{"id":52376,"date":"2023-07-24T15:49:23","date_gmt":"2023-07-24T13:49:23","guid":{"rendered":"https:\/\/itechmedicaldivision.com\/?page_id=52376"},"modified":"2023-07-24T15:51:48","modified_gmt":"2023-07-24T13:51:48","slug":"mdr","status":"publish","type":"page","link":"https:\/\/itechmedicaldivision.com\/en\/mdr\/","title":{"rendered":"MDR: a guarantee of safety and performance"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"52376\" class=\"elementor elementor-52376 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;:52379,&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: a guarantee of safety and 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\">More safety and effectiveness with MDR certified devices.<\/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>The new European Medical Device Regulation (MDR) 2017\/745<\/strong>, which entered into force on 26th May 2021, <strong>establishes a more stringent, articulated and up-to-date legislative regime<\/strong> compared to the previous Directive 93\/42\/EEC.<\/p><ul><li><strong>The verification of the safety requirements of medical devices<\/strong> is not limited to the pre-certification phase, but <strong>must be guaranteed by the manufacturers on an ongoing basis<\/strong> even after the sale of the product.<\/li><li><strong>Manufacturers are therefore required to guarantee the performance of the devices<\/strong>, monitoring them by way of a rigorous market surveillance system.<\/li><li><strong>The traceability of the devices must be guaranteed along the entire distribution chain<\/strong>, from the manufacturer right through to the final consumer. In this way, the device can be promptly identified in case of any issues.<\/li><li>Every medical device must be clinically updated, with the <strong>manufacturer guaranteeing its clinical efficacy over time<\/strong>, and updating its clinical validation with new clinical data coming from the market.<\/li><li>With the entry into force of the new regulation, <strong>all new technologies are taken into consideration<\/strong>, including, for example, nano-materials and hazardous substances, and new stringent requirements have been introduced to guarantee the safety of the devices.<\/li><li>Furthermore, <strong>many more products intended for non-medical use<\/strong> (e.g. contact lenses, fillers, liposuction devices, dermal treatment lasers), due to the MDR, <strong>are now included in the category of medical devices<\/strong>, thus imposing the same obligations of the new regulation on their manufacturers.<\/li><\/ul><p>This is only part of <strong>the new strict requirements introduced<\/strong>, which require precision and rigour from manufacturing companies, and which <strong>highlight the constant need to guarantee the safety of end-users<\/strong>.<\/p><p>Thanks to the experience and incessant work of our team in technical and scientific fields, <strong>we were the first to register PEMF therapy devices, in our case the LaMagneto series, in the single European database EUDAMED<\/strong> according to MDR.<\/p><p>The certification of the LaMagneto devices has certainly not been easy. The process demanded 16 months of hard work to be able to certify the medical devices in accordance with the new provisions. However, it is a result that makes us very happy and proud, because it allows us to guarantee even safer and more reliable medical devices.<\/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-09388aa elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"09388aa\" 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-6cd496f\" data-id=\"6cd496f\" 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-9ce408a elementor-widget elementor-widget-heading\" data-id=\"9ce408a\" 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\">Stay up-to-date on MDR news. <br \/>Sign up for our newsletter.<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cbbff0a elementor-widget elementor-widget-shortcode\" data-id=\"cbbff0a\" 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-f52565-o1\" lang=\"en-US\" dir=\"ltr\" data-wpcf7-id=\"52565\">\n<div class=\"screen-reader-response\"><p role=\"status\" aria-live=\"polite\" aria-atomic=\"true\"><\/p> <ul><\/ul><\/div>\n<form action=\"\/en\/wp-json\/wp\/v2\/pages\/52376#wpcf7-f52565-o1\" method=\"post\" class=\"wpcf7-form init\" aria-label=\"Contact form\" novalidate=\"novalidate\" data-status=\"init\">\n<fieldset class=\"hidden-fields-container\"><input type=\"hidden\" name=\"_wpcf7\" value=\"52565\" \/><input type=\"hidden\" name=\"_wpcf7_version\" value=\"6.1.5\" \/><input type=\"hidden\" name=\"_wpcf7_locale\" value=\"en_US\" \/><input type=\"hidden\" name=\"_wpcf7_unit_tag\" value=\"wpcf7-f52565-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=\"First name *\" 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=\"Last name *\" 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\">What type of user are you?<\/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;Please choose an option&#8212;<\/option><option value=\"Doctor\">Doctor<\/option><option value=\"Physiotherapist\">Physiotherapist<\/option><option value=\"Dealer - Distributor\">Dealer - Distributor<\/option><option value=\"End user\">End user<\/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 mt-3 submit-form\">\n\t\t\t<p><input class=\"wpcf7-form-control wpcf7-submit has-spinner fixfnt\" type=\"submit\" value=\"Submit\" \/>\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\">Having read the <a href=\"https:\/\/itechmedicaldivision.com\/en\/newsletter-information-consent\/\" title=\"Newsletter information and consent\" target=\"_blank\">information<\/a>, I declare that I wish to receive communications from I-Tech Medical Division.<\/span><\/label><\/span><\/span><\/span>\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: a guarantee of safety and performance. More safety and effectiveness with MDR certified devices. The new European Medical Device [&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-52376","page","type-page","status-publish","hentry","col-lg-4 col-md-6"],"acf":[],"_links":{"self":[{"href":"https:\/\/itechmedicaldivision.com\/en\/wp-json\/wp\/v2\/pages\/52376","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/itechmedicaldivision.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/itechmedicaldivision.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/itechmedicaldivision.com\/en\/wp-json\/wp\/v2\/users\/11"}],"replies":[{"embeddable":true,"href":"https:\/\/itechmedicaldivision.com\/en\/wp-json\/wp\/v2\/comments?post=52376"}],"version-history":[{"count":0,"href":"https:\/\/itechmedicaldivision.com\/en\/wp-json\/wp\/v2\/pages\/52376\/revisions"}],"wp:attachment":[{"href":"https:\/\/itechmedicaldivision.com\/en\/wp-json\/wp\/v2\/media?parent=52376"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}