{"id":18431,"date":"2026-07-28T16:14:22","date_gmt":"2026-07-28T10:44:22","guid":{"rendered":"https:\/\/operonstrategist.com\/?p=18431"},"modified":"2026-07-28T16:21:42","modified_gmt":"2026-07-28T10:51:42","slug":"uk-responsible-person-for-medical-devices-ivds","status":"publish","type":"post","link":"https:\/\/operonstrategist.com\/gb-en\/uk-responsible-person-for-medical-devices-ivds\/","title":{"rendered":"UK Responsible Person [UKRP] for Medical Devices &#038; IVDs (MHRA Compliance Guide)"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"18431\" class=\"elementor elementor-18431\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6a95f8d7 e-flex e-con-boxed e-con e-parent\" data-id=\"6a95f8d7\" 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-7d4d9eb4 elementor-widget elementor-widget-heading\" data-id=\"7d4d9eb4\" 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\">UK Responsible Person [UKRP] for Medical Devices &#038; IVDs (MHRA Compliance Guide)<\/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-57c23297 e-flex e-con-boxed e-con e-parent\" data-id=\"57c23297\" 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-d27a316 e-con-full e-flex e-con e-child\" data-id=\"d27a316\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-586595ea elementor-widget elementor-widget-heading\" data-id=\"586595ea\" 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:\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-752cb61e elementor-widget elementor-widget-text-editor\" data-id=\"752cb61e\" 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 regulatory shift following Brexit, foreign medical device and IVD (in vitro diagnostic) manufacturers looking to enter the UK market must appoint a UK Responsible Person (UKRP) as mandated by the UK MDR 2002 (amended in 2019). This role is crucial for ensuring compliance with the Medicines and Healthcare Products Regulatory Agency (MHRA) and smooth market access to Great Britain.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5bd221e5 elementor-widget elementor-widget-heading\" data-id=\"5bd221e5\" 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\">What Is a UK Responsible Person (UKRP)?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e5fdaa5 elementor-widget elementor-widget-text-editor\" data-id=\"e5fdaa5\" 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;\">A UK Responsible Person functions as the UK counterpart of the EU Authorized Representative. Any non-UK manufacturer placing medical devices or IVDs on the UK market is required to designate a UKRP. The UKRP acts on behalf of the manufacturer to ensure regulatory compliance with the UK MDR.<\/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-78f93738 e-con-full e-flex e-con e-child\" data-id=\"78f93738\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-5a324966 e-con-full e-flex e-con e-child\" data-id=\"5a324966\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-66b59ac5 elementor-widget elementor-widget-heading\" data-id=\"66b59ac5\" 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\">Let's Connect! Your Queries, Our Expertise!\n<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-17069aa9 elementor-widget elementor-widget-wpforms\" data-id=\"17069aa9\" 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\/18431\" data-token=\"acb91328aa717bbfc565447aa10cd47d\" data-token-time=\"1785633948\"><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\">\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 Name Phone<\/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_1-container\" class=\"wpforms-field wpforms-field-name\" data-field-type=\"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-type=\"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-type=\"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-type=\"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\/18431\"><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-4458aa22 e-con-full e-flex e-con e-parent\" data-id=\"4458aa22\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-64e3122 elementor-widget elementor-widget-text-editor\" data-id=\"64e3122\" 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 appointment must be documented through a signed agreement between the manufacturer and the UKRP, clearly indicating both parties\u2019 names, addresses, and roles. The UKRP assumes key responsibilities, including MHRA registration, compliance support, and post-market surveillance activities.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7425e9a elementor-widget elementor-widget-heading\" data-id=\"7425e9a\" 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 Is Appointing a UKRP Mandatory?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b5e972d elementor-widget elementor-widget-text-editor\" data-id=\"b5e972d\" 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;\">Post-Brexit, the UK regulatory landscape has diverged from the EU MDR. Foreign manufacturers must now:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Appoint a UKRP<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Ensure the product has a UKCA marking (or CE marking where accepted temporarily)<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Register with the MHRA before placing the product on the UK market<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">This regulatory step helps MHRA maintain oversight on devices sold within the country and ensures they meet safety and performance standards.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e04b2a5 elementor-widget elementor-widget-heading\" data-id=\"e04b2a5\" 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\">Key Responsibilities of a UK Responsible Person\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7dec4e0 elementor-widget elementor-widget-text-editor\" data-id=\"7dec4e0\" 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 UKRP plays a strategic compliance role, including:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Verifying device classification and conformity assessment<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Ensuring the manufacturer holds valid technical documentation and Declaration of Conformity (DoC)<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Maintaining accessible copies of documentation for MHRA inspection<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Coordinating with MHRA in case of device recalls or safety actions<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Supporting the manufacturer in Post-Market Surveillance (PMS) and Vigilance reporting<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Assisting with the registration of devices with the MHRA<\/span><\/li><li aria-level=\"1\"><span style=\"font-weight: 400;\">Notifying MHRA and terminating representation if the manufacturer breaches compliance<\/span><span style=\"font-weight: 400;\"><br \/><\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3a10946 elementor-widget elementor-widget-heading\" data-id=\"3a10946\" 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\">UKRP Appointment and MHRA Registration Timelines\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9d0d702 elementor-widget elementor-widget-text-editor\" data-id=\"9d0d702\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<table><tbody><tr><td><p><b>Activity<\/b><\/p><\/td><td><p><b>Timeframe<\/b><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">UKRP Appointment<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Usually 3-4 working days<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">MHRA Device Registration<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Usually 4-6 working days<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">FSC &amp; Apostille<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Usually 6-8 working days<\/span><\/p><\/td><\/tr><\/tbody><\/table>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-44348a6 elementor-widget elementor-widget-heading\" data-id=\"44348a6\" 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\">Benefits of Collaborating with a Trusted UKRP Partner<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-16aa96d elementor-widget elementor-widget-text-editor\" data-id=\"16aa96d\" 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;\">Appointing the right UKRP is not just a formality\u2014it directly affects your ability to enter and thrive in the UK medical device market. A knowledgeable UKRP offers:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Expert guidance on <\/span><span style=\"font-weight: 400;\">MHRA requirements<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">End-to-end support for compliance documentation<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Access to testing labs for biocompatibility and clinical evaluations<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Coordination with notified or certification bodies for UKCA marking<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Risk-benefit analysis and CAPA support<\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-767c2fe elementor-widget elementor-widget-heading\" data-id=\"767c2fe\" 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\">Partner with Operon Strategist for UKRP and MHRA Compliance\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b8c496d elementor-widget elementor-widget-text-editor\" data-id=\"b8c496d\" 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><a href=\"https:\/\/operonstrategist.com\/gb-en\"><span style=\"font-weight: 400;\">Operon Strategist<\/span><\/a><span style=\"font-weight: 400;\"> offers comprehensive UKRP services tailored for medical device and IVD manufacturers aiming to enter the UK market. With years of regulatory expertise and a global presence, we support manufacturers not just with MHRA registration, but also with:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Technical Documentation for <\/span><a href=\"https:\/\/operonstrategist.com\/gb-en\/elevateplus\/ukca-marking\/\"><span style=\"font-weight: 400;\">UKCA marking<\/span><\/a><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Risk Management and Clinical Evaluation<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/operonstrategist.com\/gb-en\/elevateplus\/quality-management-system-qms\/\"><span style=\"font-weight: 400;\">ISO 13485<\/span><\/a><span style=\"font-weight: 400;\"> QMS Implementation<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">End-to-end Regulatory Consulting<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">Stay compliant. Enter the UK market with confidence.<\/span><span style=\"font-weight: 400;\"><br \/><\/span><span style=\"font-weight: 400;\">Partner with<\/span><a href=\"https:\/\/operonstrategist.com\/gb-en\/contact-us\/\"> <span style=\"font-weight: 400;\">Operon Strategist<\/span><\/a><span style=\"font-weight: 400;\"> \u2013 Your Regulatory Ally for UKRP &amp; Beyond!<\/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-4ebed680 e-con-full e-flex e-con e-child\" data-id=\"4ebed680\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-39b9f79b elementor-widget elementor-widget-heading\" data-id=\"39b9f79b\" 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-6eee400 elementor-widget elementor-widget-n-accordion\" data-id=\"6eee400\" 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-1160\" 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-1160\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Who is 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-1160\" class=\"elementor-element elementor-element-3c6608d8 e-con-full e-flex e-con e-child\" data-id=\"3c6608d8\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-15bd88f4 elementor-widget elementor-widget-text-editor\" data-id=\"15bd88f4\" 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>A UK Responsible Person (UKRP) is a legal entity established in the United Kingdom that acts on behalf of a medical device or in vitro diagnostic (IVD) manufacturer located outside the UK. The UKRP carries out specific regulatory responsibilities under the UK Medical Devices Regulations 2002 (as amended) to support compliance before devices are placed on the Great Britain market.<\/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-1161\" 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-1161\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> When is a UK Responsible Person required? <\/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-1161\" class=\"elementor-element elementor-element-40aadef e-con-full e-flex e-con e-child\" data-id=\"40aadef\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2ec7aaa3 elementor-widget elementor-widget-text-editor\" data-id=\"2ec7aaa3\" 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>A UK Responsible Person is generally required when a manufacturer based outside the UK wishes to place medical devices or IVDs on the Great Britain market. The UKRP serves as the primary regulatory contact with the MHRA and helps ensure that the manufacturer&#8217;s devices meet the applicable UK regulatory 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\t<details id=\"e-n-accordion-item-1162\" 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-1162\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What are the responsibilities of a UK Responsible Person? <\/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-1162\" class=\"elementor-element elementor-element-50a80d44 e-con-full e-flex e-con e-child\" data-id=\"50a80d44\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2d42e262 elementor-widget elementor-widget-text-editor\" data-id=\"2d42e262\" 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>A UK Responsible Person is responsible for verifying that the manufacturer&#8217;s technical documentation and Declaration of Conformity have been prepared, maintaining access to regulatory documentation, registering eligible devices with the MHRA, cooperating with the MHRA during inspections and investigations, facilitating post-market surveillance activities, and supporting field safety corrective actions where required.<\/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-1163\" 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-1163\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What documents are required for UKRP and MHRA 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-1163\" class=\"elementor-element elementor-element-7a308208 e-con-full e-flex e-con e-child\" data-id=\"7a308208\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-29f975c5 elementor-widget elementor-widget-text-editor\" data-id=\"29f975c5\" 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>Manufacturers generally need technical documentation, a Declaration of Conformity, ISO 13485 certification where applicable, ISO 14971 risk management documentation, clinical or performance evaluation documentation, labeling, Instructions for Use (IFU), post-market surveillance procedures, vigilance documentation, and manufacturer information to support MHRA registration and UKRP responsibilities.<\/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\":\"Who is a UK Responsible Person (UKRP)?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"A UK Responsible Person (UKRP) is a legal entity established in the United Kingdom that acts on behalf of a medical device or in vitro diagnostic (IVD) manufacturer located outside the UK. 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This role is crucial for ensuring compliance with the Medicines and Healthcare Products Regulatory Agency [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":21571,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[99],"tags":[],"class_list":["post-18431","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-mhra"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/posts\/18431","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=18431"}],"version-history":[{"count":7,"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/posts\/18431\/revisions"}],"predecessor-version":[{"id":21592,"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/posts\/18431\/revisions\/21592"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/media\/21571"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/media?parent=18431"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/categories?post=18431"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/tags?post=18431"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}