{"id":921,"date":"2024-02-19T14:48:06","date_gmt":"2024-02-19T13:48:06","guid":{"rendered":"https:\/\/www.biotopmedical.nl\/?page_id=921"},"modified":"2026-09-14T14:00:31","modified_gmt":"2026-09-14T12:00:31","slug":"person-responsible-for-regulatory-compliance","status":"publish","type":"page","link":"https:\/\/www.biotopmedical.nl\/nl\/person-responsible-for-regulatory-compliance\/","title":{"rendered":"Person Responsible for Regulatory Compliance"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row full_width=&#8221;stretch_row&#8221; content_placement=&#8221;bottom&#8221; bg_color=&#8221;bg_purple&#8221; bg_fade=&#8221;fade_white&#8221; css=&#8221;.vc_custom_1670580737571{background-image: url(https:\/\/www.biotopmedical.nl\/wp-content\/uploads\/2022\/11\/home_banner.jpg?id=505) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}&#8221;][vc_column width=&#8221;7\/12&#8243;]\r\n        <div class=\"sd-block-breadcrumb  align-left marginbottom-20px\r\n        \">\r\n            <ul id=\"breadcrumbs\" class=\"breadcrumbs\">\r\n            <li class=\"item-home\"><a class=\"bread-link bread-home\" href=\"https:\/\/www.biotopmedical.nl\/nl\/\" title=\"Home\">Home<\/a><\/li>\r\n            <li class=\"separator separator-home\"> > <\/li><\/ul>\r\n        <\/div>\r\n        <div class=\"sd-block-title  align-left\">\r\n            <h1 class=\"sd-block-title-htag  marginbottom-20px align-left color-white bg bg-purple\r\n            \">Person Responsible for Regulatory Compliance<\/h1>\r\n        <\/div>\r\n        <div class=\"sd-block-title  align-left\">\r\n            <h2 class=\"sd-block-title-htag  marginbottom-40px align-left color-purple bg bg-white\r\n            \">Aan uw PRRC-verplichting voldoen onder de MDR en IVDR<\/h2>\r\n        <\/div>[\/vc_column][vc_column css_animation=&#8221;fadeInUp&#8221; width=&#8221;5\/12&#8243;]\r\n            <a class=\"sd-block-cta  marginbottom-0px white duocolor\" title=\"Laat ons uw PRRC-rol overnemen\" href=\"#contact\"\r\n                >\r\n                    <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" version=\"1.1\" id=\"Layer_1\" x=\"0px\" y=\"0px\" viewBox=\"0 0 232.2 126.4\" style=\"enable-background:new 0 0 232.2 126.4;\" xml:space=\"preserve\"> <style type=\"text\/css\"> .st0{fill:#5B358C;} .st1{fill:#E42313;} .st2{fill:#FFFFFF;} <\/style> <g> <polygon class=\"st0\" points=\"0,62.3 0,17 113.5,17 113.5,53.9 232.2,53.9 232.2,99.2 105.9,99.2 105.9,62.3 \"><\/polygon> <path class=\"st1\" d=\"M147.9,11.4c0,0-6.7,0.6-11.1-0.7c-2.7-0.9-5.3-3.3-8.2-2.8c-4.5,0.8-8.7,2.4-10.7,6.8 c-1.6,3.4-1.6,8.3,4.1,15.1c5.7,6.7,9.4,14,5.8,21.9c-3.3,7.2-10.3,9.4-18.3,9.7c-8,0.3-13.3,3-15.2,7.2c-1.7,3.7-0.8,9.7,2.3,15.7 c2.7,5.2,8.3,15.2,5.5,21.1c-6,12.4-23.3,21.1-23.3,21.1l-0.2-0.2c0,0,15.7-13.3,17.7-23.3c0.6-3.1-1.5-9.6-5.2-16 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           <h2 class=\"sd-block-title-htag  marginbottom-0px align-left color-white bg bg-purple\r\n            \">Laat ons uw PRRC-rol overnemen<\/h2>\r\n        <\/div>\r\n                        <div class=\"cta-content\">\r\n                            \r\n        <div class=\"sd-block-text  marginbottom-40px color-black\r\n        \">\r\n            <p>Wij kunnen optreden als uw externe PRRC of uw bestaande team ondersteunen. Neem contact met ons op om te bespreken hoe een PRRC-samenwerking er voor uw bedrijf uit zou zien.<\/p>\n\r\n        <\/div>\r\n                            \r\n        <div class=\"sd-block-button  marginbottom-0px style-transparent color-purple\">\r\n            <span href=\"\" title=\"Neem contact op\">Neem contact op<\/span>\r\n        <\/div>\r\n                        <\/div>\r\n                    \r\n            <\/a>[\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; equal_height=&#8221;yes&#8221; css=&#8221;.vc_custom_1662038703013{padding-top: 0px !important;padding-bottom: 0px !important;}&#8221; el_class=&#8221;sidebar-row&#8221;][vc_column width=&#8221;3\/4&#8243; css=&#8221;.vc_custom_1745843610440{margin-top: 80px !important;}&#8221;]\r\n        <div class=\"sd-block-text  marginbottom-40px\r\n        \">\r\n            <p>Intern iemand vinden die voldoet aan de PRRC-eisen onder de MDR en IVDR is niet eenvoudig, zeker niet als uw bedrijf minder dan 50 medewerkers heeft. Het regulatory team van Biotop Medical kan deze rol voor u vervullen: wij verzorgen de vrijgave van hulpmiddelen, technische documentatie, uw conformiteitsverklaring, post-market surveillance en meldplichten.<\/p>\n\r\n        <\/div>\r\n        <div class=\"sd-block-title  align-left\">\r\n            <h2 class=\"sd-block-title-htag  marginbottom-40px align-left color-purple bg bg-lightpurple font-middle\r\n            \">Biotop vervult de PRRC-rol<\/h2>\r\n        <\/div>\r\n        <div class=\"sd-block-title  align-left\">\r\n            <h3 class=\"sd-block-title-htag  marginbottom-20px align-left color-purple bg bg-lightpurple font-small\r\n            \">Team PRRC<\/h3>\r\n        <\/div>\r\n        <div class=\"sd-block-text  marginbottom-40px\r\n        \">\r\n            <p>Het PRRC-team van Biotop deelt de kennis van uw dossiers, zodat de continu\u00efteit gewaarborgd blijft, ook als iemand afwezig is of een andere rol krijgt. Via Biotop heeft u altijd een gekwalificeerde PRRC beschikbaar, zonder afhankelijk te zijn van \u00e9\u00e9n persoon.<\/p>\n\r\n        <\/div>\r\n        <div class=\"sd-block-title  align-left\">\r\n            <h2 class=\"sd-block-title-htag  marginbottom-40px align-left color-purple bg bg-lightpurple font-middle\r\n            \">Onze verantwoordelijkheden als PRRC<\/h2>\r\n        <\/div>[vc_row_inner][vc_column_inner width=&#8221;1\/2&#8243;]\r\n        <div class=\"sd-block-title  align-left\">\r\n            <h3 class=\"sd-block-title-htag  marginbottom-20px align-left color-purple bg bg-lightpurple font-small\r\n            \">Vrijgave van hulpmiddelen<\/h3>\r\n        <\/div>\r\n        <div class=\"sd-block-text  marginbottom-40px\r\n        \">\r\n            <p>Voordat een batch hulpmiddelen wordt vrijgegeven, controleert Biotop of uw productie- en kwaliteitsprocedures zijn gevolgd. Die controle gebeurt direct, zodat de vrijgave niet vertraagd wordt door onze kant.<\/p>\n\r\n        <\/div>[\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;]\r\n        <div class=\"sd-block-title  align-left\">\r\n            <h3 class=\"sd-block-title-htag  marginbottom-20px align-left color-purple bg bg-lightpurple font-small\r\n            \">Technische documentatie<\/h3>\r\n        <\/div>\r\n        <div class=\"sd-block-text  marginbottom-40px\r\n        \">\r\n            <p>Biotop toetst uw <a href=\"https:\/\/www.biotopmedical.nl\/nl\/technische-documentatie\/\">technische documentatie<\/a> aan de algemene veiligheids- en prestatie-eisen van de MDR en IVDR, en signaleert wat ontbreekt voordat dit een probleem wordt tijdens een audit.<\/p>\n\r\n        <\/div>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner width=&#8221;1\/2&#8243;]\r\n        <div class=\"sd-block-title  align-left\">\r\n            <h3 class=\"sd-block-title-htag  marginbottom-20px align-left color-purple bg bg-lightpurple font-small\r\n            \">Conformiteitsverklaring<\/h3>\r\n        <\/div>\r\n        <div class=\"sd-block-text  marginbottom-40px\r\n        \">\r\n            <p>Een conformiteitsverklaring kan pas worden ondertekend nadat uw PRRC heeft geverifieerd dat het hulpmiddel aan de toepasselijke eisen voldoet. Biotop voert die verificatie uit en helpt u een verklaring op te stellen die bestand is tegen nauwkeurige controle.<\/p>\n\r\n        <\/div>[\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;]\r\n        <div class=\"sd-block-title  align-left\">\r\n            <h3 class=\"sd-block-title-htag  marginbottom-20px align-left color-purple bg bg-lightpurple font-small\r\n            \">Post-market surveillance<\/h3>\r\n        <\/div>\r\n        <div class=\"sd-block-text  marginbottom-40px\r\n        \">\r\n            <p>Zodra een hulpmiddel op de markt is, monitort Biotop namens u hoe het presteert. Biotop helpt u post-market surveillance op te zetten die bruikbare gegevens oplevert, en zorgt ervoor dat die gegevens ook daadwerkelijk beoordeeld worden, niet alleen worden gearchiveerd.<\/p>\n\r\n        <\/div>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner width=&#8221;1\/2&#8243;]\r\n        <div class=\"sd-block-title  align-left\">\r\n            <h3 class=\"sd-block-title-htag  marginbottom-20px align-left color-purple bg bg-lightpurple font-small\r\n            \">Meldplichten<\/h3>\r\n        <\/div>\r\n        <div class=\"sd-block-text  marginbottom-40px\r\n        \">\r\n            <p>Vigilantie en het melden van incidenten vallen onder de verantwoordelijkheid van uw PRRC. Biotop helpt u herkennen wat gemeld moet worden en verzorgt de communicatie met de bevoegde autoriteiten, zodat meldtermijnen worden gehaald.<\/p>\n\r\n        <\/div>[\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;]\r\n        <div class=\"sd-block-title  align-left\">\r\n            <h3 class=\"sd-block-title-htag  marginbottom-20px align-left color-purple bg bg-lightpurple font-small\r\n            \">Gebaseerd op Artikel 15<\/h3>\r\n        <\/div>\r\n        <div class=\"sd-block-text  marginbottom-40px\r\n        \">\r\n            <p>Deze verantwoordelijkheden vloeien voort uit Artikel 15 van de MDR en IVDR. Biotop ondersteunt u op het gebied van de PRRC-rol, uw <a href=\"https:\/\/www.biotopmedical.nl\/nl\/technische-documentatie\/\">technische documentatie<\/a> en uw <a href=\"\/quality-management-systems\/\">kwaliteitsmanagementsysteem<\/a>, zodat deze onderdelen op elkaar aansluiten in plaats van los van elkaar te worden behandeld.<\/p>\n\r\n        <\/div>[\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column width=&#8221;1\/4&#8243; col_color=&#8221;bg_lightpurple&#8221; el_class=&#8221;left-sidebar&#8221;]\r\n        <div class=\"sd-block-menu  marginbottom-40px\r\n        \">\r\n        <div class=\"sd-block-title  align-left\">\r\n            <h3 class=\"sd-block-title-htag  marginbottom-0px align-left color-black\r\n            \">Services<\/h3>\r\n        <\/div><ul><li class=\"menu-item\">\r\n                    <a href=\"https:\/\/www.biotopmedical.nl\/quality-management-system\/\">Quality Management System<span class=\"expand\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 256 512\"><path fill=\"currentColor\" d=\"M64 448c-8.188 0-16.38-3.125-22.62-9.375c-12.5-12.5-12.5-32.75 0-45.25L178.8 256L41.38 118.6c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l160 160c12.5 12.5 12.5 32.75 0 45.25l-160 160C80.38 444.9 72.19 448 64 448z\"\/><\/svg><\/span><\/a><ul class=\"sub-menu\"><li class=\"sub-menu-item\">\r\n                                <a href=\"https:\/\/www.biotopmedical.nl\/?page_id=65\">QMS Implementation<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 256 512\"><path fill=\"currentColor\" d=\"M64 448c-8.188 0-16.38-3.125-22.62-9.375c-12.5-12.5-12.5-32.75 0-45.25L178.8 256L41.38 118.6c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l160 160c12.5 12.5 12.5 32.75 0 45.25l-160 160C80.38 444.9 72.19 448 64 448z\"\/><\/svg><\/a>\r\n                            <\/li><li class=\"sub-menu-item\">\r\n                                <a href=\"https:\/\/www.biotopmedical.nl\/quality-management-system\/medical-device-auditing\/\">Medical device auditing<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 256 512\"><path fill=\"currentColor\" d=\"M64 448c-8.188 0-16.38-3.125-22.62-9.375c-12.5-12.5-12.5-32.75 0-45.25L178.8 256L41.38 118.6c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l160 160c12.5 12.5 12.5 32.75 0 45.25l-160 160C80.38 444.9 72.19 448 64 448z\"\/><\/svg><\/a>\r\n                            <\/li><\/ul><\/li><li class=\"menu-item\">\r\n                    <a href=\"https:\/\/www.biotopmedical.nl\/technical-documentation\/\">Technical Documentation File<span class=\"expand\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 256 512\"><path fill=\"currentColor\" d=\"M64 448c-8.188 0-16.38-3.125-22.62-9.375c-12.5-12.5-12.5-32.75 0-45.25L178.8 256L41.38 118.6c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l160 160c12.5 12.5 12.5 32.75 0 45.25l-160 160C80.38 444.9 72.19 448 64 448z\"\/><\/svg><\/span><\/a><ul class=\"sub-menu\"><li class=\"sub-menu-item\">\r\n                                <a href=\"https:\/\/www.biotopmedical.nl\/technical-documentation\/medical-device-risk-management\/\">Medical device risk management<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 256 512\"><path fill=\"currentColor\" d=\"M64 448c-8.188 0-16.38-3.125-22.62-9.375c-12.5-12.5-12.5-32.75 0-45.25L178.8 256L41.38 118.6c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l160 160c12.5 12.5 12.5 32.75 0 45.25l-160 160C80.38 444.9 72.19 448 64 448z\"\/><\/svg><\/a>\r\n                            <\/li><li class=\"sub-menu-item\">\r\n                                <a href=\"https:\/\/www.biotopmedical.nl\/technical-documentation\/clinical-evaluation-mdr\/\">Clinical Evaluation &#038; MDR<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 256 512\"><path fill=\"currentColor\" d=\"M64 448c-8.188 0-16.38-3.125-22.62-9.375c-12.5-12.5-12.5-32.75 0-45.25L178.8 256L41.38 118.6c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l160 160c12.5 12.5 12.5 32.75 0 45.25l-160 160C80.38 444.9 72.19 448 64 448z\"\/><\/svg><\/a>\r\n                            <\/li><li class=\"sub-menu-item\">\r\n                                <a href=\"https:\/\/www.biotopmedical.nl\/technical-documentation\/systematic-literature-searches\/\">Systematic Literature Searches<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 256 512\"><path fill=\"currentColor\" d=\"M64 448c-8.188 0-16.38-3.125-22.62-9.375c-12.5-12.5-12.5-32.75 0-45.25L178.8 256L41.38 118.6c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l160 160c12.5 12.5 12.5 32.75 0 45.25l-160 160C80.38 444.9 72.19 448 64 448z\"\/><\/svg><\/a>\r\n                            <\/li><li class=\"sub-menu-item\">\r\n                                <a href=\"https:\/\/www.biotopmedical.nl\/technical-documentation\/biological-safety-assessment\/\">Biological Evaluation<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 256 512\"><path fill=\"currentColor\" d=\"M64 448c-8.188 0-16.38-3.125-22.62-9.375c-12.5-12.5-12.5-32.75 0-45.25L178.8 256L41.38 118.6c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l160 160c12.5 12.5 12.5 32.75 0 45.25l-160 160C80.38 444.9 72.19 448 64 448z\"\/><\/svg><\/a>\r\n                            <\/li><li class=\"sub-menu-item\">\r\n                                <a href=\"https:\/\/www.biotopmedical.nl\/technical-documentation\/other\/\">Other<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 256 512\"><path fill=\"currentColor\" d=\"M64 448c-8.188 0-16.38-3.125-22.62-9.375c-12.5-12.5-12.5-32.75 0-45.25L178.8 256L41.38 118.6c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l160 160c12.5 12.5 12.5 32.75 0 45.25l-160 160C80.38 444.9 72.19 448 64 448z\"\/><\/svg><\/a>\r\n                            <\/li><\/ul><\/li><li class=\"menu-item\">\r\n                    <a href=\"https:\/\/www.biotopmedical.nl\/person-responsible-for-regulatory-compliance\/\">Person Responsible for Regulatory Compliance<span class=\"expand\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 256 512\"><path fill=\"currentColor\" d=\"M64 448c-8.188 0-16.38-3.125-22.62-9.375c-12.5-12.5-12.5-32.75 0-45.25L178.8 256L41.38 118.6c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l160 160c12.5 12.5 12.5 32.75 0 45.25l-160 160C80.38 444.9 72.19 448 64 448z\"\/><\/svg><\/span><\/a><\/li><\/ul>\r\n        <\/div>\r\n        <div class=\"sd-block-image  align-center marginbottom-40px\r\n        \"><img decoding=\"async\" title=\"\" alt=\"\" src=\"https:\/\/www.biotopmedical.nl\/wp-content\/uploads\/2022\/09\/Logo_BioTop.svg\" width=\"600\" height=\"500\">\r\n        <\/div>[vc_row_inner][vc_column_inner col_color=&#8221;bg_white&#8221;]\r\n        <div class=\"sd-block-text  marginbottom-0px color-black\r\n        \">\r\n            <p>Voor direct contact bel<br \/>\n+31 (0)71 528 01 12<br \/>\nVragen? Neem contact op<br \/>\ninfo@biotopmedical.nl<\/p>\n\r\n        <\/div>[\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; equal_height=&#8221;yes&#8221; css=&#8221;.vc_custom_1786455533992{padding-top: 0px !important;padding-bottom: 0px !important;}&#8221; el_class=&#8221;sidebar-row&#8221; el_id=&#8221;contact&#8221;][vc_column width=&#8221;3\/4&#8243; css=&#8221;.vc_custom_1745843610440{margin-top: 80px !important;}&#8221;][vc_row_inner][vc_column_inner width=&#8221;7\/12&#8243;]\r\n        <div class=\"sd-block-title  align-left\">\r\n            <h3 class=\"sd-block-title-htag  marginbottom-20px align-left color-white bg bg-purple font-small\r\n            \">Neem contact op!<\/h3>\r\n        <\/div>\n<div class=\"wpcf7 no-js\" id=\"wpcf7-f10-o1\" lang=\"en-US\" dir=\"ltr\" data-wpcf7-id=\"10\">\n<div class=\"screen-reader-response\"><p role=\"status\" aria-live=\"polite\" aria-atomic=\"true\"><\/p> <ul><\/ul><\/div>\n<form 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size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Name *\" value=\"\" type=\"text\" name=\"firstName\" \/><\/span>\n\t\t\t<\/p>\n\t\t<\/div>\n\t\t<div class=\"input input-col-60\">\n\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"companyName\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Company name *\" value=\"\" type=\"text\" name=\"companyName\" \/><\/span>\n\t\t\t<\/p>\n\t\t<\/div>\n\t<\/div>\n\t<div class=\"input-row\">\n\t\t<div class=\"input input-col-60\">\n\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"email\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-email wpcf7-validates-as-required wpcf7-text wpcf7-validates-as-email\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Email*\" value=\"\" type=\"email\" name=\"email\" \/><\/span>\n\t\t\t<\/p>\n\t\t<\/div>\n\t\t<div class=\"input input-col-60\">\n\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"tel\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-tel wpcf7-text wpcf7-validates-as-tel\" aria-invalid=\"false\" placeholder=\"Phone\" value=\"\" type=\"tel\" name=\"tel\" \/><\/span>\n\t\t\t<\/p>\n\t\t<\/div>\n\t<\/div>\n\t<div class=\"input-row\">\n\t\t<div class=\"input-col-120\">\n\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"message\"><textarea cols=\"40\" rows=\"10\" maxlength=\"2000\" class=\"wpcf7-form-control wpcf7-textarea wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Please let us know your question *\" name=\"message\"><\/textarea><\/span>\n\t\t\t<\/p>\n\t\t<\/div>\n\t<\/div>\n\t<div class=\"input-row\">\n\t\t<div class=\"input-col-120\">\n\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"checkbox-922\"><span class=\"wpcf7-form-control wpcf7-checkbox wpcf7-validates-as-required\"><span class=\"wpcf7-list-item first last\"><label><input type=\"checkbox\" name=\"checkbox-922[]\" value=\"Yes, I agree to the\" \/><span class=\"wpcf7-list-item-label\">Yes, I agree to the<\/span><\/label><\/span><\/span><\/span><span class=\"privacy-acceptance-link\"><a href=\"\/privacy-policy\/\" target=\"_blank\"> privacy statement<\/a><\/span>\n\t\t\t<\/p>\n\t\t<\/div>\n\t<\/div>\n\t<div class=\"input-row\">\n\t\t<p><button type=\"submit\" class=\"has-spinner\">Send<\/button>\n\t\t<\/p>\n\t<\/div>\n<\/div>\r\n        <div class=\"SD-col SD-col-60 sd-hidden\">\r\n            <label for=\"apply_form_email_address_2_value\" class=\"SD-label \">Confirm email address<\/label>\r\n            <input type=\"text\" name=\"email_address_2_value\" id=\"apply_form_email_address_2_value\" class=\"SD-input  email_address_2_value\" placeholder=\"\" value=\"\" style=\"display: none;\">\r\n        <\/div>\r\n        \r\n        <div class=\"SD-col SD-col-60 sd-hidden\">\r\n            <label for=\"apply_form_additional_comments_value\" class=\"SD-label \">Additional comments<\/label>\r\n            <textarea name=\"additional_comments_value\" id=\"apply_form_additional_comments_value\" class=\"SD-input  additional_comments_value\" style=\"display: none;\" placeholder=\"\">Please fill in your additional comments<\/textarea>\r\n        <\/div>\r\n    \r\n        <div class=\"SD-col SD-col-60 sd-hidden\">\r\n            <label for=\"apply_form_city_home_value\" class=\"SD-label \">City<\/label>\r\n            <input type=\"hidden\" name=\"city_home_value\" id=\"apply_form_city_home_value\" class=\"SD-input  city_home_value\" placeholder=\"\" value=\"\">\r\n        <\/div>\r\n    \r\n        <div class=\"SD-col SD-col-60 sd-hidden\">\r\n            <label for=\"apply_form_more_additional_comments_value\" class=\"SD-label \">More additional comments<\/label>\r\n            <input type=\"hidden\" name=\"more_additional_comments_value\" id=\"apply_form_more_additional_comments_value\" class=\"SD-input  more_additional_comments_value\" placeholder=\"\" value=\"Please fill in your additional comments\">\r\n        <\/div><div class=\"wpcf7-response-output\" aria-hidden=\"true\"><\/div>\n<\/form>\n<\/div>\n[\/vc_column_inner][vc_column_inner width=&#8221;1\/12&#8243;][\/vc_column_inner][vc_column_inner width=&#8221;1\/3&#8243;]\r\n        <div class=\"sd-block-title  align-left\">\r\n            <h3 class=\"sd-block-title-htag  marginbottom-20px align-left color-white bg bg-purple font-small\r\n            \">Waarom BioTop Medical?<\/h3>\r\n        <\/div>\r\n        <div class=\"sd-block-usp  marginbottom-20px\r\n        \">\r\n            <div class=\"usp-inner\">\r\n                <div class=\"usp-icon\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 448 512\"><path fill=\"currentColor\" d=\"M438.6 105.4C451.1 117.9 451.1 138.1 438.6 150.6L182.6 406.6C170.1 419.1 149.9 419.1 137.4 406.6L9.372 278.6C-3.124 266.1-3.124 245.9 9.372 233.4C21.87 220.9 42.13 220.9 54.63 233.4L159.1 338.7L393.4 105.4C405.9 92.88 426.1 92.88 438.6 105.4H438.6z\"\/><\/svg><\/div>\r\n                <div class=\"usp-text\">Getrainde en ervaren PRRC-specialisten die u hands-on ondersteunen.<\/div>\r\n            <\/div>\r\n        <\/div>\r\n        <div class=\"sd-block-title  align-left\">\r\n            <h3 class=\"sd-block-title-htag  marginbottom-20px align-left color-white bg bg-purple font-small\r\n            \">Vragen? Neem contact op<\/h3>\r\n        <\/div>\r\n        <div class=\"sd-block-text  marginbottom-0px color-black\r\n        \">\r\n            <p>Voor direct contact bel<br \/>\n+31 (0)71 528 01 12<br \/>\nU kunt ons ook mailen<br \/>\ninfo@biotopmedical.nl<\/p>\n\r\n        <\/div>[\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column width=&#8221;1\/4&#8243;][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; equal_height=&#8221;yes&#8221; bg_color=&#8221;bg_lightpurple&#8221; css=&#8221;.vc_custom_1745844621633{padding-top: 0px !important;padding-bottom: 0px !important;}&#8221; el_class=&#8221;sidebar-row&#8221;][vc_column width=&#8221;3\/4&#8243; css=&#8221;.vc_custom_1745843610440{margin-top: 80px !important;}&#8221;]\r\n        <div class=\"sd-block-title  align-left\">\r\n            <h2 class=\"sd-block-title-htag  marginbottom-20px align-left color-white bg bg-purple font-small\r\n            \">Veelgestelde vragen over de PRRC-rol<\/h2>\r\n        <\/div>[vc_row_inner][vc_column_inner width=&#8221;1\/2&#8243;]\r\n        <div class=\"sd-block-faq  marginbottom-40px\">\r\n            <div class=\"faq-inner \">\r\n                <div class=\"faq-title\">\r\n                    \r\n        <div class=\"sd-block-title  align-left\">\r\n            <h3 class=\"sd-block-title-htag  marginbottom-0px align-left color-white\r\n            \">Wat is een PRRC?<\/h3>\r\n        <\/div>\r\n                    <div class=\"icon-container\">\r\n                        <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 14 14\"><path fill=\"currentColor\" d=\"M6,8H0V6h6V0h2v6h6v2H8v6H6V8z\"\/><\/svg>\r\n                    <\/div>\r\n                <\/div>\r\n                <div class=\"faq-content\">\r\n                    \r\n        <div class=\"sd-block-text  marginbottom-0px\r\n        \">\r\n            <p>Een PRRC (Person Responsible for Regulatory Compliance) is de persoon die een fabrikant van medische hulpmiddelen of IVD&#8217;s moet aanstellen onder Artikel 15 van de MDR en IVDR. Deze persoon is verantwoordelijk voor het waarborgen dat uw technische documentatie, conformiteitsbeoordeling, post-market surveillance en meldplichten daadwerkelijk aan de regelgeving voldoen.<\/p>\n\r\n        <\/div>\r\n                <\/div>\r\n            <\/div>\r\n        <\/div>\r\n        <div class=\"sd-block-faq  marginbottom-40px\">\r\n            <div class=\"faq-inner \">\r\n                <div class=\"faq-title\">\r\n                    \r\n        <div class=\"sd-block-title  align-left\">\r\n            <h3 class=\"sd-block-title-htag  marginbottom-0px align-left color-white\r\n            \">Wat zijn de eisen voor een PRRC?<\/h3>\r\n        <\/div>\r\n                    <div class=\"icon-container\">\r\n                        <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 14 14\"><path fill=\"currentColor\" d=\"M6,8H0V6h6V0h2v6h6v2H8v6H6V8z\"\/><\/svg>\r\n                    <\/div>\r\n                <\/div>\r\n                <div class=\"faq-content\">\r\n                    \r\n        <div class=\"sd-block-text  marginbottom-0px\r\n        \">\r\n            <p>Artikel 15 vraagt om een relevant diploma, zoals rechten, geneeskunde, farmacie of techniek, gecombineerd met een jaar praktijkervaring met medische hulpmiddelen of kwaliteitsmanagementsystemen. Zonder passend diploma volstaan ook vier jaar beroepservaring in regulatory affairs of QMS voor medische hulpmiddelen.<\/p>\n\r\n        <\/div>\r\n                <\/div>\r\n            <\/div>\r\n        <\/div>\r\n        <div class=\"sd-block-faq  marginbottom-40px\">\r\n            <div class=\"faq-inner \">\r\n                <div class=\"faq-title\">\r\n                    \r\n        <div class=\"sd-block-title  align-left\">\r\n            <h3 class=\"sd-block-title-htag  marginbottom-0px align-left color-white\r\n            \">Kan \u00e9\u00e9n PRRC voor meerdere fabrikanten werken?<\/h3>\r\n        <\/div>\r\n                    <div class=\"icon-container\">\r\n                        <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 14 14\"><path fill=\"currentColor\" d=\"M6,8H0V6h6V0h2v6h6v2H8v6H6V8z\"\/><\/svg>\r\n                    <\/div>\r\n                <\/div>\r\n                <div class=\"faq-content\">\r\n                    \r\n        <div class=\"sd-block-text  marginbottom-0px\r\n        \">\r\n            <p>Ja, een externe PRRC zoals Biotop Medical kan de rol voor meerdere fabrikanten tegelijk vervullen, zolang de verantwoordelijkheden voor elke fabrikant daadwerkelijk waargemaakt kunnen worden.<\/p>\n\r\n        <\/div>\r\n                <\/div>\r\n            <\/div>\r\n        <\/div>\r\n        <div class=\"sd-block-faq  marginbottom-40px\">\r\n            <div class=\"faq-inner \">\r\n                <div class=\"faq-title\">\r\n                    \r\n        <div class=\"sd-block-title  align-left\">\r\n            <h3 class=\"sd-block-title-htag  marginbottom-0px align-left color-white\r\n            \">Hebben onze fabrikant en onze EU-gemachtigde een aparte PRRC nodig, of kan \u00e9\u00e9n PRRC beide dekken?<\/h3>\r\n        <\/div>\r\n                    <div class=\"icon-container\">\r\n                        <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 14 14\"><path fill=\"currentColor\" d=\"M6,8H0V6h6V0h2v6h6v2H8v6H6V8z\"\/><\/svg>\r\n                    <\/div>\r\n                <\/div>\r\n                <div class=\"faq-content\">\r\n                    \r\n        <div class=\"sd-block-text  marginbottom-0px\r\n        \">\r\n            <p>Een fabrikant en zijn EU-gemachtigde hebben elk een eigen PRRC nodig, de twee rollen kunnen niet door dezelfde persoon worden vervuld. Biotop kan de PRRC-rol voor beide partijen op zich nemen, of voor beide tegelijk via verschillende teamleden, zodat aan de eis voor beide zijden wordt voldaan zonder dat u dit zelf hoeft te co\u00f6rdineren.<\/p>\n\r\n        <\/div>\r\n                <\/div>\r\n            <\/div>\r\n        <\/div>[\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;]\r\n        <div class=\"sd-block-faq  marginbottom-40px\">\r\n            <div class=\"faq-inner \">\r\n                <div class=\"faq-title\">\r\n                    \r\n        <div class=\"sd-block-title  align-left\">\r\n            <h3 class=\"sd-block-title-htag  marginbottom-0px align-left color-white\r\n            \">Wat is Artikel 15?<\/h3>\r\n        <\/div>\r\n                    <div class=\"icon-container\">\r\n                        <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 14 14\"><path fill=\"currentColor\" d=\"M6,8H0V6h6V0h2v6h6v2H8v6H6V8z\"\/><\/svg>\r\n                    <\/div>\r\n                <\/div>\r\n                <div class=\"faq-content\">\r\n                    \r\n        <div class=\"sd-block-text  marginbottom-0px\r\n        \">\r\n            <p>Artikel 15 is het artikel in de MDR en IVDR waarin de PRRC-verplichting zelf wordt ge\u00efntroduceerd. Het bepaalt wie een PRRC nodig heeft, aan welke kwalificaties deze moet voldoen, en waar deze verantwoordelijk voor is. Het bevat ook de uitzondering waarmee fabrikanten met minder dan 50 medewerkers een externe PRRC kunnen aanstellen.<\/p>\n\r\n        <\/div>\r\n                <\/div>\r\n            <\/div>\r\n        <\/div>\r\n        <div class=\"sd-block-faq  marginbottom-40px\">\r\n            <div class=\"faq-inner \">\r\n                <div class=\"faq-title\">\r\n                    \r\n        <div class=\"sd-block-title  align-left\">\r\n            <h3 class=\"sd-block-title-htag  marginbottom-0px align-left color-white\r\n            \">Moet een PRRC geregistreerd worden in EUDAMED?<\/h3>\r\n        <\/div>\r\n                    <div class=\"icon-container\">\r\n                        <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 14 14\"><path fill=\"currentColor\" d=\"M6,8H0V6h6V0h2v6h6v2H8v6H6V8z\"\/><\/svg>\r\n                    <\/div>\r\n                <\/div>\r\n                <div class=\"faq-content\">\r\n                    \r\n        <div class=\"sd-block-text  marginbottom-0px\r\n        \">\r\n            <p>Ja, de gegevens van de PRRC moeten geregistreerd worden als onderdeel van uw fabrikantenregistratie in EUDAMED, de EU-database voor medische hulpmiddelen.<\/p>\n\r\n        <\/div>\r\n                <\/div>\r\n            <\/div>\r\n        <\/div>\r\n        <div class=\"sd-block-faq  marginbottom-40px\">\r\n            <div class=\"faq-inner \">\r\n                <div class=\"faq-title\">\r\n                    \r\n        <div class=\"sd-block-title  align-left\">\r\n            <h3 class=\"sd-block-title-htag  marginbottom-0px align-left color-white\r\n            \">Is een PRRC verplicht onder zowel de MDR als de IVDR?<\/h3>\r\n        <\/div>\r\n                    <div class=\"icon-container\">\r\n                        <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 14 14\"><path fill=\"currentColor\" d=\"M6,8H0V6h6V0h2v6h6v2H8v6H6V8z\"\/><\/svg>\r\n                    <\/div>\r\n                <\/div>\r\n                <div class=\"faq-content\">\r\n                    \r\n        <div class=\"sd-block-text  marginbottom-0px\r\n        \">\r\n            <p>Ja. Zowel de Medical Device Regulation als de In Vitro Diagnostic Regulation bevatten de PRRC-verplichting in hun Artikel 15, dus fabrikanten onder beide verordeningen hebben er een nodig.<\/p>\n\r\n        <\/div>\r\n                <\/div>\r\n            <\/div>\r\n        <\/div>\r\n        <div class=\"sd-block-faq  marginbottom-40px\">\r\n            <div class=\"faq-inner \">\r\n                <div class=\"faq-title\">\r\n                    \r\n        <div class=\"sd-block-title  align-left\">\r\n            <h3 class=\"sd-block-title-htag  marginbottom-0px align-left color-white\r\n            \">Hoe voldoet Biotop aan de eis dat de PRRC 'permanent en continu beschikbaar' moet zijn?<\/h3>\r\n        <\/div>\r\n                    <div class=\"icon-container\">\r\n                        <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 14 14\"><path fill=\"currentColor\" d=\"M6,8H0V6h6V0h2v6h6v2H8v6H6V8z\"\/><\/svg>\r\n                    <\/div>\r\n                <\/div>\r\n                <div class=\"faq-content\">\r\n                    \r\n        <div class=\"sd-block-text  marginbottom-0px\r\n        \">\r\n            <p>Artikel 15 vereist dat fabrikanten zonder eigen PRRC er permanent en continu een beschikbaar hebben. E\u00e9n externe consultant kan dit lastig garanderen tijdens vakantie of afwezigheid. Het PRRC-team van Biotop deelt de kennis over uw dossiers, zodat aan deze beschikbaarheidseis wordt voldaan door de opzet zelf, niet door afhankelijk te zijn van de agenda van \u00e9\u00e9n persoon.<\/p>\n\r\n        <\/div>\r\n                <\/div>\r\n            <\/div>\r\n        <\/div>[\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column width=&#8221;1\/4&#8243; col_color=&#8221;bg_lightpurple&#8221; el_class=&#8221;left-sidebar&#8221;][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row full_width=&#8221;stretch_row&#8221; content_placement=&#8221;bottom&#8221; bg_color=&#8221;bg_purple&#8221; bg_fade=&#8221;fade_white&#8221; css=&#8221;.vc_custom_1670580737571{background-image: url(https:\/\/www.biotopmedical.nl\/wp-content\/uploads\/2022\/11\/home_banner.jpg?id=505) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}&#8221;][vc_column width=&#8221;7\/12&#8243;][\/vc_column][vc_column css_animation=&#8221;fadeInUp&#8221; width=&#8221;5\/12&#8243;][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; equal_height=&#8221;yes&#8221; css=&#8221;.vc_custom_1662038703013{padding-top: 0px !important;padding-bottom: 0px !important;}&#8221; el_class=&#8221;sidebar-row&#8221;][vc_column width=&#8221;3\/4&#8243; css=&#8221;.vc_custom_1745843610440{margin-top: 80px !important;}&#8221;][vc_row_inner][vc_column_inner width=&#8221;1\/2&#8243;][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner width=&#8221;1\/2&#8243;][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner width=&#8221;1\/2&#8243;][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column width=&#8221;1\/4&#8243; col_color=&#8221;bg_lightpurple&#8221; el_class=&#8221;left-sidebar&#8221;][vc_row_inner][vc_column_inner col_color=&#8221;bg_white&#8221;][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row&#8221; equal_height=&#8221;yes&#8221; css=&#8221;.vc_custom_1786455533992{padding-top: 0px !important;padding-bottom: 0px !important;}&#8221; el_class=&#8221;sidebar-row&#8221; el_id=&#8221;contact&#8221;][vc_column width=&#8221;3\/4&#8243; css=&#8221;.vc_custom_1745843610440{margin-top: 80px !important;}&#8221;][vc_row_inner][vc_column_inner width=&#8221;7\/12&#8243;][\/vc_column_inner][vc_column_inner width=&#8221;1\/12&#8243;][\/vc_column_inner][vc_column_inner width=&#8221;1\/3&#8243;][\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.biotopmedical.nl\/nl\/person-responsible-for-regulatory-compliance\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Person Responsible for Regulatory Compliance&#8221;<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-921","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Person Responsible for Regulatory Compliance | BioTop Medical<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.biotopmedical.nl\/nl\/person-responsible-for-regulatory-compliance\/\" \/>\n<meta property=\"og:locale\" content=\"nl_NL\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Person Responsible for Regulatory Compliance | BioTop Medical\" \/>\n<meta property=\"og:description\" content=\"[vc_row full_width=&#8221;stretch_row&#8221; 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