{"id":3641,"date":"2025-05-21T11:26:03","date_gmt":"2025-05-21T11:26:03","guid":{"rendered":"https:\/\/cmcmedicaldevices.com\/?p=3641"},"modified":"2025-07-18T10:10:14","modified_gmt":"2025-07-18T10:10:14","slug":"prrc-mdr-ivdr-role-requirements-and-compliance-duties","status":"publish","type":"post","link":"https:\/\/cmcmedicaldevices.com\/es\/prrc-mdr-ivdr-role-requirements-and-compliance-duties\/","title":{"rendered":"PRRC MDR IVDR: role, requirements and compliance duties"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><p><strong>What is the role of the PRRC?<\/strong><br \/>\nThe person responsible for regulatory compliance (PRRC) plays a key role in ensuring continuous compliance with EU MDR (2017\/745) and IVDR (2017\/746) throughout the lifecycle of medical and in vitro diagnostic devices. This article outlines what the PRRC does and why it matters for manufacturers.<\/p>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_74 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Alternar tabla de contenidos\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/cmcmedicaldevices.com\/es\/prrc-mdr-ivdr-role-requirements-and-compliance-duties\/#1_Qualifications_and_requirements_of_the_PRRC\" >1. Qualifications and requirements of the PRRC<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/cmcmedicaldevices.com\/es\/prrc-mdr-ivdr-role-requirements-and-compliance-duties\/#2_PRRC_vs_QP_in_the_United_Kingdom\" >2. PRRC vs. QP in the United Kingdom<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/cmcmedicaldevices.com\/es\/prrc-mdr-ivdr-role-requirements-and-compliance-duties\/#3_Integrating_the_PRRC_into_your_Quality_Management_System_QMS\" >3. Integrating the PRRC into your Quality Management System (QMS)<\/a><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"1_Qualifications_and_requirements_of_the_PRRC\"><\/span>1. Qualifications and requirements of the PRRC<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><b>Article 15 of both regulations defines the specific qualifications needed to serve as a PRRC<\/b>. Instead of relying on a symbolic role, companies must appoint someone with relevant expertise.<\/p>\n<p><strong>Education and experience:<\/strong><br \/>\nA qualified PRRC holds a university degree in a scientific discipline, such as medicine, pharmacy, or engineering and has at least one year of experience in regulatory affairs or quality management systems (QMS). Alternatively, professionals without a degree must demonstrate four years of related experience.<\/p>\n<p><strong>Specialised competence:<\/strong><br \/>\nThe PRRC must fully understand the MDR\/IVDR frameworks, risk management principles, conformity assessment procedures, and post-market obligations. In addition, they must know how to apply these rules to ensure product compliance.<\/p>\n<p><strong>Ongoing responsibility:<\/strong><br \/>\nThis individual actively supervises internal compliance efforts and continuously monitors regulatory updates. Therefore, the PRRC becomes a central reference for all matters related to regulatory alignment.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"2_PRRC_vs_QP_in_the_United_Kingdom\"><\/span>2. PRRC vs. QP in the United Kingdom<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>When the EU implemented the MDR, it required every medical device manufacturer and authorised representative to appoint a PRRC. Meanwhile, the UK introduced a comparable figure known as the <b>Qualified Person (QP)<\/b> under the <b>UK MDR 2002<\/b>. Although these roles share similar objectives, they differ in scope and implementation.<\/p>\n<p><b>The PRRC<\/b> contributes across the entire device lifecycle, from design and development to post-market surveillance. They verify technical documentation, oversee QMS compliance, and manage vigilance systems. In doing so, they help manufacturers maintain consistent regulatory alignment.<\/p>\n<p>Conversely, <b>the QP<\/b> primarily focuses on the final product release. They ensure each device meets UK standards before it enters the market. Unlike the PRRC, the QP operates more narrowly within production and certification stages. Additionally, their responsibilities are still being defined within the UK\u2019s post-Brexit regulatory framework.<\/p>\n<p><strong>In summary:<\/strong> the PRRC supports an integrated compliance strategy, while the QP concentrates on operational conformity at the release phase.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"3_Integrating_the_PRRC_into_your_Quality_Management_System_QMS\"><\/span>3. Integrating the PRRC into your Quality Management System (QMS)<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>For a company to fully benefit from a PRRC, it must embed this role into the broader QMS. When aligned correctly, the PRRC reinforces quality assurance across every department.<\/p>\n<p><strong>Processes and procedures:<\/strong><br \/>\nThe PRRC collaborates on document control protocols, supports audit planning, and ensures the implementation of corrective and preventive actions (CAPAs). As a result, the company gains a more robust compliance structure.<\/p>\n<p><strong>Cross-functional collaboration:<\/strong><br \/>\nThis role connects regulatory affairs with product development, manufacturing, and post-market teams. Such collaboration allows teams to detect issues early, respond faster to regulatory changes, and apply corrective actions more effectively.<\/p>\n<p><strong>Digital tools:<\/strong><br \/>\nBy using digital document management systems and integrated platforms, the PRRC can streamline workflows and improve traceability. These tools enhance their ability to track compliance and ensure accuracy.<\/p>\n<p><strong>The PRRC is not merely a requirement, it is a strategic position.<\/strong> This individual supports regulatory excellence, improves patient safety, and strengthens a company\u2019s reputation in global medical device markets.<\/p>\n<p><strong>The regulatory landscape evolves constantly.<\/strong> Stay informed with expert articles, practical guidance, and the latest updates on MDR and IVDR compliance.<\/p>\n<\/div><div style=\"text-align:center;\"><a class=\"fusion-button button-flat fusion-button-default-size button-default fusion-button-default button-1 fusion-button-default-span fusion-button-default-type\" style=\"--button_margin-top:10px;--button_margin-bottom:20px;\" target=\"_blank\" rel=\"noopener noreferrer\" href=\"https:\/\/cmcmedicaldevices.com\/contact\/\"><span class=\"fusion-button-text\">Contact us for more information<\/span><\/a><\/div><div class=\"fusion-image-element \" 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class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n    <\/div>\n<\/div>\n                \n\n<div class=\"kksr-legend\" style=\"font-size: 19.2px;\">\n            5\/5 - (3 votos)    <\/div>\n    <\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"gallery","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-3641","post","type-post","status-publish","format-gallery","hentry","category-sin-categorizar","post_format-post-format-gallery"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.3.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>PRRC MDR IVDR: role, requirements and compliance duties<\/title>\n<meta name=\"description\" content=\"Learn who the PRRC is under MDR\/IVDR, what their role involves, and how they impact medical device compliance from design to post-market.\" \/>\n<meta name=\"robots\" content=\"noindex, follow\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta 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