{"id":8346,"date":"2021-10-11T19:57:32","date_gmt":"2021-10-11T17:57:32","guid":{"rendered":"https:\/\/www.medicoforum.com\/pmcf-post-market-clinical-follow-up\/"},"modified":"2024-05-17T15:39:12","modified_gmt":"2024-05-17T13:39:12","slug":"pmcf-post-market-clinical-follow-up","status":"publish","type":"page","link":"https:\/\/www.medicoforum.com\/en\/pmcf-post-market-clinical-follow-up\/","title":{"rendered":"PMCF (Post Market Clinical Follow Up)"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-bd796f-d0fb62a1ca4db618da335498cbc17266\">\n.avia-section.av-bd796f-d0fb62a1ca4db618da335498cbc17266{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.medicoforum.com\/wp-content\/uploads\/2020\/03\/layerformat_medicoforum_about_02.jpg);\nbackground-position:50% 0%;\nbackground-attachment:fixed;\nmargin-top:0px;\nmargin-bottom:60px;\n}\n.avia-section.av-bd796f-d0fb62a1ca4db618da335498cbc17266 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class=\"av-section-color-overlay\"><\/div><a href='#next-section' title='' class='scroll-down-link av-custom-scroll-down-color avia-svg-icon avia-font-svg_entypo-fontello' data-av_svg_icon='down-open-mini' data-av_iconset='svg_entypo-fontello'><svg version=\"1.1\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"15\" height=\"32\" viewBox=\"0 0 15 32\" preserveAspectRatio=\"xMidYMid meet\" aria-labelledby='av-svg-title-1' aria-describedby='av-svg-desc-1' role=\"graphics-symbol\" aria-hidden=\"true\">\n<title id='av-svg-title-1'>Scroll to next section<\/title>\n<desc id='av-svg-desc-1'>Scroll to next section<\/desc>\n<path d=\"M12.96 12.16q0.704-0.832 1.536 0 0.832 0.704 0 1.536l-6.272 6.144q-0.704 0.704-1.536 0l-6.272-6.144q-0.832-0.832 0-1.536 0.768-0.768 1.6 0l5.44 4.992z\"><\/path>\n<\/svg><\/a><div class='container av-section-cont-open' ><main  role=\"main\" itemprop=\"mainContentOfPage\"  class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-8346'><div class='entry-content-wrapper clearfix'>\n<div  class='flex_column av-9ew7w7-dc837895b7f19a8b868c8a2bb10e614d av_one_third  avia-builder-el-1  el_before_av_two_third  avia-builder-el-first  first flex_column_div  '     ><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-8tldev-7477fe854a43569da6a34da5169a9b8c\">\n.flex_column.av-8tldev-7477fe854a43569da6a34da5169a9b8c{\nborder-radius:0 21px 21px 21px;\npadding:34px 34px 34px 34px;\n}\n<\/style>\n<div  class='flex_column av-8tldev-7477fe854a43569da6a34da5169a9b8c av_two_third  avia-builder-el-2  el_after_av_one_third  avia-builder-el-last  whiteleft flex_column_div  '     ><section  class='av_textblock_section av-ldt3zmyc-9d6d643cba6200ca2a7c77a34ad4e544 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><h1><span class=\"clbold\">PMCF: <\/span>Monitoring under Everyday Conditions with <span class=\"clbold\">Post Market Clinical Follow Up<\/span>.<\/h1>\n<\/div><\/section><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-4wb7k7-6e210fbbd59127907a22efbb79467c19\">\n#top .hr.av-4wb7k7-6e210fbbd59127907a22efbb79467c19{\nmargin-top:10px;\nmargin-bottom:10px;\n}\n.hr.av-4wb7k7-6e210fbbd59127907a22efbb79467c19 .hr-inner{\nwidth:50px;\nborder-color:#000000;\n}\n<\/style>\n<div  class='hr av-4wb7k7-6e210fbbd59127907a22efbb79467c19 hr-custom  avia-builder-el-4  el_after_av_textblock  el_before_av_iconlist  hr-left hr-icon-no'><span class='hr-inner inner-border-av-border-fat'><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<div  class='avia-icon-list-container av-lvs35cr1-b6b7cea3d6a2a5f018700275c7f58373  avia-builder-el-5  el_after_av_hr  el_before_av_button  boxtype02'><ul class='avia-icon-list avia_animate_when_almost_visible avia-icon-list-left av-iconlist-small av-lvs35cr1-b6b7cea3d6a2a5f018700275c7f58373'>\n<li><div class='iconlist_icon av-lvs343b2-b430f2a57e001283794216f3226a49f9 avia-font-medicoforum_icon avia-iconfont avia-font-medicoforum_icon'><span class='av-icon-char' data-av_icon='\ue900' data-av_iconfont='medicoforum_icon' aria-hidden=\"true\"><\/span><\/div><article class=\"article-icon-entry \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Our services for PMCF include:\"><div class='av_iconlist_title iconlist_title_small  '  itemprop=\"headline\" >Our services for PMCF include:<\/div><\/header><div class='iconlist_content '  itemprop=\"text\" ><ul class=\"medico-list-checked\">\n<li>Development of the strategy for generating clinical data under real application conditions<\/li>\n<li>Advice and support for the successful implementation of PMCF activities<\/li>\n<li>Creation of PMCF processes, plans and reports<\/li>\n<li>Support with case number planning and evaluation of PMCF data<\/li>\n<li>Conducting PMCF studies, e.g. long-term observations of patients and studies on known risks from the literature<\/li>\n<li>Observational studies (data collection under routine conditions)<\/li>\n<li>Retrospective evaluation of existing user data<\/li>\n<li>Monitoring the scientific literature<\/li>\n<li>Evaluations of other PMS activities<\/li>\n<\/ul>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<\/ul><\/div><br \/>\n<div  class='avia-button-wrap av-2wgj4h-02d4749ecb65f21f05cf441775f1771d-wrap avia-button-center  avia-builder-el-6  el_after_av_iconlist  el_before_av_hr  diamond'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2wgj4h-02d4749ecb65f21f05cf441775f1771d\">\n#top #wrap_all .avia-button.av-2wgj4h-02d4749ecb65f21f05cf441775f1771d{\nbackground-color:#edf5f9;\nborder-color:#edf5f9;\ncolor:#666666;\ntransition:all 0.4s ease-in-out;\n}\n#top #wrap_all .avia-button.av-2wgj4h-02d4749ecb65f21f05cf441775f1771d .avia-svg-icon svg:first-child{\nfill:#666666;\nstroke:#666666;\n}\n<\/style>\n<a href='#contactform'  class='avia-button av-2wgj4h-02d4749ecb65f21f05cf441775f1771d av-link-btn avia-icon_select-yes-left-icon avia-size-x-large avia-position-center'   aria-label=\"Get in touch now\"><span class='avia_button_icon avia_button_icon_left avia-iconfont avia-font-medicoforum_icon' data-av_icon='\ue900' data-av_iconfont='medicoforum_icon' ><\/span><span class='avia_iconbox_title' >Get in touch now<\/span><\/a><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2waqsh-4fa2fb16180fa81cf581cb1be2d755f5\">\n#top .hr.av-2waqsh-4fa2fb16180fa81cf581cb1be2d755f5{\nmargin-top:10px;\nmargin-bottom:10px;\n}\n.hr.av-2waqsh-4fa2fb16180fa81cf581cb1be2d755f5 .hr-inner{\nwidth:0;\nborder-color:#000000;\n}\n<\/style>\n<div  class='hr av-2waqsh-4fa2fb16180fa81cf581cb1be2d755f5 hr-custom  avia-builder-el-7  el_after_av_button  el_before_av_textblock  hr-left hr-icon-no'><span class='hr-inner inner-border-av-border-fat'><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<section  class='av_textblock_section av-k7ooakmw-613eaad5cb9fbc26042fa1e57faaf447 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock strongblack'  itemprop=\"text\" ><h3>Clinical follow-up<\/h3>\n<p>An essential and mandatory part of quality management is the post-marketing follow-up of each medical device. A system or clinical follow-up plan must be established and maintained to enable post-market surveillance (PMS).<\/p>\n<p>Since it is often not possible to exclude all risks during the approval process, post-market monitoring under everyday conditions is essential.<\/p>\n<p>Data sources for this monitoring include post-market clinical follow-up (PMCF), internal vigilance systems, and external database searches.<\/p>\n<h3>When PMCF studies become necessary<\/h3>\n<p>Post-market clinical follow-up studies become necessary as soon as a regular market observation does not provide sufficient clinical data, which are required for the mandatory document updates.<\/p>\n<p>The data generated in the Post-Market Clinical Follow Up studies complement the existing clinical data and are thus a subset of the PMS. For example, PMCF studies may be necessary for novel or high-risk products.<\/p>\n<p>These studies proceed according to a predefined Post Market Clinical Follow Up Plan (PMCF Plan). In addition to the observation and evaluation of one&#8217;s own product, evaluations of similar products are used to draw conclusions about one&#8217;s own product. The PMCF Plan is a component of the Post Market Surveillance Plan (PMS Plan).<\/p>\n<p><strong>Medicoforum, together with CRO and sister company <a href=\"https:\/\/mediconomics.com\/\" target=\"_blank\" rel=\"noopener\">Mediconomics<\/a>, is an expert in conducting PMCF studies.<\/strong><\/p>\n<h2>MDR requirements<\/h2>\n<p>The European Medical Devices Regulation (Article 61 Clinical Evaluation, Annex XIV MDR) requires proactive, continuous, objective and thorough documentation and clinical evaluation. The documentation and clinical data generated by the clinical follow-up plan must be updated throughout the life cycle of the medical device.<\/p>\n<h3>Data acquisition<\/h3>\n<p>In this process, corresponding data on quality, safety, usability, justifiability of the risk-benefit ratio and performance are collected in order to identify necessary corrective measures and thus to be able to set appropriate interventions. Furthermore, the MDR requires regular reporting of PMS results and measures in the form of &#8220;safety reports.&#8221;<\/p>\n<h3>Determination of the scope according to the type of product<\/h3>\n<p>The scope and extent of this assessment is closely linked to the classification, intended use, nature and risks of the product in question. For some products, clinical monitoring may not be considered necessary with appropriate justification and documentation.<\/p>\n<h3>Reporting requirements<\/h3>\n<p>Post-market clinical follow-up activities should not only identify unknown side effects and contraindications at an early stage, but also systematically identify incorrect or off-label uses of the product and possibly trigger a re-evaluation of its intended purpose. Safety corrective actions and incidents must be reported to the authorities and investigated promptly.<\/p>\n<h3>How Medicoforum supports you<\/h3>\n<p><strong>Our team of experts supports you as a manufacturer with all PMCF obligations and activities such as development of a PMS plan, PMCF Plan or the execution of your Post Market Clinical Follow Up &#8211; saving you time and unnecessary bureaucracy.<\/strong><\/p>\n<\/div><\/section><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kttrsoeq-f90a0d34935209dbb6c6aff98f9c0005\">\n#top .hr.hr-invisible.av-kttrsoeq-f90a0d34935209dbb6c6aff98f9c0005{\nheight:25px;\n}\n<\/style>\n<div  class='hr av-kttrsoeq-f90a0d34935209dbb6c6aff98f9c0005 hr-invisible  avia-builder-el-9  el_after_av_textblock  avia-builder-el-last '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><\/p><\/div>[av_section min_height='percent' min_height_pc='77' min_height_px='500px' 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sc_version='1.0' admin_preview_bg='']\n<span class=\"h2optisch\">Medicoforum Factsheet<\/span>\n[\/av_textblock]\n\n[av_hr class='custom' height='50' shadow='no-shadow' position='left' custom_border='av-border-fat' custom_width='50px' custom_border_color='#000000' custom_margin_top='10px' custom_margin_bottom='10px' icon_select='no' custom_icon_color='' icon='ue808' font='entypo-fontello' av_uid='av-dvkk5w']\n\n[av_textblock textblock_styling_align='' textblock_styling='' textblock_styling_gap='' textblock_styling_mobile='' size='' av-desktop-font-size='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' font_color='' color='' id='' custom_class='hoehe_contact_bild' template_class='' av_uid='av-ktea9a10' sc_version='1.0' admin_preview_bg='']\n<img decoding=\"async\" class=\"wp-image-1191 alignleft\" src=\"https:\/\/www.medicoforum.com\/wp-content\/uploads\/2020\/04\/Medicoforum_building.jpg\" alt=\"Medicoforum Building Hannover\" width=\"490\" height=\"272\">\n[\/av_textblock]\n\n[av_hr class='custom' icon_select='no' icon='ue808' font='entypo-fontello' position='left' shadow='no-shadow' height='50' custom_border='av-border-none' custom_width='50px' custom_margin_top='15px' custom_margin_bottom='0px' custom_border_color='#000000' custom_icon_color='' id='' custom_class='' template_class='' av_uid='av-2tkxoc' sc_version='1.0' admin_preview_bg='']\n\n[av_textblock fold_type='' fold_height='' fold_more='Weiterlesen' fold_less='Read less' fold_text_style='' fold_btn_align='' textblock_styling_align='' textblock_styling='' textblock_styling_gap='' textblock_styling_mobile='' size='' av-desktop-font-size='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' font_color='' color='' fold_overlay_color='' fold_text_color='' fold_btn_color='theme-color' fold_btn_bg_color='' fold_btn_font_color='' size-btn-text='' av-desktop-font-size-btn-text='' av-medium-font-size-btn-text='' av-small-font-size-btn-text='' av-mini-font-size-btn-text='' fold_timer='' z_index_fold='' id='' custom_class='' template_class='' av_uid='av-ks0k1swi' sc_version='1.0' admin_preview_bg='']\n<span class=\"clbold\">Our focus:<\/span> MDR consulting and services for medical devices such as quality management, risk management, clinical data and studies or clinical evaluation. <span class=\"clbold\">Project overview:<\/span> 45+ medical device projects (from idea to product) 120+ dossiers 20+ patents <span class=\"clbold\">Competence status<\/span> Certified according to DIN EN ISO 13485:2016, Medical Device Regulation (MDR), Medical Device Law Implementation Act (MPDG), expert knowledge in GCP and GMP as well as ISO 14155 and always up-to-date specialist knowledge. <span class=\"clbold\">About the company:<\/span> Founded in 2003 10+ in-house specialists a large number of satisfied customers <span class=\"clbold\">Project partners:<\/span> Mediconomics GmbH (Europe\/USA\/Canada) DNV MedCert GmbH 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