{"id":6448,"date":"2026-05-20T15:16:16","date_gmt":"2026-05-20T09:46:16","guid":{"rendered":"https:\/\/operonstrategist.com\/?p=6448"},"modified":"2026-05-20T15:16:16","modified_gmt":"2026-05-20T09:46:16","slug":"guide-to-mhra-medical-device-registration","status":"publish","type":"post","link":"https:\/\/operonstrategist.com\/eg-en\/guide-to-mhra-medical-device-registration\/","title":{"rendered":"MHRA Medical Device Registration: Complete Guide to Steps, Cost &#038; UK Approval"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"6448\" class=\"elementor elementor-6448\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1e878dc8 e-flex e-con-boxed e-con e-parent\" data-id=\"1e878dc8\" 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-3bfa7c20 e-con-full e-flex e-con e-child\" data-id=\"3bfa7c20\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2c660a60 elementor-widget elementor-widget-heading\" data-id=\"2c660a60\" 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\">Introduction to MHRA Medical Device Registration\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-194c055 elementor-widget elementor-widget-text-editor\" data-id=\"194c055\" 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;\">Entering the UK market requires more than just a quality product\u2014it requires strict regulatory compliance. MHRA medical device registration is a mandatory step for any manufacturer who wants to sell medical devices or IVDs in Great Britain.<\/span><\/p><p><span style=\"font-weight: 400;\">The Medicines and Healthcare Products Regulatory Agency (MHRA) is responsible for regulating medical devices in the UK. Its role is to ensure that all products placed on the market meet the required standards for safety, quality, and performance.<\/span><\/p><p><span style=\"font-weight: 400;\">Without MHRA registration, a medical device cannot be legally marketed in the UK. Therefore, understanding the registration process is essential for a smooth and successful market entry.<br \/><\/span><\/p><p><span style=\"font-weight: 400;\">Explore our comprehensive guide to <\/span><a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/uk-ca-marking\/\"><span style=\"font-weight: 400;\">UKCA marking for medical devices<\/span><\/a><span style=\"font-weight: 400;\"> on our service page, and let Operon Strategist expertly guide you through the MHRA<\/span><span style=\"font-weight: 400;\"> registration process for seamless market entry in the UK.<\/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-3fbd9ad5 e-con-full e-flex e-con e-child\" data-id=\"3fbd9ad5\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-54fe92b5 e-con-full e-flex e-con e-child\" data-id=\"54fe92b5\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-101670ac elementor-widget elementor-widget-heading\" data-id=\"101670ac\" 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-38d1dc1b elementor-widget elementor-widget-wpforms\" data-id=\"38d1dc1b\" 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\/6448\" 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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\/6448\"><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-77d13a37 e-flex e-con-boxed e-con e-parent\" data-id=\"77d13a37\" 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-636b32a7 elementor-widget elementor-widget-heading\" data-id=\"636b32a7\" 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 UK MHRA Medical and IVD Device Step-by-Step Approval Process<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6fa32cdc elementor-widget elementor-widget-text-editor\" data-id=\"6fa32cdc\" 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;\">Understanding the process step by step helps avoid delays and ensures compliance.<\/span><\/p><p><strong>1. Device Classification<\/strong><\/p><p><span style=\"font-weight: 400;\">The first step is to determine the correct classification of your device.<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Medical Devices: Class I, IIa, IIb, III<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">IVDs: Class A, B, C, D<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">Accurate classification is critical, as it determines the regulatory pathway and documentation requirements.<\/span><\/p><p><strong>2. Conformity Assessment and QMS Implementation<\/strong><\/p><p><span style=\"font-weight: 400;\">Based on the classification, manufacturers must follow the appropriate conformity assessment route.<\/span><\/p><p><span style=\"font-weight: 400;\">In most cases, implementing a <\/span><a href=\"https:\/\/operonstrategist.com\/services\/turnkey-project\/quality-management-system\/\"><span style=\"font-weight: 400;\">Quality Management System<\/span><\/a><span style=\"font-weight: 400;\"> (QMS) aligned with <\/span><a href=\"https:\/\/operonstrategist.com\/services\/turnkey-project\/quality-management-system\/iso-13485\/\"><span style=\"font-weight: 400;\">ISO 13485<\/span><\/a><span style=\"font-weight: 400;\"> is required. This ensures consistent quality and regulatory compliance.<\/span><\/p><p><strong>3. Technical Documentation Preparation<\/strong><\/p><p><span style=\"font-weight: 400;\">A comprehensive technical file must be prepared, including:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Device description and intended use<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Risk management documentation<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Clinical or performance evaluation<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Labeling and Instructions for Use (IFU)<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">Well-prepared documentation plays a key role in avoiding regulatory queries and delays.<\/span><\/p><p><strong>4. Appointment of UK Responsible Person (UKRP)<\/strong><\/p><p><span style=\"font-weight: 400;\">Non-UK manufacturers must appoint a UKRP.<\/span><\/p><p><span style=\"font-weight: 400;\">The UKRP is responsible for:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Registering the device with MHRA<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Acting as a point of contact with regulators<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Maintaining regulatory documentation<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">Choosing an experienced UKRP can significantly improve the efficiency of the process.<\/span><\/p><p><strong>5. Declaration of Conformity and UKCA Marking<\/strong><\/p><p><span style=\"font-weight: 400;\">Once compliance requirements are met, manufacturers must prepare a Declaration of Conformity and affix the <\/span><a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/uk-ca-marking\/\"><span style=\"font-weight: 400;\">UKCA marking<\/span><\/a><span style=\"font-weight: 400;\"> to the device.<\/span><\/p><p><span style=\"font-weight: 400;\">This step confirms that the product meets UK regulatory requirements.<\/span><\/p><p><strong>6. Device Registration via DORS<\/strong><\/p><p><span style=\"font-weight: 400;\">The device is registered through the MHRA Device Online Registration System (DORS).<\/span><\/p><p><span style=\"font-weight: 400;\">The application includes:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Manufacturer details<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Device details<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Applicable registration fee<\/span><\/li><\/ul><p><strong>7. MHRA Review and Approval<\/strong><\/p><p><span style=\"font-weight: 400;\">After submission, MHRA reviews the application.<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Standard review time: approximately 5 working days<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Additional information may be requested if required<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">Once approved, MHRA issues a registration confirmation, allowing the device to be legally marketed in the UK.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d32d221 elementor-widget elementor-widget-heading\" data-id=\"d32d221\" 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\">Who Needs MHRA Medical Device Registration?\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-399ea228 e-con-full e-flex e-con e-child\" data-id=\"399ea228\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a8009cd elementor-widget elementor-widget-text-editor\" data-id=\"a8009cd\" 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;\">MHRA registration is required for:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Medical device manufacturers<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/operonstrategist.com\/in-vitro-diagnostic-medical-device-regulation\/\"><span style=\"font-weight: 400;\">In vitro diagnostic<\/span><\/a><span style=\"font-weight: 400;\"> (IVD) manufacturers<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Non-UK manufacturers exporting to the UK<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Importers and distributors placing devices on the UK market<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">For manufacturers located outside the UK, appointing a UK Responsible Person (UKRP) is mandatory. The UKRP acts as a local representative and handles communication with the MHRA.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a79dbac elementor-widget elementor-widget-heading\" data-id=\"a79dbac\" 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\">Cost of MHRA Medical Device Registration<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c9a95be elementor-widget elementor-widget-text-editor\" data-id=\"c9a95be\" 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;\">Understanding the cost structure is important for proper planning.<\/span><\/p><p><strong>Registration Fee<\/strong><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">MHRA charges \u00a3240 per registration<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Up to 100 devices can be included in a single submission if grouped correctly<\/span><\/li><\/ul><h4><span style=\"font-weight: 400;\">Additional Costs<\/span><\/h4><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">UK Responsible Person (UKRP) services<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/operonstrategist.com\/services\/turnkey-project\/quality-management-system\/iso-13485\/\"><span style=\"font-weight: 400;\">ISO 13485<\/span><\/a> <a href=\"https:\/\/operonstrategist.com\/services\/turnkey-project\/quality-management-system\/\"><span style=\"font-weight: 400;\">QMS<\/span><\/a><span style=\"font-weight: 400;\"> implementation<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">UK Approved Body certification (if applicable)<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Technical documentation preparation<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">Proper planning can help control costs and avoid unnecessary expenses.<\/span><\/p><p><strong>Timeline for MHRA Registration<\/strong><\/p><p><span style=\"font-weight: 400;\">Standard approval timeline: around 5 working days<\/span><span style=\"font-weight: 400;\"><br \/><\/span><span style=\"font-weight: 400;\">Delays may occur if:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Documentation is incomplete<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Additional information is required<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">Submitting a complete and accurate application helps ensure faster approval.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-05465fc elementor-widget elementor-widget-heading\" data-id=\"05465fc\" 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\">Why Choose Operon Strategist for MHRA Medical Device Registration?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2209379 elementor-widget elementor-widget-text-editor\" data-id=\"2209379\" 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 provides end-to-end support for MHRA medical device registration, helping manufacturers achieve faster and smoother approvals.<\/span><\/p><p><span style=\"font-weight: 400;\">Our services include:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Device classification and regulatory strategy<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">UK Responsible Person (UKRP) support<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Technical documentation preparation<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/uk-ca-marking\/\"><span style=\"font-weight: 400;\">UKCA marking<\/span><\/a><span style=\"font-weight: 400;\"> compliance<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Complete registration support<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">We also assist with <\/span><a href=\"https:\/\/operonstrategist.com\/services\/turnkey-project\/quality-management-system\/iso-13485\/\"><span style=\"font-weight: 400;\">ISO 13485<\/span><\/a><span style=\"font-weight: 400;\">, <\/span><a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/ce-marking\/\"><span style=\"font-weight: 400;\">CE Marking<\/span><\/a><span style=\"font-weight: 400;\">, <\/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;\">, and global regulatory approvals, ensuring a seamless compliance journey.<\/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-48893c6 e-con-full e-flex e-con e-child\" data-id=\"48893c6\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2ab018ec elementor-widget elementor-widget-heading\" data-id=\"2ab018ec\" 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-732c0526 elementor-widget elementor-widget-n-accordion\" data-id=\"732c0526\" 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-1930\" 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-1930\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What is MHRA medical device registration? <\/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-1930\" class=\"elementor-element elementor-element-7a17b7ff e-con-full e-flex e-con e-child\" data-id=\"7a17b7ff\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-10128983 elementor-widget elementor-widget-text-editor\" data-id=\"10128983\" 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;\">MHRA medical device registration is the mandatory process of registering medical devices and IVDs with the UK regulatory authority before they can be legally sold in Great Britain.<\/span><\/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-1931\" 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-1931\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Is MHRA registration required for all medical devices? <\/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-1931\" class=\"elementor-element elementor-element-6bc45ca9 e-con-full e-flex e-con e-child\" data-id=\"6bc45ca9\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2487e15c elementor-widget elementor-widget-text-editor\" data-id=\"2487e15c\" 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;\">Yes, all medical devices and IVDs must be registered with MHRA before being placed on the UK market.<\/span><\/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-1932\" 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-1932\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Who needs a UK Responsible Person (UKRP)? <\/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-1932\" class=\"elementor-element elementor-element-22412c81 e-con-full e-flex e-con e-child\" data-id=\"22412c81\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4bc2822c elementor-widget elementor-widget-text-editor\" data-id=\"4bc2822c\" 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;\">Non-UK manufacturers must appoint a UK Responsible Person (UKRP) to handle device registration and communication with the MHRA.<\/span><\/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-1933\" 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-1933\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What is the cost of MHRA medical device registration? <\/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-1933\" class=\"elementor-element elementor-element-6900b172 e-con-full e-flex e-con e-child\" data-id=\"6900b172\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-15241abc elementor-widget elementor-widget-text-editor\" data-id=\"15241abc\" 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 MHRA charges a standard fee of \u00a3240 per registration, which can cover multiple devices if they are grouped correctly.<\/span><\/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-1934\" 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-1934\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> How long does MHRA registration take? <\/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-1934\" class=\"elementor-element elementor-element-b4abd72 e-con-full e-flex e-con e-child\" data-id=\"b4abd72\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-37bf960 elementor-widget elementor-widget-text-editor\" data-id=\"37bf960\" 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 MHRA typically reviews applications within 5 working days, although timelines may extend if additional information is required.<\/span><\/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 is MHRA medical device registration?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"MHRA medical device registration is the mandatory process of registering medical devices and IVDs with the UK regulatory authority before they can be legally sold in Great Britain.\"}},{\"@type\":\"Question\",\"name\":\"Is MHRA registration required for all medical devices?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Yes, all medical devices and IVDs must be registered with MHRA before being placed on the UK market.\"}},{\"@type\":\"Question\",\"name\":\"Who needs a UK Responsible Person (UKRP)?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Non-UK manufacturers must appoint a UK Responsible Person (UKRP) to handle device registration and communication with the MHRA.\"}},{\"@type\":\"Question\",\"name\":\"What is the cost of MHRA medical device registration?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"The MHRA charges a standard fee of \\u00a3240 per registration, which can cover multiple devices if they are grouped correctly.\"}},{\"@type\":\"Question\",\"name\":\"How long does MHRA registration take?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"The MHRA typically reviews applications within 5 working days, although timelines may extend if additional information is required.\"}}]}<\/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>Introduction to MHRA Medical Device Registration Entering the UK market requires more than just a quality product\u2014it requires strict regulatory compliance. MHRA medical device registration is a mandatory step for any manufacturer who wants to sell medical devices or IVDs in Great Britain. The Medicines and Healthcare Products Regulatory Agency (MHRA) is responsible for regulating [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":6477,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[55],"tags":[],"class_list":["post-6448","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\/6448","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=6448"}],"version-history":[{"count":0,"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/posts\/6448\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/media\/6477"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/media?parent=6448"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/categories?post=6448"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/tags?post=6448"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}