{"id":6837,"date":"2026-06-12T15:18:54","date_gmt":"2026-06-12T09:48:54","guid":{"rendered":"https:\/\/operonstrategist.com\/?p=6837"},"modified":"2026-06-12T15:18:54","modified_gmt":"2026-06-12T09:48:54","slug":"prrc-under-eu-mdr-and-ivdr","status":"publish","type":"post","link":"https:\/\/operonstrategist.com\/za-en\/prrc-under-eu-mdr-and-ivdr\/","title":{"rendered":"PRRC Under EU MDR and IVDR: Roles, Responsibilities &#038; Compliance"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"6837\" class=\"elementor elementor-6837\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3f3d33a0 e-flex e-con-boxed e-con e-parent\" data-id=\"3f3d33a0\" 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-6393d811 elementor-widget elementor-widget-heading\" data-id=\"6393d811\" 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\">PRRC Under EU MDR and IVDR: Roles, Responsibilities &#038; Compliance<\/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-f87bf03 e-flex e-con-boxed e-con e-parent\" data-id=\"f87bf03\" 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-2067d14d e-con-full e-flex e-con e-child\" data-id=\"2067d14d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-16225bd2 elementor-widget elementor-widget-heading\" data-id=\"16225bd2\" 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\">Are You EU MDR\/IVDR Compliant? The PRRC Role Explained\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4f0134db elementor-widget elementor-widget-text-editor\" data-id=\"4f0134db\" 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 Person Responsible for Regulatory Compliance (PRRC) plays a crucial role in ensuring compliance with the Medical Device Regulation (MDR) (EU 2017\/745) and In Vitro Diagnostic Regulation (IVDR) (EU 2017\/746). This mandatory position safeguards regulatory integrity and ensures medical devices meet EU compliance standards.\u00a0<\/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-f5f6a0c e-con-full e-flex e-con e-child\" data-id=\"f5f6a0c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-4c116d4d e-con-full e-flex e-con e-child\" data-id=\"4c116d4d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3817fe1f elementor-widget elementor-widget-heading\" data-id=\"3817fe1f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Talk to our experts<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-48b10684 elementor-widget elementor-widget-wpforms\" data-id=\"48b10684\" 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=\"\/za-en\/wp-json\/wp\/v2\/posts\/6837\" data-token=\"e49cf1a40e184c59232e0c59e94a0476\" data-token-time=\"1781276665\"><noscript class=\"wpforms-error-noscript\">Please enable JavaScript in your browser to complete this form.<\/noscript><div id=\"wpforms-error-noscript\" style=\"display: none;\">Please enable JavaScript in your browser to complete this form.<\/div><div class=\"wpforms-field-container\"><div id=\"wpforms-6203-field_1-container\" class=\"wpforms-field wpforms-field-name\" data-field-id=\"1\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_1\" aria-hidden=\"false\">Name <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"text\" id=\"wpforms-6203-field_1\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][1]\" placeholder=\"Name*\" aria-errormessage=\"wpforms-6203-field_1-error\" required><\/div>\t\t<div id=\"wpforms-6203-field_5-container\"\n\t\t\tclass=\"wpforms-field wpforms-field-text\"\n\t\t\tdata-field-type=\"text\"\n\t\t\tdata-field-id=\"5\"\n\t\t\t>\n\t\t\t<label class=\"wpforms-field-label\" for=\"wpforms-6203-field_5\" >Name Email Text<\/label>\n\t\t\t<input type=\"text\" id=\"wpforms-6203-field_5\" class=\"wpforms-field-medium\" name=\"wpforms[fields][5]\" >\n\t\t<\/div>\n\t\t<div id=\"wpforms-6203-field_2-container\" class=\"wpforms-field wpforms-field-email\" data-field-id=\"2\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_2\" aria-hidden=\"false\">Email <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"email\" id=\"wpforms-6203-field_2\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][2]\" placeholder=\"Email*\" spellcheck=\"false\" aria-errormessage=\"wpforms-6203-field_2-error\" required><\/div><div id=\"wpforms-6203-field_3-container\" class=\"wpforms-field wpforms-field-phone\" data-field-id=\"3\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_3\" aria-hidden=\"false\">Phone <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"tel\" id=\"wpforms-6203-field_3\" class=\"wpforms-field-large wpforms-field-required wpforms-smart-phone-field\" data-rule-smart-phone-field=\"true\" name=\"wpforms[fields][3]\" placeholder=\"Phone*\" aria-label=\"Phone\" aria-errormessage=\"wpforms-6203-field_3-error\" required><\/div><div id=\"wpforms-6203-field_4-container\" class=\"wpforms-field wpforms-field-textarea\" data-field-id=\"4\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_4\" aria-hidden=\"false\">Paragraph Text <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><textarea id=\"wpforms-6203-field_4\" class=\"wpforms-field-medium wpforms-field-required\" name=\"wpforms[fields][4]\" placeholder=\"Message\" aria-errormessage=\"wpforms-6203-field_4-error\" required><\/textarea><\/div><script>\n\t\t\t\t( function() {\n\t\t\t\t\tconst style = document.createElement( 'style' );\n\t\t\t\t\tstyle.appendChild( document.createTextNode( '#wpforms-6203-field_5-container { position: absolute !important; overflow: hidden !important; display: inline !important; height: 1px !important; width: 1px !important; z-index: -1000 !important; padding: 0 !important; } #wpforms-6203-field_5-container input { visibility: hidden; } #wpforms-conversational-form-page #wpforms-6203-field_5-container label { counter-increment: none; }' ) );\n\t\t\t\t\tdocument.head.appendChild( style );\n\t\t\t\t\tdocument.currentScript?.remove();\n\t\t\t\t} )();\n\t\t\t<\/script><\/div><!-- .wpforms-field-container --><div class=\"wpforms-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\/za-en\/wp-json\/wp\/v2\/posts\/6837\"><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-c356474 e-flex e-con-boxed e-con e-parent\" data-id=\"c356474\" 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-18118f5d elementor-widget elementor-widget-heading\" data-id=\"18118f5d\" 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 PRRC?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6f63b9e9 elementor-widget elementor-widget-text-editor\" data-id=\"6f63b9e9\" 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 Person Responsible for Regulatory Compliance (PRRC) is a legally mandated role under Article 15 of EU MDR (EU 2017\/745) and IVDR (EU 2017\/746). Every manufacturer and authorized representative (AR) must appoint a PRRC to ensure regulatory compliance with EU medical device laws.\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">Did you know? Micro and small manufacturers must have a PRRC, although they can outsource this role under certain conditions (MDCG 2019-7). <\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7ecfc94 elementor-widget elementor-widget-heading\" data-id=\"7ecfc94\" 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\">Qualifications &amp; Eligibility\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-18de8ff elementor-widget elementor-widget-text-editor\" data-id=\"18de8ff\" 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;\">To become a PRRC, a professional must have:\u00a0<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">A relevant university degree in law, medicine, engineering, or another related field, <\/span><i><span style=\"font-weight: 400;\">or<\/span><\/i><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">At least four years of experience in regulatory affairs or quality management within the medical device industry.<\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-dc1a4ea elementor-widget elementor-widget-heading\" data-id=\"dc1a4ea\" 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 PRRC\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2f69639 elementor-widget elementor-widget-text-editor\" data-id=\"2f69639\" 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 PRRC ensures compliance with:\u00a0<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Technical Documentation<\/span><span style=\"font-weight: 400;\"> &amp; <\/span><a href=\"https:\/\/operonstrategist.com\/eu-declaration-of-conformity-for-medical-devices-all-you-need-to-know\/\"><span style=\"font-weight: 400;\">EU Declarations of Conformity<\/span><\/a><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/operonstrategist.com\/post-market-surveillance-for-medical-devices\/\"><span style=\"font-weight: 400;\">Post-Market Surveillance<\/span><\/a><span style=\"font-weight: 400;\"> (PMS) Systems &amp; Reporting Obligations (Articles 87\u201391 for MDR, 82\u201386 for IVDR)<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Investigational Device Conformity Statements (Annex XV of MDR)<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Maintaining Up-to-Date Records &amp; Documents<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">PRRCs must be permanently available<\/span><span style=\"font-weight: 400;\"> to manufacturers or authorized representatives to ensure smooth regulatory oversight.<\/span><\/p><p>Also Read <a href=\"https:\/\/operonstrategist.com\/roles-of-prrc\/\">The Roles of PRRC (Person Responsible for Regulatory Compliance).<\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d27959b elementor-widget elementor-widget-heading\" data-id=\"d27959b\" 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\">PRRC for Manufacturers vs. Authorized Representatives\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3602325 elementor-widget elementor-widget-text-editor\" data-id=\"3602325\" 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;\">PRRCs must be permanently available<\/span><span style=\"font-weight: 400;\"> to manufacturers or authorized representatives to ensure smooth regulatory oversight. <\/span><\/p><p><span style=\"font-weight: 400;\">Important: A PRRC cannot serve both the manufacturer and authorized representative roles simultaneously to prevent biased oversight.\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ca7ea4d elementor-widget elementor-widget-heading\" data-id=\"ca7ea4d\" 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\">PRRC Compliance &amp; EUDAMED Registration<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d169931 elementor-widget elementor-widget-text-editor\" data-id=\"d169931\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Every PRRC must:\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Be officially documented within the manufacturer\u2019s or AR\u2019s compliance system.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Remain independent to ensure impartiality.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Have their name and contact details registered in EUDAMED, enhancing traceability.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Follow a risk-based approach depending on the classification of the medical device.<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">Are PRRCs personally liable? No, PRRCs are not personally responsible for regulatory violations. Their role is to ensure processes comply with regulations. <\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b4c73d2 elementor-widget elementor-widget-heading\" data-id=\"b4c73d2\" 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\">Need Help with PRRC Compliance?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d6d833d elementor-widget elementor-widget-text-editor\" data-id=\"d6d833d\" 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 role of a Person Responsible for Regulatory Compliance (PRRC) under MDR &amp; IVDR can be challenging, but you don\u2019t have to navigate it alone. At Operon Strategist, we help manufacturers and authorized representatives meet EU regulatory requirements with ease.\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">From PRRC eligibility and responsibilities to EUDAMED registration and <\/span><a href=\"https:\/\/operonstrategist.com\/post-market-surveillance-for-medical-devices\/\"><span style=\"font-weight: 400;\">post-market surveillance<\/span><\/a><span style=\"font-weight: 400;\">, our experts ensure you\u2019re on the right track.\u00a0<\/span><span style=\"font-weight: 400;\">Let\u2019s simplify compliance together! <\/span><a href=\"https:\/\/operonstrategist.com\/contact-us\/\"><span style=\"font-weight: 400;\">Reach out to us<\/span><\/a><span style=\"font-weight: 400;\"> today and keep your medical devices market-ready! <\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-36682a60 e-con-full e-flex e-con e-child\" data-id=\"36682a60\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-36601ab7 elementor-widget elementor-widget-heading\" data-id=\"36601ab7\" 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's<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-462fb7c1 elementor-widget elementor-widget-n-accordion\" data-id=\"462fb7c1\" 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-1170\" 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-1170\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Can a company outsource its PRRC role? <\/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-1170\" class=\"elementor-element elementor-element-2a11349a e-con-full e-flex e-con e-child\" data-id=\"2a11349a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9c5f6a0 elementor-widget elementor-widget-text-editor\" data-id=\"9c5f6a0\" 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, small and micro-manufacturers can outsource this role, provided the external PRRC is permanently available (MDCG 2019-7).<\/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-1171\" 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-1171\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What happens if a manufacturer does not appoint a PRRC? <\/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-1171\" class=\"elementor-element elementor-element-3a8c9c48 e-con-full e-flex e-con e-child\" data-id=\"3a8c9c48\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-69eadc8c elementor-widget elementor-widget-text-editor\" data-id=\"69eadc8c\" 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;\">Failure to appoint a PRRC can lead to regulatory action, fines, or even product removal from the EU 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-1172\" 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-1172\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Is a PRRC required for virtual manufacturers? <\/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-1172\" class=\"elementor-element elementor-element-6237d1ef e-con-full e-flex e-con e-child\" data-id=\"6237d1ef\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-206e5b9f elementor-widget elementor-widget-text-editor\" data-id=\"206e5b9f\" 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! Virtual manufacturers must ensure that their OEM (Original Equipment Manufacturer) complies with EUMDR\/IVDR requirements.<\/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\":\"Can a company outsource its PRRC role?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Yes, small and micro-manufacturers can outsource this role, provided the external PRRC is permanently available (MDCG 2019-7).\"}},{\"@type\":\"Question\",\"name\":\"What happens if a manufacturer does not appoint a PRRC?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Failure to appoint a PRRC can lead to regulatory action, fines, or even product removal from the EU market.\"}},{\"@type\":\"Question\",\"name\":\"Is a PRRC required for virtual manufacturers?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Yes! Virtual manufacturers must ensure that their OEM (Original Equipment Manufacturer) complies with EUMDR\\\/IVDR requirements.\"}}]}<\/script>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Are You EU MDR\/IVDR Compliant? The PRRC Role Explained The Person Responsible for Regulatory Compliance (PRRC) plays a crucial role in ensuring compliance with the Medical Device Regulation (MDR) (EU 2017\/745) and In Vitro Diagnostic Regulation (IVDR) (EU 2017\/746). This mandatory position safeguards regulatory integrity and ensures medical devices meet EU compliance standards. Talk to [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":15252,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[55],"tags":[],"class_list":["post-6837","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulatory"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/za-en\/wp-json\/wp\/v2\/posts\/6837","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/za-en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/operonstrategist.com\/za-en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/za-en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/za-en\/wp-json\/wp\/v2\/comments?post=6837"}],"version-history":[{"count":6,"href":"https:\/\/operonstrategist.com\/za-en\/wp-json\/wp\/v2\/posts\/6837\/revisions"}],"predecessor-version":[{"id":15253,"href":"https:\/\/operonstrategist.com\/za-en\/wp-json\/wp\/v2\/posts\/6837\/revisions\/15253"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/za-en\/wp-json\/wp\/v2\/media\/15252"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/za-en\/wp-json\/wp\/v2\/media?parent=6837"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/operonstrategist.com\/za-en\/wp-json\/wp\/v2\/categories?post=6837"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/operonstrategist.com\/za-en\/wp-json\/wp\/v2\/tags?post=6837"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}