{"id":6772,"date":"2026-05-28T10:35:51","date_gmt":"2026-05-28T05:05:51","guid":{"rendered":"https:\/\/operonstrategist.com\/?p=6772"},"modified":"2026-05-28T10:35:51","modified_gmt":"2026-05-28T05:05:51","slug":"mdd-to-new-mdr-classification","status":"publish","type":"post","link":"https:\/\/operonstrategist.com\/eg-en\/mdd-to-new-mdr-classification\/","title":{"rendered":"MDD to New MDR Classification of Medical Devices"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"6772\" class=\"elementor elementor-6772\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-15949918 e-flex e-con-boxed e-con e-parent\" data-id=\"15949918\" 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-55e11151 elementor-widget elementor-widget-heading\" data-id=\"55e11151\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">MDD to New MDR Classification of Medical Devices<\/h1>\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-3e167bfe e-flex e-con-boxed e-con e-parent\" data-id=\"3e167bfe\" 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-f97f02e e-con-full e-flex e-con e-child\" data-id=\"f97f02e\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3e8b78a0 elementor-widget elementor-widget-text-editor\" data-id=\"3e8b78a0\" 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>\u00a0<\/p><p><span style=\"font-weight: 400;\">The requirements for MDR classification for medical devices are nearly identical to those in the current Medical Devices Directive (MDD). The<\/span><span style=\"font-weight: 400;\"> EU MDR<\/span><span style=\"font-weight: 400;\"> is shaking up the medical device business, and the order regulations have not been left spotless. The MDR decides on the device\u2019s congruency assessment course. While the order is primarily concerned with the maker, if the device falls into Classes IIa, IIb, or III, it includes recommendations for the Notified body.<\/span><\/p><p><span style=\"font-weight: 400;\">Before medical device makers may legally CE stamp their products in Europe, they must agree to the EU Commission\u2019s fitting medical device order or guidelines. Before CE marking your products, you must first determine the correct medical device classification. CE marking is a conformity assessment of a product that confirms that it is safe and effective by the standards. As a <a href=\"https:\/\/operonstrategist.com\/elevateplus\/ce-marking-eu-mdr-ivdr\/\">CE mark<\/a> medical device consultant, we understand how important it is for your product to be CE-marked in the EU market. A classification affects the administrative requirements for your devices, as well as the endorsement course and its accompanying expenses.<\/span><\/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-20132b93 e-con-full e-flex e-con e-child\" data-id=\"20132b93\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-7bb8c6c3 e-con-full e-flex e-con e-child\" data-id=\"7bb8c6c3\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4d71e799 elementor-widget elementor-widget-heading\" data-id=\"4d71e799\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Regulatory Excellence for Global Medical Device Markets<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7e4e5600 elementor-widget elementor-widget-wpforms\" data-id=\"7e4e5600\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"wpforms.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"wpforms-container wpforms-container-full wpforms-render-modern\" id=\"wpforms-6203\"><form id=\"wpforms-form-6203\" class=\"wpforms-validate wpforms-form wpforms-ajax-form\" data-formid=\"6203\" method=\"post\" enctype=\"multipart\/form-data\" action=\"\/eg-en\/wp-json\/wp\/v2\/posts\/6772\" data-token=\"ee4c630135566a9aa4fb09bfe9a12c8c\" data-token-time=\"1780085115\"><noscript class=\"wpforms-error-noscript\">Please enable JavaScript in your browser to complete this form.<\/noscript><div id=\"wpforms-error-noscript\" style=\"display: none;\">Please enable JavaScript in your browser to complete this form.<\/div><div class=\"wpforms-field-container\"><div id=\"wpforms-6203-field_1-container\" class=\"wpforms-field wpforms-field-name\" data-field-id=\"1\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_1\" aria-hidden=\"false\">Name <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"text\" id=\"wpforms-6203-field_1\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][1]\" placeholder=\"Name*\" aria-errormessage=\"wpforms-6203-field_1-error\" required><\/div><div id=\"wpforms-6203-field_2-container\" class=\"wpforms-field wpforms-field-email\" data-field-id=\"2\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_2\" aria-hidden=\"false\">Email <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"email\" id=\"wpforms-6203-field_2\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][2]\" placeholder=\"Email*\" spellcheck=\"false\" aria-errormessage=\"wpforms-6203-field_2-error\" required><\/div>\t\t<div id=\"wpforms-6203-field_5-container\"\n\t\t\tclass=\"wpforms-field wpforms-field-text\"\n\t\t\tdata-field-type=\"text\"\n\t\t\tdata-field-id=\"5\"\n\t\t\t>\n\t\t\t<label class=\"wpforms-field-label\" for=\"wpforms-6203-field_5\" >Paragraph Phone Email<\/label>\n\t\t\t<input type=\"text\" id=\"wpforms-6203-field_5\" class=\"wpforms-field-medium\" name=\"wpforms[fields][5]\" >\n\t\t<\/div>\n\t\t<div id=\"wpforms-6203-field_3-container\" class=\"wpforms-field wpforms-field-phone\" data-field-id=\"3\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_3\" aria-hidden=\"false\">Phone <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"tel\" id=\"wpforms-6203-field_3\" class=\"wpforms-field-large wpforms-field-required wpforms-smart-phone-field\" data-rule-smart-phone-field=\"true\" name=\"wpforms[fields][3]\" placeholder=\"Phone*\" aria-label=\"Phone\" aria-errormessage=\"wpforms-6203-field_3-error\" required><\/div><div id=\"wpforms-6203-field_4-container\" class=\"wpforms-field wpforms-field-textarea\" data-field-id=\"4\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_4\" aria-hidden=\"false\">Paragraph Text <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><textarea id=\"wpforms-6203-field_4\" class=\"wpforms-field-medium wpforms-field-required\" name=\"wpforms[fields][4]\" placeholder=\"Message\" aria-errormessage=\"wpforms-6203-field_4-error\" required><\/textarea><\/div><script>\n\t\t\t\t( function() {\n\t\t\t\t\tconst style = document.createElement( 'style' );\n\t\t\t\t\tstyle.appendChild( document.createTextNode( '#wpforms-6203-field_5-container { position: absolute !important; overflow: hidden !important; display: inline !important; height: 1px !important; width: 1px !important; z-index: -1000 !important; padding: 0 !important; } #wpforms-6203-field_5-container input { visibility: hidden; } #wpforms-conversational-form-page #wpforms-6203-field_5-container label { counter-increment: none; }' ) );\n\t\t\t\t\tdocument.head.appendChild( style );\n\t\t\t\t\tdocument.currentScript?.remove();\n\t\t\t\t} )();\n\t\t\t<\/script><\/div><!-- .wpforms-field-container --><div class=\"wpforms-submit-container\" ><input type=\"hidden\" name=\"wpforms[id]\" value=\"6203\"><input type=\"hidden\" name=\"page_title\" value=\"\"><input type=\"hidden\" name=\"page_url\" value=\"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/posts\/6772\"><input type=\"hidden\" name=\"url_referer\" value=\"\"><button type=\"submit\" name=\"wpforms[submit]\" id=\"wpforms-submit-6203\" class=\"wpforms-submit\" data-alt-text=\"Sending...\" data-submit-text=\"Submit\" aria-live=\"assertive\" value=\"wpforms-submit\">Submit<\/button><img decoding=\"async\" src=\"https:\/\/operonstrategist.com\/wp-content\/plugins\/wpforms\/assets\/images\/submit-spin.svg\" class=\"wpforms-submit-spinner\" style=\"display: none;\" width=\"26\" height=\"26\" alt=\"Loading\"><\/div><\/form><\/div>  <!-- .wpforms-container -->\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\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-3d377399 e-flex e-con-boxed e-con e-parent\" data-id=\"3d377399\" 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-39b9ffb7 elementor-widget elementor-widget-text-editor\" data-id=\"39b9ffb7\" 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><span style=\"font-weight: 400;\">The number of rules in the MDR classes has increased from 18 to 22, and additional adjustments have been made to existing standards, resulting in numerous new classifications. One of the most significant changes to the EU MDR that medical device manufacturers will notice as they work to comply with the new guidelines is a modification in the conditions for device classes. Manufacturers\u2019 requirements change when the classification of medical equipment changes. The MDR will apply to specific products not directed by the MDD, such as non-corrective contact lenses.2 The MDR will also seldom handle devices connecting nonmaterials and devices made from non-feasible human tissue, which are now exempt from the MDD.<\/span><\/p><p><span style=\"font-weight: 400;\">With new rules come classification adjustments that affect individual devices. All dynamic implanted devices and accessories will be classified as Class III. Any substance-based devices intended to be used through a body orifice or applied to the skin may not be class I, hence any substance-based devices currently categorized as class I will be reclassified under the new law. Any producer with a gadget that will be up-classified under the MDR must agree to the tighter requirements and will most likely need to draw in their body more. The MDR designation indicates that the goods are specifically designed for the cleaning, disinfection, or sterilization of medical devices.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f1cd396 elementor-widget elementor-widget-heading\" data-id=\"f1cd396\" 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\">EU MDR classifications For Medical Devices\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8a1d483 elementor-widget elementor-widget-text-editor\" data-id=\"8a1d483\" 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><span style=\"font-weight: 400;\">One of the first concerns for medical device makers looking to commercialize their products in Europe is determining which classes are appropriate for their devices.<\/span><\/p><p><span style=\"font-weight: 400;\">The MDR categorization of the devices will influence how and when you communicate with your Notified Body. As the market transitions from the Medical Devices Directives (MDD) and Active Implantable Medical Devices to the Medical Devices Regulation, device manufacturers must be aware of the changes in device classification criteria. For example, devices that used to be regulated by the Active Implantable Medical Device Directives (MDD) are now under the Medical Device Regulation (MDR).<\/span><\/p><p>Also Read <a href=\"https:\/\/operonstrategist.com\/examples-of-medical-device-classifications\/\">Examples of Medical Devices As per Classifications<\/a>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-80d063d elementor-widget elementor-widget-heading\" data-id=\"80d063d\" 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\">Medical Device Classification As Per MDR\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-242045b elementor-widget elementor-widget-text-editor\" data-id=\"242045b\" 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><span style=\"font-weight: 400;\">As per MDR Article, 51 Medical Devices are divided into classes I, IIa, IIb, and class III, taking into account the intended purpose of the devices and their inherent risks. Medical Device classifications are mainly based on the following factors:<\/span><\/p><p><span style=\"font-weight: 400;\">The Medical Devices Classification in the European Union\u2019s new MDR is outlined in ANNEX VIII, Chapter I, and the classification Rule is mentioned in Chapter III. This chapter includes definitions of the terminology used in the medical devices guidance document for the classification of Medical Devices.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c9c7ba8 elementor-widget elementor-widget-heading\" data-id=\"c9c7ba8\" 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\">The Medical Device is classified into:\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fd23568 elementor-widget elementor-widget-text-editor\" data-id=\"fd23568\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Class I<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Class I Sterile<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Class I Measuring<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Class I Reusable<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Class IIa<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Class IIb<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Class III<\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-20418a9 elementor-widget elementor-widget-heading\" data-id=\"20418a9\" 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\">EU MDR Medical Device Classification Rules\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5cede3c elementor-widget elementor-widget-text-editor\" data-id=\"5cede3c\" 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><span style=\"font-weight: 400;\">The Medical Device Classification EU rules, which are based on the vulnerability of the human body, should take into account the potential risks associated with the technical design and manufacture of the devices.<\/span><\/p><p><span style=\"font-weight: 400;\">You\u2019ll find all those rules on the Medical Device Regulation MDR 2017\/745 Annex VIII<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Rule 1\u2013 Non-invasive devices<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Rule 2 \u2013 Non-invasive devices intended for channeling or storing (Which includes cells)<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Rule 3 \u2013 Non-invasive devices that modify the biological or chemical composition of blood, body liquids, other liquids, and cells<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Rule 4 \u2013 Non-invasive devices in contact with injured skin or mucous membrane<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Rule 5 \u2013 Devices invasive in body orifices<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Rule 6 \u2013 Surgically invasive devices for transient use<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Rule 7 \u2013 Surgically invasive devices for short-term use<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Rule 8 \u2013 Surgically invasive devices for long-term use and implantable (including any device administering medicinal products, surgical mesh, or spinal disc)<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Rule 9 \u2013 Active therapeutic devices intended to exchange or administer energy<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Rule 10 \u2013 Active devices for diagnosis &amp; monitoring, emit ionizing radiation<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Rule 11 \u2013 Software intended to provide information that is used to make decisions with diagnosis or therapeutic purposes (from class I to class III)<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Rule 12 \u2013 Active devices intended to administer and\/or remove medicinal products, body-liquids or other substances<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Rule 13 \u2013 All other active devices<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Rule 14 \u2013 Devices incorporating a medicinal substance including human blood or plasma<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Rule 15 \u2013 Contraception or prevention of the transmission of sexually transmitted diseases<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Rule 16 \u2013 Specific disinfecting, cleaning, and rinsing devices<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Rule 17 \u2013 Devices specifically intended for recording of diagnostic images generated by X-ray radiation<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Rule 18 \u2013 Devices utilizing non-viable tissues or cells of human origin or tissues of animals or derivatives.<\/span><\/li><\/ul><h4><span style=\"font-weight: 400;\">Four new rules:<\/span><\/h4><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Rule 19 \u2013 Devices incorporating or consisting of nonmaterial<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Rule 20 \u2013 Invasive devices concerning body orifices to administer medicinal products by inhalation<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Rule 21 \u2013 Substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Rule 22 \u2013 Active therapeutic devices with an integrated or incorporated diagnostic function that significantly determines patient management.<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">Adjustments to the medical device classification system are less challenging than those for IVDs, but makers need nevertheless make considerable improvements. Many of these progressions are the result of previous instructions that did not take into account the degree of obtrusiveness and probable toxicity of specific devices. The MDR classification of devices is divided into four categories: class I, class IIa, class IIb, and class III. They are classified based on 23 principles that consider their capability, risk to patients, and the manufacturer\u2019s intended application. There is a special set of classification guidelines for four distinct types of medical devices: non-obtrusive, intrusive, dynamic, and unusual principles for innovative devices that include various substances. Medical device manufacturers should understand that it is critical to accurately classify these devices from the outset since it dictates production requirements, clinical assessment, and congruity evaluation. To be vigilant, manufacturers should survey all current and prospective products to ensure compliance with the new classification system.<\/span><\/p><p><span style=\"font-weight: 400;\">Need help with medical device classification and regulatory submissions? We provide expert guidance on medical device classification and regulatory compliance, including support for <\/span><a href=\"https:\/\/operonstrategist.com\/elevateplus\/cdsco-india\/\"><span style=\"font-weight: 400;\">CDSCO<\/span><\/a><span style=\"font-weight: 400;\"> and<\/span><a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/fda-510k\/\"><span style=\"font-weight: 400;\"> FDA 510(k)<\/span><\/a><span style=\"font-weight: 400;\"> submissions. Reach out to <\/span><a href=\"https:\/\/operonstrategist.com\/contact-us\/\"><span style=\"font-weight: 400;\">learn more<\/span><\/a><span style=\"font-weight: 400;\"> about how we can assist with your regulatory requirements.<\/span><\/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<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>The requirements for MDR classification for medical devices are nearly identical to those in the current Medical Devices Directive (MDD). The EU MDR is shaking up the medical device business, and the order regulations have not been left spotless. The MDR decides on the device\u2019s congruency assessment course. While the order is primarily concerned with [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":6773,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[55],"tags":[],"class_list":["post-6772","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulatory"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/posts\/6772","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/comments?post=6772"}],"version-history":[{"count":0,"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/posts\/6772\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/media\/6773"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/media?parent=6772"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/categories?post=6772"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/tags?post=6772"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}