{"id":6825,"date":"2026-06-08T18:21:15","date_gmt":"2026-06-08T12:51:15","guid":{"rendered":"https:\/\/operonstrategist.com\/?p=6825"},"modified":"2026-06-08T18:21:15","modified_gmt":"2026-06-08T12:51:15","slug":"navigating-the-european-nb-opinion-process-for-drug-device-combination-products","status":"publish","type":"post","link":"https:\/\/operonstrategist.com\/gb-en\/navigating-the-european-nb-opinion-process-for-drug-device-combination-products\/","title":{"rendered":"Navigating European NB Opinion for Drug-Device Combination Products (A Comprehensive Guide)"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"6825\" class=\"elementor elementor-6825\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4485ac94 e-flex e-con-boxed e-con e-parent\" data-id=\"4485ac94\" 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-2cf56a9d elementor-widget elementor-widget-heading\" data-id=\"2cf56a9d\" 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 European NB Opinion for Drug-Device Combination Products (A Comprehensive Guide)<\/h2>\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-1a120079 e-flex e-con-boxed e-con e-parent\" data-id=\"1a120079\" 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-6b0365f8 e-con-full e-flex e-con e-child\" data-id=\"6b0365f8\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3bd48078 elementor-widget elementor-widget-heading\" data-id=\"3bd48078\" 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\">An Overview:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-488b81cc elementor-widget elementor-widget-text-editor\" data-id=\"488b81cc\" 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;\">In the dynamic realm of healthcare innovation, the convergence of pharmaceuticals and medical devices has led to the development of groundbreaking combination products. However, ensuring the safety and efficacy of these products requires navigating a complex regulatory landscape. For those seeking to introduce drug-device combination products to the European market, obtaining a Notified Body (NB) opinion is a crucial step.\u00a0\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">In this blog post, we\u2019ll explore the process flow for acquiring a European NB opinion for drug device combination products and the key considerations at each stage.\u00a0<\/span><\/p><p><i><span style=\"font-weight: 400;\">You can also check our service page on the <\/span><\/i><a href=\"https:\/\/operonstrategist.com\/elevateplus\/drug-device-combination-product-documentation\/\"><i><span style=\"font-weight: 400;\">drug-device combination products<\/span><\/i><\/a><i><span style=\"font-weight: 400;\">\u00a0for more details.<\/span><\/i><\/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-3a5f085b e-con-full e-flex e-con e-child\" data-id=\"3a5f085b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-614a5ff4 e-con-full e-flex e-con e-child\" data-id=\"614a5ff4\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5f8cb933 elementor-widget elementor-widget-heading\" data-id=\"5f8cb933\" 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\">Looking for a Medical Device Regulatory Consultant?\n<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-59a459cf elementor-widget elementor-widget-wpforms\" data-id=\"59a459cf\" 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=\"\/gb-en\/wp-json\/wp\/v2\/posts\/6825\" data-token=\"08115cc9be9ad5588cc368d2a2d40326\" data-token-time=\"1781372148\"><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*\" 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>\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-recaptcha-container wpforms-is-recaptcha wpforms-is-recaptcha-type-v3\" ><input type=\"hidden\" name=\"wpforms[recaptcha]\" value=\"\"><\/div><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\/gb-en\/wp-json\/wp\/v2\/posts\/6825\"><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-312682cc e-flex e-con-boxed e-con e-parent\" data-id=\"312682cc\" 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-e8ec0a9 elementor-widget elementor-widget-heading\" data-id=\"e8ec0a9\" 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\">Understanding the Regulatory Context\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3c584943 elementor-widget elementor-widget-text-editor\" data-id=\"3c584943\" 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;\">Before diving into the specifics of the process, it\u2019s essential to understand the regulatory context governing drug-device combination products in Europe. These products are subject to both the Medical Device Regulation (MDR) and the Medicinal Products Regulation (MPR), which necessitate adherence to stringent standards for safety, efficacy, and quality.\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5871c85 elementor-widget elementor-widget-heading\" data-id=\"5871c85\" 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\">Initial Assessment and Classification\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e316a8d elementor-widget elementor-widget-text-editor\" data-id=\"e316a8d\" 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 journey begins with a comprehensive initial assessment to determine the classification of the combination product. Factors such as its primary mode of action, intended use, and associated risks play a crucial role in classification. This step sets the stage for identifying the applicable regulatory requirements and the level of scrutiny during the evaluation process.\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c708ca5 elementor-widget elementor-widget-heading\" data-id=\"c708ca5\" 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\">Design and Development\n<\/h2>\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-5e452c1f e-con-full e-flex e-con e-child\" data-id=\"5e452c1f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f3506a6 elementor-widget elementor-widget-text-editor\" data-id=\"f3506a6\" 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;\">Once the product is classified, the design and development phase ensues. Collaboration between pharmaceutical and medical device experts is essential to ensure the seamless integration of drug and device components. Rigorous design controls and <\/span><a href=\"https:\/\/operonstrategist.com\/elevateplus\/quality-management-system-qms\/\"><span style=\"font-weight: 400;\">quality management systems<\/span><\/a><span style=\"font-weight: 400;\"> are employed to uphold safety, efficacy, and quality standards throughout the development process.\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-63481d6 elementor-widget elementor-widget-heading\" data-id=\"63481d6\" 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\">Compilation of Technical Documentation<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-886f630 elementor-widget elementor-widget-text-editor\" data-id=\"886f630\" 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;\">Central to the regulatory submission is the compilation of comprehensive technical documentation. This dossier should encompass all relevant data on device design, pharmaceutical formulation, manufacturing processes, risk management, and clinical evidence. Ensuring the completeness and accuracy of this documentation is paramount to facilitate a thorough evaluation by the NB.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1ec72be elementor-widget elementor-widget-heading\" data-id=\"1ec72be\" 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\">Submission to Notified Body\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ce19130 elementor-widget elementor-widget-text-editor\" data-id=\"ce19130\" 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;\">With the technical documentation finalized, the submission is made to a designated Notified Body. Notified Bodies are independent organizations authorized by EU member states to assess the conformity of medical devices and combination products with regulatory requirements. The submission initiates the evaluation process, where experienced assessors meticulously review the documentation.\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-189805d elementor-widget elementor-widget-heading\" data-id=\"189805d\" 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\">Evaluation and Assessment\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bb1c9c2 elementor-widget elementor-widget-text-editor\" data-id=\"bb1c9c2\" 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;\">During the evaluation phase, the Notified Body assesses the submitted documentation to verify compliance with regulatory requirements and standards. This involves scrutinizing all aspects of the product, including design, manufacturing processes, risk management measures, and clinical data. Any deficiencies or gaps identified during the evaluation must be addressed promptly to progress through the approval process. <\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-210b98f elementor-widget elementor-widget-heading\" data-id=\"210b98f\" 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\">Issuance of NB Opinion\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3c45d6b elementor-widget elementor-widget-text-editor\" data-id=\"3c45d6b\" 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;\">Upon successful completion of the evaluation process, the Notified Body issues its opinion regarding the conformity of the combination product with regulatory requirements. This opinion serves as a pivotal milestone, indicating that the product meets the necessary standards for market approval within the EU. It provides assurance to regulators, healthcare professionals, and patients regarding the safety and performance of the product.\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2f2a4e1 elementor-widget elementor-widget-heading\" data-id=\"2f2a4e1\" 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\">Conclusion\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-32223aa elementor-widget elementor-widget-text-editor\" data-id=\"32223aa\" 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;\">Navigating the process for obtaining a European NB opinion for drug-device combination products requires meticulous planning, interdisciplinary collaboration, and adherence to stringent regulatory requirements. By understanding the process flow outlined above and addressing key considerations at each stage, developers can streamline the approval process and bring innovative therapies to patients in need. Despite the challenges posed by the regulatory landscape, obtaining a European NB opinion represents a significant milestone on the path to market access and ultimately improving patient outcomes.\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-32d16c8 elementor-widget elementor-widget-heading\" data-id=\"32d16c8\" 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\">Operon Strategist's Expertise in Drug-Device Combination Product Regulation\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-11be7cf elementor-widget elementor-widget-text-editor\" data-id=\"11be7cf\" 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 specializes in guiding clients through the intricate regulatory landscape surrounding <\/span><span style=\"font-weight: 400;\">drug-device combination products<\/span><span style=\"font-weight: 400;\">. Our dedicated team of experts is committed to providing comprehensive support, from initial assessment to securing a European <a href=\"https:\/\/operonstrategist.com\/notified-bodies-for-medical-devices\/\">Notified Body (NB)<\/a> opinion. Ready to streamline your path to market approval? <\/span><a href=\"https:\/\/operonstrategist.com\/contact-us\/\"><span style=\"font-weight: 400;\">Contact Operon Strategist<\/span><\/a><span style=\"font-weight: 400;\"> today and unlock success in bringing your innovative combination product to patients in need. Let\u2019s navigate the regulatory maze together and pave the way for success! <\/span><\/p>\t\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>An Overview: In the dynamic realm of healthcare innovation, the convergence of pharmaceuticals and medical devices has led to the development of groundbreaking combination products. However, ensuring the safety and efficacy of these products requires navigating a complex regulatory landscape. For those seeking to introduce drug-device combination products to the European market, obtaining a Notified [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":10818,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[55],"tags":[],"class_list":["post-6825","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulatory"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/posts\/6825","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/comments?post=6825"}],"version-history":[{"count":5,"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/posts\/6825\/revisions"}],"predecessor-version":[{"id":10823,"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/posts\/6825\/revisions\/10823"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/media\/10818"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/media?parent=6825"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/categories?post=6825"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/tags?post=6825"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}