{"id":6509,"date":"2026-05-21T17:38:30","date_gmt":"2026-05-21T12:08:30","guid":{"rendered":"https:\/\/operonstrategist.com\/?p=6509"},"modified":"2026-05-21T17:56:55","modified_gmt":"2026-05-21T12:26:55","slug":"eu-regulations-for-marketing-medical-device-combination-products","status":"publish","type":"post","link":"https:\/\/operonstrategist.com\/eg-en\/eu-regulations-for-marketing-medical-device-combination-products\/","title":{"rendered":"Deciphering EU Regulations for Combination Products to Market Medical Devices"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"6509\" class=\"elementor elementor-6509\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4d54ea47 e-flex e-con-boxed e-con e-parent\" data-id=\"4d54ea47\" 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-5d001125 e-con-full e-flex e-con e-child\" data-id=\"5d001125\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b73cc11 elementor-widget elementor-widget-heading\" data-id=\"b73cc11\" 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\">Deciphering EU Regulations for Combination Products to Market Medical Devices<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-424bf988 elementor-widget elementor-widget-text-editor\" data-id=\"424bf988\" 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;\">Welcome to a guide simplifying regulatory rules for Medical Device Combination Products. These unique hybrids revolutionize healthcare, but sticking to regulations is crucial.\u00a0<\/span><span style=\"font-weight: 400;\">Imagine devices and meds teaming up for better treatments. But getting these innovations out there isn\u2019t simple. Regulations ensure they\u2019re safe and effective. Navigating this means understanding evolving rules.\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">In this article, we\u2019ll demystify the compliance process for Medical Device Combination Products, providing valuable insights for manufacturers, healthcare professionals, and anyone curious about regulatory requirements.<\/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-175d4b3a e-con-full e-flex e-con e-child\" data-id=\"175d4b3a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-12e93f0c e-con-full e-flex e-con e-child\" data-id=\"12e93f0c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5d0eba88 elementor-widget elementor-widget-heading\" data-id=\"5d0eba88\" 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\">talk to our experts<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-16aac062 elementor-widget elementor-widget-wpforms\" data-id=\"16aac062\" 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\/6509\" data-token=\"7f8a20c3dd3e3b1bd4f9e19ac0d7fb18\" data-token-time=\"1779369630\"><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>\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\" >Email Phone Paragraph<\/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_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><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\/6509\"><input type=\"hidden\" name=\"url_referer\" value=\"https:\/\/operonstrategist.com\/eg-en\/eu-regulations-for-marketing-medical-device-combination-products\/\"><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-4ad500e e-flex e-con-boxed e-con e-parent\" data-id=\"4ad500e\" 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-725c33ab elementor-widget elementor-widget-heading\" data-id=\"725c33ab\" 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\">Definition of Medical Device Combination Products\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-13189842 elementor-widget elementor-widget-text-editor\" data-id=\"13189842\" 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;\">Medical Device Combination Products, as defined in CFR, encompass combinations of medical devices, drugs, and\/or biologics. These components can be physically combined or packaged together for use. These products leverage the strengths of each component for enhanced therapeutic benefits.\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">Take drug-eluting stents (DES) as a drug-device combination product example. It involves a medical device\u2014a metal scaffold placed in arteries\u2014and a drug coating. The device props open arteries, while the drug prevents scar tissue growth. This synergy embodies CFR\u2019s concept of combining medical devices and drugs for improved treatment outcomes.\u00a0<\/span><\/p><p><i><span style=\"font-weight: 400;\">Need more information about drug-device combination products? Please refer to our service page. <\/span><\/i><a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/design-and-development-documentation\/drug-device-combination-products\/\"><i><span style=\"font-weight: 400;\">Drug-Device Combination Product Consultant<\/span><\/i><\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c52584f elementor-widget elementor-widget-heading\" data-id=\"c52584f\" 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\">Choosing the Market: US vs. EU Regulatory Differences\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0da329c elementor-widget elementor-widget-text-editor\" data-id=\"0da329c\" 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;\">When deciding where to launch Medical Device Combination Products, remember the regulatory rules in the United States (US) and the European Union (EU). The US has simpler rules thanks to the Office of Combination Products (OCP). But the EU has a more complicated path since there\u2019s no exact category for these products, making sorting out rules and submissions more complex.\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">For those planning to bring their combination product to the European Market, you\u2019ll find the following information beneficial. <\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7c4251b elementor-widget elementor-widget-heading\" data-id=\"7c4251b\" 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\">Primary Mode of Action (PMOA) Determination\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ee8428a elementor-widget elementor-widget-text-editor\" data-id=\"ee8428a\" 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;\">Within the EU\u2019s regulatory framework, \u201cPrimary Mode of Action\u201d (PMOA) is a crucial concept for Medical Device Combination Products. It signifies the main intended function of a product \u2013 whether as a medical device or a medicinal product. This determination directs the regulatory path:\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">Medical Device PMOA: Falls under the <\/span><a href=\"https:\/\/operonstrategist.com\/elevateplus\/ce-marking-eu-mdr-ivdr\/\"><span style=\"font-weight: 400;\">EU Medical Device Regulation<\/span><\/a><span style=\"font-weight: 400;\"> (MDR) or <\/span><a href=\"https:\/\/operonstrategist.com\/in-vitro-diagnostic-medical-device-regulation\/\"><span style=\"font-weight: 400;\">In Vitro Diagnostic Regulation<\/span><\/a><span style=\"font-weight: 400;\"> (IVDR), complying with device guidelines and assessed by notified bodies. <\/span><span style=\"font-weight: 400;\">Medicinal Product PMOA: Assessed by the European Medicines Agency (EMA) like other medicinal products. <\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c5af79b elementor-widget elementor-widget-heading\" data-id=\"c5af79b\" 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\">Navigating EU Regulatory Pathways for Medical Device Combination Products\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e97a324 elementor-widget elementor-widget-text-editor\" data-id=\"e97a324\" 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;\">When introducing Medical Device Combination Products to the European market, the regulatory journey is influenced by the unique nature of these products. Notably, the absence of a specific category for such products presents distinct challenges. Here\u2019s a concise overview:\u00a0<\/span><\/p><ol><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Primary Mode of Action (PMOA) Determination: Define whether your product primarily functions as a medical device, drug, biologic, or a combination of these elements. This decision guides subsequent regulatory steps.\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Regulatory Classification: Based on the PMOA, classify your product under relevant regulations \u2013 medical device, drug, or biology.\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Conformance to GSPR and CE Mark: If categorized as a medical device, ensure adherence to the general safety and performance requirements (GSPR) outlined in Annex I of EU MDR 2017\/745. Attain a CE Mark from a notified body (NB) as proof of compliance<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Approval of Ancillary Medicines: Products containing ancillary medicines, like drug-eluting stents, require approval for these medicines from the European Medicines Agency (EMA).\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Interaction between Notified Body and EMA: Notified bodies may consult EMA\u2019s scientific opinion for specific cases, such as substances from human blood\/plasma or those previously evaluated by EMA.\u00a0<br \/><br \/><\/span><\/li><\/ol><p><span style=\"font-weight: 400;\">This collaborative approach ensures that ancillary medicines meet rigorous standards for quality, safety, and effectiveness. Despite the intricate regulatory landscape due to the absence of a specific category, this pathway guarantees that Medical Device Combination Products fulfill the highest standards for patient well-being and product efficacy within the European Union.\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-226680f elementor-widget elementor-widget-heading\" data-id=\"226680f\" 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\">Ensuring Compatibility and Coherence for Medical Device Combination Products\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-46982f6 elementor-widget elementor-widget-text-editor\" data-id=\"46982f6\" 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;\">Within the realm of Medical Device Combination Products, ensuring compatibility and coherence involves the seamless integration of diverse components. This encompasses the alignment of the medical device, drug elements, and any ancillary factors. The objective is to establish a cohesive functioning wherein all constituents operate harmoniously to attain the designated therapeutic outcomes.<\/span><\/p><p><span style=\"font-weight: 400;\"> This necessitates rigorous testing, comprehensive evaluation, and collaboration among specialized experts across various domains, such as medical devices and pharmaceuticals. By upholding compatibility and coherence, the resultant product maintains its safety, efficacy, and overall functionality, thereby delivering enhanced healthcare solutions to patients.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-03eef30 elementor-widget elementor-widget-heading\" data-id=\"03eef30\" 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\">How Can Operon Strategies Help You Market Medical Device Combination Products in the EU?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-858341e elementor-widget elementor-widget-text-editor\" data-id=\"858341e\" 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;\">Operon Strategist, with over a decade of close collaboration with various regulatory agencies, is your partner in effectively marketing Medical Device Combination Products in the EU. With our regulatory expertise, we guide you through classification, compliance, and <\/span><a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/ce-marking\/\"><span style=\"font-weight: 400;\">CE Mark certification<\/span><\/a><span style=\"font-weight: 400;\">. Trust <\/span><a href=\"https:\/\/operonstrategist.com\/\"><span style=\"font-weight: 400;\">Operon Strategist<\/span><\/a><span style=\"font-weight: 400;\"> to ensure your product meets high-quality standards while reaching your target audience with precision.<\/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<div class=\"elementor-element elementor-element-171cb886 e-con-full e-flex e-con e-child\" data-id=\"171cb886\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ac74a8d elementor-widget elementor-widget-heading\" data-id=\"ac74a8d\" 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\">FAQ<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3bc13ab5 elementor-widget elementor-widget-n-accordion\" data-id=\"3bc13ab5\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1000\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1000\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What are combination products under EU regulations? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1000\" class=\"elementor-element elementor-element-8b04207 e-con-full e-flex e-con e-child\" data-id=\"8b04207\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-16d5db1b elementor-widget elementor-widget-text-editor\" data-id=\"16d5db1b\" 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 data-start=\"148\" data-end=\"308\">Combination products are products that combine a medical device with a medicinal product, biologic, or drug component to achieve their intended medical purpose.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1001\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"2\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1001\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Which EU regulation applies to combination products? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1001\" class=\"elementor-element elementor-element-585b9163 e-con-full e-flex e-con e-child\" data-id=\"585b9163\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-597ba8a5 elementor-widget elementor-widget-text-editor\" data-id=\"597ba8a5\" 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>Combination products in Europe are primarily regulated under the EU Medical Device Regulation (EU MDR 2017\/745) and may also involve pharmaceutical regulatory requirements depending on the product type.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1002\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"3\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1002\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What are examples of medical device combination products? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1002\" class=\"elementor-element elementor-element-5c3f7f29 e-con-full e-flex e-con e-child\" data-id=\"5c3f7f29\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-71508bb9 elementor-widget elementor-widget-text-editor\" data-id=\"71508bb9\" 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 data-start=\"649\" data-end=\"673\">Common examples include:<\/p><ul data-start=\"674\" data-end=\"781\"><li data-section-id=\"fjatc2\" data-start=\"674\" data-end=\"697\">Drug-eluting stents<\/li><li data-section-id=\"d0vzyn\" data-start=\"698\" data-end=\"720\">Prefilled syringes<\/li><li data-section-id=\"1fo4ju\" data-start=\"721\" data-end=\"737\">Insulin pens<\/li><li data-section-id=\"uk1acu\" data-start=\"738\" data-end=\"750\">Inhalers<\/li><li data-section-id=\"1lxxl8r\" data-start=\"751\" data-end=\"781\">Transdermal delivery systems<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1003\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"4\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1003\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> How are combination products classified in the EU? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1003\" class=\"elementor-element elementor-element-256b7d99 e-con-full e-flex e-con e-child\" data-id=\"256b7d99\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3efbac6c elementor-widget elementor-widget-text-editor\" data-id=\"3efbac6c\" 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 data-start=\"929\" data-end=\"955\">Classification depends on the product\u2019s primary mode of action, intended use, and whether the medicinal or device component plays the principal therapeutic role.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1004\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"5\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1004\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Is clinical evaluation required for EU combination products? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1004\" class=\"elementor-element elementor-element-55b5248 e-con-full e-flex e-con e-child\" data-id=\"55b5248\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-335453c elementor-widget elementor-widget-text-editor\" data-id=\"335453c\" 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 data-start=\"1163\" data-end=\"1193\">Yes. Manufacturers must provide clinical evaluation data to demonstrate product safety, performance, and compliance with EU MDR requirements.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<script type=\"application\/ld+json\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"What are combination products under EU regulations?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Combination products are products that combine a medical device with a medicinal product, biologic, or drug component to achieve their intended medical purpose.\"}},{\"@type\":\"Question\",\"name\":\"Which EU regulation applies to combination products?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Combination products in Europe are primarily regulated under the EU Medical Device Regulation (EU MDR 2017\\\/745) and may also involve pharmaceutical regulatory requirements depending on the product type.\"}},{\"@type\":\"Question\",\"name\":\"What are examples of medical device combination products?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Common examples include:Drug-eluting stentsPrefilled syringesInsulin pensInhalersTransdermal delivery systems\"}},{\"@type\":\"Question\",\"name\":\"How are combination products classified in the EU?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Classification depends on the product\\u2019s primary mode of action, intended use, and whether the medicinal or device component plays the principal therapeutic role.\"}},{\"@type\":\"Question\",\"name\":\"Is clinical evaluation required for EU combination products?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Yes. Manufacturers must provide clinical evaluation data to demonstrate product safety, performance, and compliance with EU MDR requirements.\"}}]}<\/script>\n\t\t\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>Welcome to a guide simplifying regulatory rules for Medical Device Combination Products. These unique hybrids revolutionize healthcare, but sticking to regulations is crucial.\u00a0Imagine devices and meds teaming up for better treatments. But getting these innovations out there isn\u2019t simple. Regulations ensure they\u2019re safe and effective. Navigating this means understanding evolving rules. In this article, we\u2019ll [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":6510,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[55],"tags":[],"class_list":["post-6509","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\/6509","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=6509"}],"version-history":[{"count":0,"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/posts\/6509\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/media\/6510"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/media?parent=6509"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/categories?post=6509"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/tags?post=6509"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}