{"id":32658,"date":"2022-06-22T14:11:10","date_gmt":"2022-06-22T12:11:10","guid":{"rendered":"https:\/\/www.imds-professional.com\/mdr-specialist-information-2\/"},"modified":"2024-04-04T20:37:05","modified_gmt":"2024-04-04T18:37:05","slug":"mdr-specialist-information","status":"publish","type":"page","link":"https:\/\/www.imds-professional.com\/en\/mdr-specialist-information\/","title":{"rendered":"MDR specialist information"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"32658\" class=\"elementor elementor-32658 elementor-32233\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-310d797 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"310d797\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\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-50 elementor-top-column elementor-element elementor-element-3806531\" data-id=\"3806531\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-a86c7cb elementor-nav-menu__align-start elementor-nav-menu--dropdown-none elementor-widget elementor-widget-nav-menu\" data-id=\"a86c7cb\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;layout&quot;:&quot;vertical&quot;,&quot;sticky&quot;:&quot;top&quot;,&quot;sticky_parent&quot;:&quot;yes&quot;,&quot;submenu_icon&quot;:{&quot;value&quot;:&quot;&lt;i aria-hidden=\\&quot;true\\&quot; class=\\&quot;\\&quot;&gt;&lt;\\\/i&gt;&quot;,&quot;library&quot;:&quot;&quot;},&quot;sticky_on&quot;:[&quot;desktop&quot;],&quot;sticky_offset&quot;:0,&quot;sticky_effects_offset&quot;:0,&quot;sticky_anchor_link_offset&quot;:0}\" data-widget_type=\"nav-menu.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t<nav aria-label=\"Menu\" class=\"elementor-nav-menu--main elementor-nav-menu__container elementor-nav-menu--layout-vertical e--pointer-none\">\n\t\t\t\t<ul id=\"menu-1-a86c7cb\" class=\"elementor-nav-menu sm-vertical\"><li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-32729\"><a href=\"https:\/\/www.imds-professional.com\/en\/mdr-training\/\" class=\"elementor-item\">MDR Training<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-32728\"><a href=\"https:\/\/www.imds-professional.com\/en\/mdr-service\/\" class=\"elementor-item\">MDR Support Services<\/a><\/li>\n<\/ul>\t\t\t<\/nav>\n\t\t\t\t\t\t<nav class=\"elementor-nav-menu--dropdown elementor-nav-menu__container\" aria-hidden=\"true\">\n\t\t\t\t<ul id=\"menu-2-a86c7cb\" class=\"elementor-nav-menu sm-vertical\"><li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-32729\"><a href=\"https:\/\/www.imds-professional.com\/en\/mdr-training\/\" class=\"elementor-item\" tabindex=\"-1\">MDR Training<\/a><\/li>\n<li class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-32728\"><a href=\"https:\/\/www.imds-professional.com\/en\/mdr-service\/\" class=\"elementor-item\" tabindex=\"-1\">MDR Support Services<\/a><\/li>\n<\/ul>\t\t\t<\/nav>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1593ad0 elementor-align-left elementor-widget elementor-widget-button\" data-id=\"1593ad0\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;sticky&quot;:&quot;top&quot;,&quot;sticky_offset&quot;:330,&quot;sticky_parent&quot;:&quot;yes&quot;,&quot;sticky_on&quot;:[&quot;desktop&quot;],&quot;sticky_effects_offset&quot;:0,&quot;sticky_anchor_link_offset&quot;:0}\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm elementor-animation-float\" href=\"https:\/\/www.imds-professional.com\/en\/contact\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" id=\"b385ca18-4b85-46d4-bb4b-571c73a19812\" data-name=\"b922a425-e5e0-4ef1-881c-5748460fd139\" viewBox=\"0 0 30.125 18.1738\"><title>arrow-icon-size3<\/title><path d=\"M29.75,9.3948,21.5281,1.1735a.8479.8479,0,0,0-.601-.261L20.9124.9119a.8526.8526,0,0,0-.5956.2409.8642.8642,0,0,0-.0027,1.23l6.7618,6.7611H.7316a.8566.8566,0,1,0,0,1.7131H27.0759l-6.7591,6.7591a.8576.8576,0,0,0-.0214,1.2113.8462.8462,0,0,0,.61.2583.8949.8949,0,0,0,.621-.2556l8.2233-8.224A.8587.8587,0,0,0,29.75,9.3948Z\" transform=\"translate(0.125 -0.9119)\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Contact<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2ff3192 elementor-align-left elementor-widget elementor-widget-button\" data-id=\"2ff3192\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;sticky&quot;:&quot;top&quot;,&quot;sticky_offset&quot;:440,&quot;sticky_parent&quot;:&quot;yes&quot;,&quot;sticky_on&quot;:[&quot;desktop&quot;],&quot;sticky_effects_offset&quot;:0,&quot;sticky_anchor_link_offset&quot;:0}\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm elementor-animation-float\" href=\"https:\/\/www.imds-professional.com\/en\/current-training-courses\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" id=\"b385ca18-4b85-46d4-bb4b-571c73a19812\" data-name=\"b922a425-e5e0-4ef1-881c-5748460fd139\" viewBox=\"0 0 30.125 18.1738\"><title>arrow-icon-size3<\/title><path d=\"M29.75,9.3948,21.5281,1.1735a.8479.8479,0,0,0-.601-.261L20.9124.9119a.8526.8526,0,0,0-.5956.2409.8642.8642,0,0,0-.0027,1.23l6.7618,6.7611H.7316a.8566.8566,0,1,0,0,1.7131H27.0759l-6.7591,6.7591a.8576.8576,0,0,0-.0214,1.2113.8462.8462,0,0,0,.61.2583.8949.8949,0,0,0,.621-.2556l8.2233-8.224A.8587.8587,0,0,0,29.75,9.3948Z\" transform=\"translate(0.125 -0.9119)\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Seminar booking<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c32053f elementor-align-left elementor-widget elementor-widget-button\" data-id=\"c32053f\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;sticky&quot;:&quot;top&quot;,&quot;sticky_offset&quot;:500,&quot;sticky_parent&quot;:&quot;yes&quot;,&quot;sticky_on&quot;:[&quot;desktop&quot;],&quot;sticky_effects_offset&quot;:0,&quot;sticky_anchor_link_offset&quot;:0}\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm elementor-animation-float\" href=\"https:\/\/www.imds-professional.com\/en\/newsletter\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" id=\"b385ca18-4b85-46d4-bb4b-571c73a19812\" data-name=\"b922a425-e5e0-4ef1-881c-5748460fd139\" viewBox=\"0 0 30.125 18.1738\"><title>arrow-icon-size3<\/title><path d=\"M29.75,9.3948,21.5281,1.1735a.8479.8479,0,0,0-.601-.261L20.9124.9119a.8526.8526,0,0,0-.5956.2409.8642.8642,0,0,0-.0027,1.23l6.7618,6.7611H.7316a.8566.8566,0,1,0,0,1.7131H27.0759l-6.7591,6.7591a.8576.8576,0,0,0-.0214,1.2113.8462.8462,0,0,0,.61.2583.8949.8949,0,0,0,.621-.2556l8.2233-8.224A.8587.8587,0,0,0,29.75,9.3948Z\" transform=\"translate(0.125 -0.9119)\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Newsletter<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\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<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-e65e6da\" data-id=\"e65e6da\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-7db202b elementor-align-left elementor-widget elementor-widget-button\" data-id=\"7db202b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/www.imds-professional.com\/en\/our-areas-of-expertise\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"dticon dticon-arrow-down-outline\"><\/i>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Back to specialist topics<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7487d88 elementor-widget elementor-widget-heading\" data-id=\"7487d88\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\"> <b>Specialist information on MDR<\/b><\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1ed5679 elementor-widget-divider--view-line elementor-invisible elementor-widget elementor-widget-divider\" data-id=\"1ed5679\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeIn&quot;,&quot;_animation_delay&quot;:150}\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8c07343 animated-slow elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"8c07343\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;,&quot;_animation_delay&quot;:100}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Medical Devices Regulation<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ddcf113 elementor-widget elementor-widget-text-editor\" data-id=\"ddcf113\" data-element_type=\"widget\" data-e-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\t\t<p><span style=\"font-weight: 400;\">Manufacturers must comply with a wide range of regulations if they want to sell medical devices on the European market or globally. Some substances and materials are banned in some countries or economic areas such as the EU. There are also many regulations and laws for packaging and transportation. Some requirements apply through the Medical Device Regulation MDR, the\u00a0<\/span><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A32017R0745\" target=\"_blank\" rel=\"noopener\">EU Medical Device Regulation 2017\/745<\/a><span style=\"font-weight: 400;\">. Medical devices can also be affected by the <a href=\"https:\/\/www.imds-professional.com\/en\/eu-rohs-directive-information\/\">RoHS Directive<\/a>, the <a href=\"https:\/\/www.imds-professional.com\/en\/reach-regulation-information\/\">REACH <\/a>chemicals regulation, the POPs regulation, California Proposition 65 or specifications on <a href=\"https:\/\/www.imds-professional.com\/en\/conflict-minerals-regulation-information\/\">conflict minerals<\/a> or the <a href=\"https:\/\/www.imds-professional.com\/en\/scip-database-information\/\">SCIP database<\/a>. In addition, the EU Supply Chain Act and the Dodd-Frank Act impact the industry. We help you navigate this legal jungle and design a safe and efficient material compliance process.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6dee942 elementor-widget elementor-widget-toggle\" data-id=\"6dee942\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"toggle.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1151\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-1151\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\"> Medical Device Regulation: Compliance with the EU MDR<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1151\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-1151\"><p><span style=\"font-weight: 400;\">In May 2021 &#8211; one year later than planned due to the Corona pandemic &#8211; the European&nbsp;<\/span><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A32017R0745\" target=\"_blank\">Medical Devices Regulation 2017\/745\/EU<\/a><span style=\"font-weight: 400;\">, abbreviated MDR, came into force. Since then, manufacturers of medical devices and other players in the supply chain have had to fulfill a wide range of material compliance requirements. Previously, the Medical Device Directive (MDD) 93\/42\/EC and the Active Implantable Medical Devices Directive (90\/385\/EEC) applied. In a sense, the MDR succeeds these legal requirements and has also brought higher material compliance requirements for medical devices in the EU. In addition, the new MDR no longer applies only to products with a medical purpose, but also, for example, to cosmetic and other products such as contact lenses, aesthetic products, and implants.&nbsp;&nbsp;<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The European Database for Medical Devices&nbsp;<\/span><a href=\"https:\/\/ec.europa.eu\/tools\/eudamed\/#\/screen\/home\" target=\"_blank\">EUDAMED<\/a><span style=\"font-weight: 400;\">, which has been mandatory for all EU member states since 2011, will also be expanded as part of the introduction of the MDR. Thus, product-relevant data on every product sold in the EU must be made available in EUDAMED, as well as data on manufacturers, importers or distributors. A uniquely assigned product number, the &#8220;Unique Device Identification&#8221;, was also introduced. This is intended to create transparency in the supply chain and facilitate recalls. In addition, a new symbol has been introduced for medical device labels: the &#8220;MD&#8221; marking.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Since May 2021, products that are not compliant with the substance requirements may no longer be placed on the market. Substances regulated in the MDR must be identified and their presence justified. Otherwise, the technical documentation and consequently the conformity assessment procedure are invalid. Transitional provisions under Article 120, paragraph 2 of the MDR apply until May 27, 2022, or May 27, 2024, until which time certificates of compliance under the previously applicable MDD are still valid and products may be placed on the market, even if they are already subject to MDR regulations. Restrictions also apply to sales: The approval of products placed on the market under the old MDD regulation applicable to medical devices until May 25, 2020, expires on May 27, 2025 &#8211; until then, for example, stock products may still be sold and used.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The so-called Notified Bodies, which are responsible for the certification and conformity assessment of medical devices according to MDR, can, according to the new regulation, carry out unannounced audits at the manufacturers, who are obliged to provide extensive technical documentation. To comply with the new medical device legislation and limit liability risks, manufacturers and suppliers should therefore use workable communication and data exchange systems and also adapt current contracts. This is a comprehensive process that many companies have already underestimated. This is where we can help you with our <a href=\"https:\/\/www.imds-professional.com\/en\/mdr-service\/\">service <\/a>&#8211; even at short notice &#8211; just contact us.&nbsp;<\/span><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1152\" class=\"elementor-tab-title\" data-tab=\"2\" role=\"button\" aria-controls=\"elementor-tab-content-1152\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\"> CMR substances and endocrine disruptors: The scope of the MDR<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1152\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"region\" aria-labelledby=\"elementor-tab-title-1152\"><p><span style=\"font-weight: 400;\">All components of medical devices must be compliant with the new requirements. This means that so-called CMR substances (derived from Carcinogenic, Mutagenic and toxic to Reproduction) may not exceed a proportion of 0.1 percent. The individual materials in the product components are taken as the reference value. For certain areas of application, there are exceptions for higher concentrations of these chemicals (see chapter 10.4.2 of the MDR). CMR substances are substances that have been shown to cause cancer, alter genetic material or endanger reproduction.<\/span><\/p>\n<p><span style=\"font-size: 16px; font-weight: 400;\">Specifically, the MDR regulates the handling of substances described in Annex I, 10.4. as:<\/span><\/p>\n<p><span style=\"font-size: 16px; font-weight: 400;\">&#8220;(a) substances that are carcinogenic, mutagenic or toxic to reproduction (&#8220;CMR substances&#8221;) of category 1A or 1B as defined in Part 3 of Annex VI to Regulation (EC) No. 1272\/2008 of the European Parliament and of the Council&nbsp;<\/span><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/DE\/TXT\/HTML\/?uri=CELEX:32017R0745&amp;from=DE#ntr1-L_2017117DE.01009401-E0001\" target=\"_blank\">(1)<\/a><span style=\"font-size: 16px; font-weight: 400;\">; or<\/span><\/p>\n<p><span style=\"font-size: 16px; font-weight: 400;\">(b) substances with endocrine disrupting properties that have been scientifically identified as likely to have serious effects on human health, either in accordance with the procedure laid down in Article 59 of Regulation (EC) No 1907\/2006 of the European Parliament and of the Council&nbsp;<\/span><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/DE\/TXT\/HTML\/?uri=CELEX:32017R0745&amp;from=DE#ntr2-L_2017117DE.01009401-E0002\" target=\"_blank\">(2)<\/a><span style=\"font-size: 16px; font-weight: 400;\">&nbsp;or, once the Commission has adopted a delegated act in accordance with the first subparagraph of Article 5(3) of Regulation (EU) No 528\/2012 of the European Parliament and of the Council&nbsp;<\/span><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/DE\/TXT\/HTML\/?uri=CELEX:32017R0745&amp;from=DE#ntr3-L_2017117DE.01009401-E0003\" target=\"_blank\">(3)<\/a><span style=\"font-size: 16px; font-weight: 400;\">, in accordance with the criteria relating to human health set out therein.&#8221;<\/span><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1153\" class=\"elementor-tab-title\" data-tab=\"3\" role=\"button\" aria-controls=\"elementor-tab-content-1153\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">To which devices and materials does the MDR apply?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1153\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" role=\"region\" aria-labelledby=\"elementor-tab-title-1153\"><span style=\"font-weight: 400;\">If the following criteria apply to them, products or product components and materials used therein must not exceed a concentration of 0.1% by mass of the substances described in the previous section:<\/span>\r\n<ul>\r\n \t<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">They are used invasively and come into direct contact with the human body.<\/span><\/li>\r\n \t<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">They administer or extract (repeatedly) medicines, body fluids or other substances, including gases, from the body.<\/span><\/li>\r\n \t<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">They transport or store drugs, body fluids or other substances, including gases, which are administered to the body (repeatedly).<\/span><\/li>\r\n<\/ul>\r\n<span style=\"font-weight: 400;\">According to the MDR, manufacturers of such medical devices already have to ensure that their articles meet certain requirements, such as those described in Annex I &#8211; including material requirements &#8211; on safety and performance. Failure to do so could result in a ban from circulation. Only if all provisions are correctly fulfilled, manufacturers will receive a valid CE marking for their articles after an EU declaration of conformity. If you are unsure whether the MDR applies to your products or materials, contact us!<\/span><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1154\" class=\"elementor-tab-title\" data-tab=\"4\" role=\"button\" aria-controls=\"elementor-tab-content-1154\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">Conformity assessment: What are the requirements of the EU MDR?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1154\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"4\" role=\"region\" aria-labelledby=\"elementor-tab-title-1154\"><p><span style=\"font-weight: 400;\">Not all medical device manufacturers have yet adapted to the strict material compliance requirements imposed by the European Medical Device Regulation MDR. This is because these partly require new mechanisms and systems for customer and supplier communication.<\/span><\/p>\n<p><span style=\"font-size: 16px; font-weight: 400;\">Material requirements for articles can be found in the safety and performance requirements in Annex I of the Medical Device Regulation MDR (see Chapter 2, 10.4. Substances). According to the MDR, this evidence is mandatory for the Technical Documentation (see Annex II, 4. Essential Safety and Performance Requirements).<\/span><\/p>\n<p><span style=\"font-size: 16px; font-weight: 400;\">Depending on the risk class to which a product or article has been assigned, a different conformity assessment procedure is provided. For example, a new risk class &#8220;lr&#8221; has been created for reusable surgical instruments. For products in risk classes IIa and IIb as well as III and for some products from class I, a &#8220;Notified Body&#8221; must be involved. For some high-risk products from classes IIb and III, a new consultation procedure (&#8220;scrutiny procedure&#8221;) is also envisaged, in which an independent panel of experts is also involved.<\/span><\/p>\n<p><span style=\"font-size: 16px; font-weight: 400;\">With our <a href=\"https:\/\/www.imds-professional.com\/en\/mdr-service\/\">service and consulting<\/a> on the European Medical Devices Regulation, you will quickly find the information you need on the topics that are relevant to you and will be sure to meet all the requirements.<\/span><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1155\" class=\"elementor-tab-title\" data-tab=\"5\" role=\"button\" aria-controls=\"elementor-tab-content-1155\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">What exemptions apply?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1155\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"5\" role=\"region\" aria-labelledby=\"elementor-tab-title-1155\"><span style=\"font-weight: 400;\">For exemptions to justify use of the persistent organic pollutants above the stated limit, all of the following four criteria must be met:<\/span>\r\n<ul>\r\n \t<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The potential exposure of patient:s or user:s to the substance must be analyzed and estimated.\u00a0\u00a0<\/span><\/li>\r\n \t<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">An analysis of possible alternative available substances, materials or designs is required. This must be based on independent scientific studies and opinions of scientific committees, as well as peer-reviewed studies.\u00a0\u00a0<\/span><\/li>\r\n \t<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Justification must be provided as to why possible substitutes of substances and\/or materials or changes in design, if available or feasible, are not appropriate in terms of functionality, performance and risk-benefit ratio of the product. Sensitive groups of patients must also be taken into account, for example pregnant women, nursing mothers or children, who are considered to be particularly vulnerable with regard to these substances and\/or materials.\u00a0\u00a0<\/span><\/li>\r\n \t<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The most recent guidance from the relevant EU Scientific Committee as set out in sections 10.4.3 (guidance for phthalates) and 10.4.4 (guidance for other CMR substances and substances with endocrine disrupting properties) shall be taken into account.<\/span><\/li>\r\n<\/ul>\r\n<span style=\"font-weight: 400;\">In the case that the products, product components or materials used contain substances in a concentration of more than 0.1 percent by mass that are found in section 10.4.1 or 10.4.1 a or b of the Medical Devices Regulation, there are special labeling requirements according to 10.4.5. The regulated substances must then be named on the products themselves and\/or on the individual packaging or, under certain circumstances, on the sales packaging. In addition to this information, there must be a list of substances. If children, pregnant women, nursing mothers or other groups of patients who are particularly susceptible to these substances and\/or materials are affected, information on risks and precautions must also be included in the instructions for use.\u00a0 <\/span><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1156\" class=\"elementor-tab-title\" data-tab=\"6\" role=\"button\" aria-controls=\"elementor-tab-content-1156\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewBox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewBox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">What other obligations must manufacturers observe?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-1156\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"6\" role=\"region\" aria-labelledby=\"elementor-tab-title-1156\"><p><span style=\"font-weight: 400;\">Manufacturers of medical devices must designate at least one &#8220;qualified person&#8221; in their company who is responsible for compliance with the EU MDR Regulation. For manufacturers located outside the European Economic Area, there is an obligation to designate an authorized person for this purpose. With our consulting services and our service, our Expert:innen team is available to assist with all further steps.<\/span><\/p>\n<p><span style=\"font-size: 16px; font-weight: 400;\">According to the MDR regulation, manufacturers of medical devices must establish a risk management system. In addition, numerous verifications and documentations must be kept &#8211; always against the background that a manufacturing company must be prepared for unannounced audits. Therefore, it is advisable to establish a careful management of data and information. A system for quality management must also be demonstrated in accordance with the MDR regulation.<\/span><\/p>\n<p><span style=\"font-size: 16px; font-weight: 400;\">In all these tasks, the imds professioinal team, which has been a global leader in the field of material compliance for many years, will support you with service and consulting. Simply <a href=\"https:\/\/www.imds-professional.com\/en\/contact\/\">contact us<\/a> for an individual offer or a non-binding initial consultation.<\/span><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/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<\/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>arrow-icon-size3 Contact arrow-icon-size3 Seminar booking arrow-icon-size3 Newsletter Back to specialist topics Specialist information on MDR Medical Devices Regulation Manufacturers must comply with a wide range of regulations if they want to sell medical devices on the European market or globally. Some substances and materials are banned in some countries or economic areas such as the [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-32658","page","type-page","status-publish","hentry","entry","owp-thumbs-layout-horizontal","owp-btn-normal","owp-tabs-layout-horizontal","has-no-thumbnails","has-product-nav"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Medical Devices Regulation<\/title>\n<meta name=\"description\" content=\"Read interesting facts about the Medical Devices Regulation MDR and other regulations for medical devices on the European market.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.imds-professional.com\/en\/mdr-specialist-information\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medical Devices Regulation\" \/>\n<meta property=\"og:description\" content=\"Read interesting facts about the Medical Devices Regulation MDR and other regulations for medical devices on the European market.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.imds-professional.com\/en\/mdr-specialist-information\/\" \/>\n<meta property=\"og:site_name\" content=\"imds-professional\" \/>\n<meta property=\"article:modified_time\" content=\"2024-04-04T18:37:05+00:00\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"10 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.imds-professional.com\\\/en\\\/mdr-specialist-information\\\/\",\"url\":\"https:\\\/\\\/www.imds-professional.com\\\/en\\\/mdr-specialist-information\\\/\",\"name\":\"Medical Devices Regulation\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.imds-professional.com\\\/#website\"},\"datePublished\":\"2022-06-22T12:11:10+00:00\",\"dateModified\":\"2024-04-04T18:37:05+00:00\",\"description\":\"Read interesting facts about the Medical Devices Regulation MDR and other regulations for medical devices on the European market.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/www.imds-professional.com\\\/en\\\/mdr-specialist-information\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/www.imds-professional.com\\\/en\\\/mdr-specialist-information\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/www.imds-professional.com\\\/en\\\/mdr-specialist-information\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Startseite\",\"item\":\"https:\\\/\\\/www.imds-professional.com\\\/en\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"MDR specialist information\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/www.imds-professional.com\\\/#website\",\"url\":\"https:\\\/\\\/www.imds-professional.com\\\/\",\"name\":\"imds-professional\",\"description\":\"Demo Seite f\u00fcr ein Projekt, nicht l\u00f6schen!!! \",\"publisher\":{\"@id\":\"https:\\\/\\\/www.imds-professional.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/www.imds-professional.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/www.imds-professional.com\\\/#organization\",\"name\":\"imds professional GmbH & Co. KG\",\"url\":\"https:\\\/\\\/www.imds-professional.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/www.imds-professional.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/www.imds-professional.com\\\/wp-content\\\/uploads\\\/2021\\\/06\\\/Logo-TransparentHeader.png\",\"contentUrl\":\"https:\\\/\\\/www.imds-professional.com\\\/wp-content\\\/uploads\\\/2021\\\/06\\\/Logo-TransparentHeader.png\",\"width\":5012,\"height\":2111,\"caption\":\"imds professional GmbH & Co. KG\"},\"image\":{\"@id\":\"https:\\\/\\\/www.imds-professional.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"}}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Medical Devices Regulation","description":"Read interesting facts about the Medical Devices Regulation MDR and other regulations for medical devices on the European market.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.imds-professional.com\/en\/mdr-specialist-information\/","og_locale":"en_US","og_type":"article","og_title":"Medical Devices Regulation","og_description":"Read interesting facts about the Medical Devices Regulation MDR and other regulations for medical devices on the European market.","og_url":"https:\/\/www.imds-professional.com\/en\/mdr-specialist-information\/","og_site_name":"imds-professional","article_modified_time":"2024-04-04T18:37:05+00:00","twitter_misc":{"Est. reading time":"10 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.imds-professional.com\/en\/mdr-specialist-information\/","url":"https:\/\/www.imds-professional.com\/en\/mdr-specialist-information\/","name":"Medical Devices Regulation","isPartOf":{"@id":"https:\/\/www.imds-professional.com\/#website"},"datePublished":"2022-06-22T12:11:10+00:00","dateModified":"2024-04-04T18:37:05+00:00","description":"Read interesting facts about the Medical Devices Regulation MDR and other regulations for medical devices on the European market.","breadcrumb":{"@id":"https:\/\/www.imds-professional.com\/en\/mdr-specialist-information\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.imds-professional.com\/en\/mdr-specialist-information\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/www.imds-professional.com\/en\/mdr-specialist-information\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Startseite","item":"https:\/\/www.imds-professional.com\/en\/"},{"@type":"ListItem","position":2,"name":"MDR specialist information"}]},{"@type":"WebSite","@id":"https:\/\/www.imds-professional.com\/#website","url":"https:\/\/www.imds-professional.com\/","name":"imds-professional","description":"Demo Seite f\u00fcr ein Projekt, nicht l\u00f6schen!!! ","publisher":{"@id":"https:\/\/www.imds-professional.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.imds-professional.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/www.imds-professional.com\/#organization","name":"imds professional GmbH & Co. KG","url":"https:\/\/www.imds-professional.com\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.imds-professional.com\/#\/schema\/logo\/image\/","url":"https:\/\/www.imds-professional.com\/wp-content\/uploads\/2021\/06\/Logo-TransparentHeader.png","contentUrl":"https:\/\/www.imds-professional.com\/wp-content\/uploads\/2021\/06\/Logo-TransparentHeader.png","width":5012,"height":2111,"caption":"imds professional GmbH & Co. KG"},"image":{"@id":"https:\/\/www.imds-professional.com\/#\/schema\/logo\/image\/"}}]}},"_links":{"self":[{"href":"https:\/\/www.imds-professional.com\/en\/wp-json\/wp\/v2\/pages\/32658","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.imds-professional.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.imds-professional.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.imds-professional.com\/en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.imds-professional.com\/en\/wp-json\/wp\/v2\/comments?post=32658"}],"version-history":[{"count":0,"href":"https:\/\/www.imds-professional.com\/en\/wp-json\/wp\/v2\/pages\/32658\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.imds-professional.com\/en\/wp-json\/wp\/v2\/media?parent=32658"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}