 facile. Il a fallu 16 mois de travail acharn\u00e9 pour certifier les dispositifs m\u00e9dicaux conform\u00e9ment aux nouvelles r\u00e9glementations. Une r\u00e9ussite qui nous rend heureux et fiers car elle nous permet de garantir des dispositifs m\u00e9dicaux encore plus s\u00fbrs et plus fiables.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-86367a3 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"86367a3\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-6f95ded\" data-id=\"6f95ded\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-631eafb elementor-widget elementor-widget-heading\" data-id=\"631eafb\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Restez au courant de l'actualit\u00e9 du MDR.<br \/>Inscrivez-vous \u00e0 notre lettre d'information.<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1da2552 elementor-widget elementor-widget-shortcode\" data-id=\"1da2552\" data-element_type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-shortcode\">\n<div class=\"wpcf7 no-js\" id=\"wpcf7-f52569-o1\" lang=\"fr-FR\" dir=\"ltr\" data-wpcf7-id=\"52569\">\n<div class=\"screen-reader-response\"><p role=\"status\" aria-live=\"polite\" aria-atomic=\"true\"><\/p> <ul><\/ul><\/div>\n<form action=\"\/fr\/wp-json\/wp\/v2\/pages\/52400#wpcf7-f52569-o1\" method=\"post\" class=\"wpcf7-form init\" aria-label=\"Formulaire de contact\" novalidate=\"novalidate\" data-status=\"init\">\n<fieldset class=\"hidden-fields-container\"><input type=\"hidden\" name=\"_wpcf7\" value=\"52569\" \/><input type=\"hidden\" name=\"_wpcf7_version\" value=\"6.1.5\" \/><input type=\"hidden\" name=\"_wpcf7_locale\" value=\"fr_FR\" \/><input type=\"hidden\" name=\"_wpcf7_unit_tag\" value=\"wpcf7-f52569-o1\" \/><input type=\"hidden\" name=\"_wpcf7_container_post\" value=\"0\" \/><input type=\"hidden\" name=\"_wpcf7_posted_data_hash\" value=\"\" \/><input type=\"hidden\" name=\"_wpcf7_recaptcha_response\" value=\"\" \/>\n<\/fieldset>\n<input class=\"wpcf7-form-control wpcf7-hidden\" value=\"MDR\" type=\"hidden\" name=\"your-subject\" \/>\n<input class=\"wpcf7-form-control wpcf7-hidden\" value=\"1\" type=\"hidden\" name=\"mc4wp-subscribe\" \/>\n<input class=\"wpcf7-form-control wpcf7-hidden\" value=\"MDR\" type=\"hidden\" name=\"mc4wp-CAMPAIGN\" \/>\n<p><input class=\"wpcf7-form-control wpcf7-hidden\" type=\"hidden\" name=\"_mc4wp_lists[]\" value=\"77119b20eb\" \/>\n<\/p>\n<div class=\"contact-business-form green\">\n\t<div class=\"row\">\n\t\t<div class=\"col-12 col-md-6\">\n\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"mc4wp-FNAME\"><input size=\"40\" maxlength=\"100\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required form-control\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Nom *\" value=\"\" type=\"text\" name=\"mc4wp-FNAME\" \/><\/span>\n\t\t\t<\/p>\n\t\t<\/div>\n\t\t<div class=\"col-12 col-md-6\">\n\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"mc4wp-LNAME\"><input size=\"40\" maxlength=\"100\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required form-control\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Pr\u00e9nom *\" value=\"\" type=\"text\" name=\"mc4wp-LNAME\" \/><\/span>\n\t\t\t<\/p>\n\t\t<\/div>\n\t<\/div>\n\t<div class=\"row\">\n\t\t<div class=\"col-12 col-md-6\">\n\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"mc4wp-EMAIL\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-email wpcf7-validates-as-required wpcf7-text wpcf7-validates-as-email form-control\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"E-mail *\" value=\"\" type=\"email\" name=\"mc4wp-EMAIL\" \/><\/span>\n\t\t\t<\/p>\n\t\t<\/div>\n\t\t<div class=\"col-12 col-md-6\">\n\t\t\t<p><label for=\"user-type\" class=\"d-block\">Quel type d'utilisateur \u00eates-vous?<\/label><span class=\"wpcf7-form-control-wrap\" data-name=\"mc4wp-MMERGE11\"><select class=\"wpcf7-form-control wpcf7-select wpcf7-validates-as-required custom-select\" id=\"user-type\" aria-required=\"true\" aria-invalid=\"false\" name=\"mc4wp-MMERGE11\"><option value=\"\">&#8212;Veuillez choisir une option&#8212;<\/option><option value=\"M\u00e9decin\">M\u00e9decin<\/option><option value=\"Kin\u00e9sith\u00e9rapeute\">Kin\u00e9sith\u00e9rapeute<\/option><option value=\"Rivenditore - Distributore\">Rivenditore - Distributore<\/option><option value=\"Privato\">Privato<\/option><\/select><\/span>\n\t\t\t<\/p>\n\t\t<\/div>\n\t<\/div>\n\t<div class=\"row\">\n\t\t<div class=\"col-12\">\n\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"privacy\"><span class=\"wpcf7-form-control wpcf7-acceptance\"><span class=\"wpcf7-list-item\"><label><input type=\"checkbox\" name=\"privacy\" value=\"1\" class=\"privacy\" aria-invalid=\"false\" \/><span class=\"wpcf7-list-item-label\">Apr\u00e8s avoir pris connaissance des <a href=\"https:\/\/itechmedicaldivision.com\/fr\/information-consentement-newsletter\/\" title=\"Information et consentement pour la newsletter\" target=\"_blank\">informations<\/a>, je d\u00e9clare vouloir recevoir des communications de la part d'I-Tech Medical Division.<\/span><\/label><\/span><\/span><\/span>\n\t\t\t<\/p>\n\t\t<\/div>\n\t<\/div>\n\t<div class=\"row\">\n\t\t<div class=\"col-md-12\">\n\t\t\t<p><span class=\"wpcf7-form-control-wrap kc_captcha cf7ic-toggle\" data-name=\"kc_captcha\"><span class=\"wpcf7-form-control wpcf7-radio\"><span class=\"captcha-image\" style=\"display: none;\"><span class=\"cf7ic_instructions\">Veuillez prouver que vous \u00eates humain en s\u00e9lectionnant<span> l\u2019avion<\/span>.<\/span><label><input aria-label=\"1\" type=\"radio\" name=\"kc_captcha\" value=\"bot\" \/><svg aria-hidden=\"true\" role=\"img\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 576 512\"><path fill=\"currentColor\" d=\"M259 18l-65 132-146 22c-26 3-37 36-18 54l106 103-25 146c-5 26 23 46 46 33l131-68 131 68c23 13 51-7 46-33l-25-146 106-103c19-18 8-51-18-54l-146-22-65-132a32 32 0 00-58 0z\"\/><\/svg><\/label><label><input aria-label=\"2\" type=\"radio\" name=\"kc_captcha\" value=\"bot\" \/><svg aria-hidden=\"true\" role=\"img\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 512 512\"><path fill=\"currentColor\" d=\"M512 176a176 176 0 01-209 173l-24 27a24 24 0 01-18 8h-37v40c0 13-11 24-24 24h-40v40c0 13-11 24-24 24H24c-13 0-24-11-24-24v-78c0-6 3-13 7-17l162-162a176 176 0 11343-55zm-176-48a48 48 0 1096 0 48 48 0 00-96 0z\"\/><\/svg><\/label><label><input aria-label=\"3\" type=\"radio\" name=\"kc_captcha\" value=\"kc_human\" \/><svg aria-hidden=\"true\" role=\"img\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 576 512\"><path fill=\"currentColor\" d=\"M472 200H360L256 6a12 12 0 00-10-6h-58c-8 0-14 7-12 15l34 185H100l-35-58a12 12 0 00-10-6H12c-8 0-13 7-12 14l21 106L0 362c-1 7 4 14 12 14h43c4 0 8-2 10-6l35-58h110l-34 185c-2 8 4 15 12 15h58a12 12 0 0010-6l104-194h112c57 0 104-25 104-56s-47-56-104-56z\"\/><\/svg><\/label>\r\n    <\/span>\r\n    <span style=\"display:none\">\r\n        <input type=\"text\" name=\"kc_honeypot\">\r\n    <\/span><\/span><\/span>\n\t\t\t<\/p>\n\t\t<\/div>\n\t<\/div>\n\t<div class=\"row\">\n\t\t<div class=\"col-12 mt-3 submit-form\">\n\t\t\t<p><input class=\"wpcf7-form-control wpcf7-submit has-spinner fixfnt\" type=\"submit\" value=\"Envoyer\" \/>\n\t\t\t<\/p>\n\t\t<\/div>\n\t<\/div>\n<\/div><div class=\"wpcf7-response-output\" aria-hidden=\"true\"><\/div>\n<\/form>\n<\/div>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>MDR: une garantie de s\u00e9curit\u00e9 et de performance. Plus de s\u00e9curit\u00e9 et d&#8217;efficacit\u00e9 avec les dispositifs certifi\u00e9s MDR. Le Nouveau [&hellip;]<\/p>\n","protected":false},"author":11,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-templates\/template_fullwidth.php","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-52400","page","type-page","status-publish","hentry","col-lg-4 col-md-6"],"acf":[],"_links":{"self":[{"href":"https:\/\/itechmedicaldivision.com\/fr\/wp-json\/wp\/v2\/pages\/52400","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/itechmedicaldivision.com\/fr\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/itechmedicaldivision.com\/fr\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/itechmedicaldivision.com\/fr\/wp-json\/wp\/v2\/users\/11"}],"replies":[{"embeddable":true,"href":"https:\/\/itechmedicaldivision.com\/fr\/wp-json\/wp\/v2\/comments?post=52400"}],"version-history":[{"count":0,"href":"https:\/\/itechmedicaldivision.com\/fr\/wp-json\/wp\/v2\/pages\/52400\/revisions"}],"wp:attachment":[{"href":"https:\/\/itechmedicaldivision.com\/fr\/wp-json\/wp\/v2\/media?parent=52400"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}