{"id":3258,"date":"2025-05-22T11:24:43","date_gmt":"2025-05-22T11:24:43","guid":{"rendered":"https:\/\/operonstrategist.com\/en-gb\/?p=3258"},"modified":"2025-05-22T11:55:55","modified_gmt":"2025-05-22T11:55:55","slug":"uk-responsible-person-for-medical-devices-ivds","status":"publish","type":"post","link":"https:\/\/operonstrategist.com\/en-gb\/uk-responsible-person-for-medical-devices-ivds\/","title":{"rendered":"UK Responsible Person For Medical Devices &amp; IVDs!"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"3258\" class=\"elementor elementor-3258\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-b73920d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"b73920d\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-7905ec9\" data-id=\"7905ec9\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-f3c7c85 elementor-widget elementor-widget-heading\" data-id=\"f3c7c85\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\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>\n\t\t\t\t<div class=\"elementor-element elementor-element-b267b60 elementor-widget elementor-widget-text-editor\" data-id=\"b267b60\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\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><p><em><strong>Also, read our service page on: <a href=\"https:\/\/operonstrategist.com\/en-gb\/services\/regulatory-approvals\/ukca-marking\/\">UKCA marking for medical devices\u00a0<\/a><\/strong><\/em><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-98d4fcd elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"98d4fcd\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-45fa3b8\" data-id=\"45fa3b8\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-9f165da elementor-widget elementor-widget-heading\" data-id=\"9f165da\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\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>\n\t\t\t\t<div class=\"elementor-element elementor-element-800f788 elementor-widget elementor-widget-text-editor\" data-id=\"800f788\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\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><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&#8217; 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>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-f3d8bd6\" data-id=\"f3d8bd6\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2ceaa2d elementor-widget elementor-widget-heading\" data-id=\"2ceaa2d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Let's Connect! 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<span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><select id=\"wpforms-2403-field_7\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][7]\" required=\"required\"><option value=\"Google\/Web Search\"  class=\"choice-1 depth-1\"  >Google\/Web Search<\/option><option value=\"Social Media\"  class=\"choice-2 depth-1\"  >Social Media<\/option><option value=\"Email Marketing\"  class=\"choice-3 depth-1\"  >Email Marketing<\/option><option value=\"Referred by colleague\"  class=\"choice-4 depth-1\"  >Referred by colleague<\/option><option value=\"Shows \/ Exhibition\"  class=\"choice-5 depth-1\"  >Shows \/ Exhibition<\/option><option value=\"Other\"  class=\"choice-6 depth-1\"  >Other<\/option><\/select><\/div><\/div><!-- .wpforms-field-container --><div class=\"wpforms-submit-container\" ><input type=\"hidden\" name=\"wpforms[id]\" value=\"2403\"><input type=\"hidden\" name=\"page_title\" value=\"\"><input type=\"hidden\" name=\"page_url\" value=\"https:\/\/operonstrategist.com\/en-gb\/wp-json\/wp\/v2\/posts\/3258\"><input type=\"hidden\" name=\"url_referer\" value=\"\"><button type=\"submit\" name=\"wpforms[submit]\" id=\"wpforms-submit-2403\" 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\/en-gb\/wp-content\/plugins\/wpforms-lite\/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\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-f71d419 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"f71d419\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-eace124\" data-id=\"eace124\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-81e3716 elementor-widget elementor-widget-heading\" data-id=\"81e3716\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Why Is Appointing a UKRP Mandatory?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-62d3d40 elementor-widget elementor-widget-text-editor\" data-id=\"62d3d40\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\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><span style=\"font-weight: 400;\"><br \/><\/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>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-da6ee1d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"da6ee1d\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-2535075\" data-id=\"2535075\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-b25ec7d elementor-widget elementor-widget-heading\" data-id=\"b25ec7d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\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>\n\t\t\t\t<div class=\"elementor-element elementor-element-76b43ad elementor-widget elementor-widget-text-editor\" data-id=\"76b43ad\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\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><\/ul><p><em><strong>Also read our blog page on: <a href=\"http:\/\/The Ultimate Guide to MHRA Medical Device Registration\" data-wplink-url-error=\"true\">The Ultimate Guide to MHRA Medical Device Registration<\/a><\/strong><\/em><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Notifying MHRA and terminating representation if the manufacturer breaches compliance<\/span><p>\u00a0<\/p><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-402acf9 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"402acf9\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-efe0ac8\" data-id=\"efe0ac8\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-be25f31 elementor-widget elementor-widget-heading\" data-id=\"be25f31\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\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>\n\t\t\t\t<div class=\"elementor-element elementor-element-d6965d3 elementor-widget elementor-widget-text-editor\" data-id=\"d6965d3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\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>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-8bf50d5 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"8bf50d5\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-e20bab7\" data-id=\"e20bab7\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-a36d429 elementor-widget elementor-widget-heading\" data-id=\"a36d429\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Benefits of Collaborating with a Trusted UKRP Partner\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e102b18 elementor-widget elementor-widget-text-editor\" data-id=\"e102b18\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\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 <a href=\"https:\/\/operonstrategist.com\/en-gb\/ukca-marking-requirements-for-medical-devices\/\">MHRA requirements<\/a><\/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><span style=\"font-weight: 400;\"><br \/><\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-de9a985 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"de9a985\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-abfb0bb\" data-id=\"abfb0bb\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-078996e elementor-widget elementor-widget-heading\" data-id=\"078996e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Need Help Appointing Your UK Responsible Person or Registering With Mhra?<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6b93b98 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"6b93b98\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/operonstrategist.com\/en-gb\/contact-us\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Contact us now!<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-349692a elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"349692a\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-8b99bf7\" data-id=\"8b99bf7\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-54437ac elementor-widget elementor-widget-heading\" data-id=\"54437ac\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Partner with Operon Strategist for UKRP and MHRA Compliance<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3453098 elementor-widget elementor-widget-text-editor\" data-id=\"3453098\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\"><a href=\"https:\/\/operonstrategist.com\/en-gb\/\">Operon Strategist<\/a> 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 <a href=\"https:\/\/operonstrategist.com\/en-gb\/services\/regulatory-approvals\/ukca-marking\/\">UKCA marking<\/a><\/span><\/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\"><span style=\"font-weight: 400;\"><a href=\"https:\/\/operonstrategist.com\/en-gb\/services\/turnkey-project-consultants\/quality-management-system\/iso-13485\/\">ISO 13485<\/a> 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><div><p dir=\"ltr\" style=\"line-height: 1.38; margin-top: 12pt; margin-bottom: 12pt;\"><span style=\"font-size: 11pt; font-family: Arial, sans-serif; background-color: transparent; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-variant-position: normal; font-variant-emoji: normal; vertical-align: baseline; white-space-collapse: preserve;\">Stay compliant. Enter the UK market with confidence.<\/span><span style=\"font-size: 11pt; font-family: Arial, sans-serif; background-color: transparent; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-variant-position: normal; font-variant-emoji: normal; vertical-align: baseline; white-space-collapse: preserve;\"><br \/><\/span><span style=\"font-size: 11pt; font-family: Arial, sans-serif; background-color: transparent; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-variant-position: normal; font-variant-emoji: normal; vertical-align: baseline; white-space-collapse: preserve;\">Partner with <a href=\"https:\/\/operonstrategist.com\/en-gb\/\">Operon Strategist<\/a> \u2013 Your Regulatory Ally for UKRP &amp; Beyond!<\/span><\/p><div><span style=\"font-size: 11pt; font-family: Arial, sans-serif; background-color: transparent; font-weight: bold; font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-variant-position: normal; font-variant-emoji: normal; vertical-align: baseline; white-space-collapse: preserve;\">\u00a0<\/span><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>An Overview: 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 [&hellip;]<\/p>\n","protected":false},"author":7,"featured_media":3259,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[20],"tags":[],"class_list":["post-3258","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-ukca"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/en-gb\/wp-json\/wp\/v2\/posts\/3258","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/en-gb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/operonstrategist.com\/en-gb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-gb\/wp-json\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-gb\/wp-json\/wp\/v2\/comments?post=3258"}],"version-history":[{"count":5,"href":"https:\/\/operonstrategist.com\/en-gb\/wp-json\/wp\/v2\/posts\/3258\/revisions"}],"predecessor-version":[{"id":3271,"href":"https:\/\/operonstrategist.com\/en-gb\/wp-json\/wp\/v2\/posts\/3258\/revisions\/3271"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-gb\/wp-json\/wp\/v2\/media\/3259"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/en-gb\/wp-json\/wp\/v2\/media?parent=3258"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/operonstrategist.com\/en-gb\/wp-json\/wp\/v2\/categories?post=3258"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/operonstrategist.com\/en-gb\/wp-json\/wp\/v2\/tags?post=3258"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}