{"id":7059,"date":"2026-06-04T14:22:10","date_gmt":"2026-06-04T08:52:10","guid":{"rendered":"https:\/\/operonstrategist.com\/?p=7059"},"modified":"2026-06-04T14:22:10","modified_gmt":"2026-06-04T08:52:10","slug":"roles-of-prrc","status":"publish","type":"post","link":"https:\/\/operonstrategist.com\/eg-en\/roles-of-prrc\/","title":{"rendered":"Roles of PRRC (Person Responsible for Regulatory Compliance)"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"7059\" class=\"elementor elementor-7059\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-610207d0 e-flex e-con-boxed e-con e-parent\" data-id=\"610207d0\" 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-43731942 elementor-widget elementor-widget-heading\" data-id=\"43731942\" 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\">Roles of PRRC (Person Responsible for Regulatory 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-66c3a6b7 e-flex e-con-boxed e-con e-parent\" data-id=\"66c3a6b7\" 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-3d7b25cf e-con-full e-flex e-con e-child\" data-id=\"3d7b25cf\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1e64013 elementor-widget elementor-widget-heading\" data-id=\"1e64013\" 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 PRRC? \n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5effc7a6 elementor-widget elementor-widget-text-editor\" data-id=\"5effc7a6\" 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;\">PRRC is an acronym of \u201cPerson Responsible for Regulatory Compliance\u201d. EUMDR introduces new requirements for the medical devices manufacturers, which explains the roles of PRRC. According to the new regulation of EUMDR, which came into force on 26 May 2021 the medical device manufacturer should have a PRRC to keep an eye on regulatory compliance. PRRC plays vital roles and responsibilities in setting up the plants for manufacturing medical devices.<\/span><\/p><p><span style=\"font-weight: 400;\">The PRRC\u2019s are the authorized person who should have some specific qualification and experience. EU has published new rules and regulations for \u00a0 medical devices manufacturers that these companies or organizations should have PRRC with them to look out the matter of regulations and policies PRRC is responsible for regulatory compliance Article 15(1) of MDR and IVDR has outlined some specific prerequisites for PRRC. <\/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-41565204 e-con-full e-flex e-con e-child\" data-id=\"41565204\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-b2416fd e-con-full e-flex e-con e-child\" data-id=\"b2416fd\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3178b36a elementor-widget elementor-widget-heading\" data-id=\"3178b36a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Regulatory Excellence for Global Medical Device Markets<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-601dbfe5 elementor-widget elementor-widget-wpforms\" data-id=\"601dbfe5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"wpforms.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"wpforms-container wpforms-container-full wpforms-render-modern\" id=\"wpforms-6203\"><form id=\"wpforms-form-6203\" class=\"wpforms-validate wpforms-form wpforms-ajax-form\" data-formid=\"6203\" method=\"post\" enctype=\"multipart\/form-data\" action=\"\/eg-en\/wp-json\/wp\/v2\/posts\/7059\" data-token=\"947330bc31d331298c2701c8bb1074b8\" data-token-time=\"1780573921\"><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><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>\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\" >Text Name Email<\/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_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\/eg-en\/wp-json\/wp\/v2\/posts\/7059\"><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-757e5048 e-flex e-con-boxed e-con e-parent\" data-id=\"757e5048\" 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-1351aa77 elementor-widget elementor-widget-text-editor\" data-id=\"1351aa77\" 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 medical device manufacturer who wishes to sell\/supply their device in European Union they must have at least one Person Responsible for Regulatory Compliance (PRRC) at their site of disposal. As a medical device consultant we know the importance of PRRC and <\/span><a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/ce-marking\/\"><span style=\"font-weight: 400;\">CE marking certification<\/span><\/a><span style=\"font-weight: 400;\"> and we help our clients in regulatory compliance process.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-da566bb elementor-widget elementor-widget-heading\" data-id=\"da566bb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Who can be PRRC?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5a05f38 elementor-widget elementor-widget-text-editor\" data-id=\"5a05f38\" 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 can be any person who has the requisite expertise in the field of medical devices and requisite expertise shall be demonstrated by the qualifications below.\u202f\u00a0<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The person shall hold a Diploma or University Degree in Law, Medicine, Pharmacy, Engineering and other relevant disciplines recognized by the member state and have at least one year\u2019s experience in Quality Management of medical devices.\u00a0<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">Or\u00a0<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Four years of professional experience in regulatory affairs or Quality Management systems relating to Medical Devices.\u00a0<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">If you are the manufacturer of custom-made devices without prejudice to national provisions regarding professional qualifications, the manufacturer may demonstrate the requisite expertise by having at least two years of professional experience within a relevant field of manufacturing. If a manufacturer does not have a person who can meet the above prerequisites, then they can\u00a0<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Hire a new employee who will fulfil this role.\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Hire a consultant for some period of time and simultaneously train your existing employee.\u00a0<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">The small manufacturers&#8217; fewer employees (less than 50) can outsource the experts as PRRC with fulfilling all criteria, which means the micro\/small enterprises who don\u2019t have a person within their organization then the responsibility can be taken care by a consultant who is \u201cpermanently \u201cor continuously\u201d available for the site. Manufacturers can have more than one PRRC if they meet the above stated prerequisites, they need to define their roles and responsibilities. <\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2900fd4 elementor-widget elementor-widget-heading\" data-id=\"2900fd4\" 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 are the Roles of PRRC and Responsibilities of PRRC?\u202f\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b6d762b elementor-widget elementor-widget-text-editor\" data-id=\"b6d762b\" 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;\">The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released.<\/span><\/li><\/ul><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Keeping technical file and EC Declaration of conformity up to date.<\/span><\/li><\/ul><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The compliance and effectiveness of internal process leading to product,<\/span><\/li><\/ul><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Continuously monitor the Post market activities of medical devices,<\/span><\/li><\/ul><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Reporting analysis of serious incidents, field safety corrective actions (FSCA), analysis of vigilance and trend reporting,<\/span><\/li><\/ul><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">PRRC shall inform the authorized representative, importer, distributor and notified body in case of any serious adverse action observe or occur,<\/span><\/li><\/ul><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Notification to authorities in the case of any change or update of technical documents,<\/span><\/li><\/ul><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Applicability of international standard and applicability compliance of external processes, including potentially sourcing and manufacturing,<\/span><\/li><\/ul><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Maintenance and check effectiveness of the quality management system and its effect on the performance of the devices manufacturer,<\/span><\/li><\/ul><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The PRRC will ensure the promotion of customer requirements throughout the organization<\/span><\/li><\/ul><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Keep in touch with authorized representative, importer, distributor, notified body and conformity assessment,<\/span><\/li><\/ul><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">On EUDAMED the PRRC be act as local actor Administration (LAA) on behalf of the manufacturer,<\/span><\/li><\/ul><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Manage all the EUDAMED related activities.<\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-76462c0 elementor-widget elementor-widget-heading\" data-id=\"76462c0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Who needs to appoint PRRC? \n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-43f303a elementor-widget elementor-widget-text-editor\" data-id=\"43f303a\" 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;\">Manufacturers\u00a0\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Importers, distributors and other people who are acting as manufacturers.\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Authorized representative.\u00a0<\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9271c2d elementor-widget elementor-widget-heading\" data-id=\"9271c2d\" 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\">Does an Authorized Representative require a PRRC?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-37b4840 elementor-widget elementor-widget-text-editor\" data-id=\"37b4840\" 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, your authorized representative must have a PRRC permanently and continuously at their disposal. The PRRC shall possess the appropriate qualification and experience as discussed in point no. 01.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7c8fb3a elementor-widget elementor-widget-heading\" data-id=\"7c8fb3a\" 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\">Appointment of PRRC\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a64cabf elementor-widget elementor-widget-text-editor\" data-id=\"a64cabf\" 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;\">Appointment of the PRRC is similar to how you appoint your management representative. You have to create and sign the agreement with the PRRC, with the following information<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Purpose<\/span><\/li><\/ul><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Scope<\/span><\/li><\/ul><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Qualification requirement<\/span><\/li><\/ul><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Roles of PRRC and responsibilities of PRRC<\/span><\/li><\/ul><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Any additional Roles and responsibilities<\/span><\/li><\/ul><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Date and signature of the PRRC and Company Head.<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">The manufacturer needs to ensure that PRRC shall suffer no disadvantage within the manufacturer\u2019s organization in relation to the proper fulfilment of his or her duties, regardless of whether or not they are employees of the organization. The manufacturer should note that only qualified representatives can perform the role of PRRC.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e36d8f2 elementor-widget elementor-widget-heading\" data-id=\"e36d8f2\" 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 the importance of identifying PRRC? \n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c1efbd5 elementor-widget elementor-widget-text-editor\" data-id=\"c1efbd5\" 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;\">Identifying the PRRC for your organization is a most important requirement that applies to the European Union and is a core area of responsibility for a person or persons under the medical device regulation, or In vitro device regulation. The directive to appoint the PRRC also depends on the size of the organization. This is mandatory requirement for any CE Marking under the new EU MDR\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">The motivation for identifying the PRRC positions is so that there is a qualified regulatory expert directly responsible for the manufacturing and the market surveillance and reporting systems to ensure the company is meeting the European Union requirements.\u00a0 Companies are not limited to one PRRC and the responsibilities can be allocated to several people, as long as the requirements concerning qualification are met and the distribution of the respective areas of responsibility are documented. If the responsibilities are divided among more than one person, ensure that all responsibilities are covered.\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">The Regulations have a clear desire to add an additional level of scrutiny to the supervision and control of the manufacturing of medical devices, as well as relevant post-market surveillance and vigilance activities. Thus, identifying the PRRC role is purposefully a sole position from the European Union Authorized Representative. The importance of identifying the PRRC role by the MDR and IVDR goes beyond the role of a safety officer. MDCG 2019-7 provides the prescriptive guidance for PRRC in terms of qualification and responsibility. The manufacturer needs to identify the person who can cover this crucial role.\u00a0\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">The right way of Identifying the PRRC is, if he\u2019s responsible for the technical documentation EU Declaration of Conformity (drawn up and kept up-to-date), post-market surveillance obligations and checking the conformity of devices before they are released (according to the quality management system implemented). Each legal manufacturer must have its own PRRC. The PRRC must be close to the manufacturer, which means that if the manufacturer is located in the EU, its PRRC must also be located in the EU.\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">At <\/span><a href=\"https:\/\/operonstrategist.com\/\"><span style=\"font-weight: 400;\">Operon Strategist<\/span><\/a><span style=\"font-weight: 400;\"> we understand the complications of regulatory compliance and to make it easy for our clients we provide support and guidance. You can contact us anytime for regulatory support and for detailed information.\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">\u00a0Reference : <\/span><a href=\"https:\/\/www.medical-device-regulation.eu\/2019\/07\/04\/mdr-article-15-person-responsible-for-regulatory-compliance\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">https:\/\/www.medical-device-regulation.eu\/2019\/07\/04\/mdr-article-15-person-responsible-for-regulatory-compliance\/<\/span><\/a><span style=\"font-weight: 400;\">\u00a0<\/span><\/p><p><br \/><br \/><\/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\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>What is PRRC? PRRC is an acronym of \u201cPerson Responsible for Regulatory Compliance\u201d. EUMDR introduces new requirements for the medical devices manufacturers, which explains the roles of PRRC. According to the new regulation of EUMDR, which came into force on 26 May 2021 the medical device manufacturer should have a PRRC to keep an eye [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":8662,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[55],"tags":[],"class_list":["post-7059","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulatory"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/posts\/7059","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/comments?post=7059"}],"version-history":[{"count":0,"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/posts\/7059\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/media\/8662"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/media?parent=7059"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/categories?post=7059"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/tags?post=7059"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}