{"id":55867,"date":"2025-11-18T12:08:35","date_gmt":"2025-11-18T11:08:35","guid":{"rendered":"https:\/\/clariscience.com\/servizi-clariscience\/regulatory-affairs\/pmcf-service"},"modified":"2026-05-18T14:36:00","modified_gmt":"2026-05-18T12:36:00","slug":"pmcf-service","status":"publish","type":"servizi-clariscience","link":"https:\/\/clariscience.com\/en\/services\/regulatory-affairs\/pmcf-service","title":{"rendered":"PMCF"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"55867\" class=\"elementor elementor-55867 elementor-55803\" data-elementor-post-type=\"servizi-clariscience\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-92d99b4 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"92d99b4\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-bd61d65\" data-id=\"bd61d65\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-00aed92 elementor-widget elementor-widget-text-editor\" data-id=\"00aed92\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h2><strong>Clinical consistency, regulatory compliance, strategic control<\/strong><\/h2><p><strong>Post-Market Clinical Follow-up (PMCF)<\/strong> is an integral part of <strong>Post-Market Surveillance (PMS)<\/strong> and represents the <strong>natural extension of a medical device\u2019s clinical evaluation<\/strong> under the MDR. It\u2019s a proactive, ongoing process built around a clear plan, designed to gather <em>real-world<\/em> clinical data on device use and confirm its safety, performance, and risk-benefit profile over time. <\/p><p>Under MDR, clinical data refers to any information on a device\u2019s safety or performance in human use, consistent with its intended purpose and the manufacturer\u2019s instructions.<br><strong>PMCF is therefore not merely data collection: it is the process that ensures consistency, updates, and control over clinical documentation<\/strong>.<\/p><h3><strong>Why invest in PMCF<\/strong><\/h3><p>The PMCF plan and report, along with related activities, are a regulatory requirement introduced by the MDR. A robust PMCF framework goes far beyond meeting MDR requirements\u2014it enables you to: <\/p><ul><li><strong>Collect clinical evidence<\/strong> strategically to reinforce and sustain the clinical evaluation<\/li><li><strong>Demonstrate continuous compliance<\/strong> with MDR requirements<\/li><li><strong>Detect emerging risks early and proactively<\/strong><\/li><li><strong>Ensure alignment<\/strong> between clinical evaluation, risk management and PMS<\/li><li><strong>Prevent the most frequent Non-Conformities<\/strong> identified by Notified Bodies<\/li><\/ul><h3><strong>How our service works<\/strong><\/h3><p>Clariscience provides a <strong>PMCF service that is flexible, modular, and fully customizable<\/strong>, designed to align with the manufacturer\u2019s specific regulatory and business needs.<\/p><p><strong>Whether you require end-to-end management or support for selected phases<\/strong>, we adapt to your internal resources and strategic objectives to ensure compliance and efficiency.<\/p><h4><strong>PMCF plan<\/strong><\/h4><ul><li>Analysis of existing clinical documentation<\/li><li>Support in defining activities to include (clinical studies, surveys, literature reviews)<\/li><li>Preparation of the plan in full compliance with MDR and MDCG 2020-7 guidance<\/li><\/ul><h4><strong>PMCF report<\/strong><\/h4><ul><li>Analysis of data collected through the PMCF activities defined in the manufacturer\u2019s plan<\/li><li>Conducting literature reviews and\/or additional research as outlined in the PMCF plan<\/li><li>Preparation of the report in full compliance with MDR requirements and MDCG 2020-8 guidance<\/li><li>Assessment of the impact of findings on technical documentation, including actionable recommendations for updating the clinical evaluation and related documents<\/li><\/ul><h3><strong>Related and integrable activities<\/strong><\/h3><ul><li><strong>Support in designing, planning, and conducting proactive PMCF activities<\/strong>: preparation of documentation for clinical studies (learn more about this service), development and design of surveys or questionnaires (see our service <a href=\"https:\/\/clariscience.com\/en\/services\/regulatory-affairs\/survey-evidence-builder\" target=\"_blank\" rel=\"noopener\">Survey Evidence Builder<\/a>), execution of literature searches<\/li><li><strong>Dataset creation and statistical analysis<\/strong> of data collected through planned PMCF activities<\/li><\/ul><ul><li><strong>Assistance in resolving any<\/strong> <strong>Non-Conformities<\/strong> raised by your Notified Body<\/li><li><strong>Updating the clinical evaluation<\/strong> based on PMCF findings<\/li><li><strong>Delivery of training sessions <\/strong>to enhance internal expertise and autonomy in managing PMCF documentation<\/li><li><strong>Support in defining strategic data collection<\/strong> aimed not only at fulfilling regulatory obligations, but also at <strong>meeting marketing and communication needs<\/strong><\/li><\/ul><h3><strong>Why choose Clariscience<\/strong><\/h3>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-78e55e7 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"78e55e7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Medical writers registered with EMWA and highly experienced in Regulatory Affairs <\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">A multidisciplinary team with proven expertise in the medical sector<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Time and resource savings for your organization<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Guaranteed consistency across all technical documentation <\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Service available for individual phases with a dedicated point of contact<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Greater awareness and engagement of your internal team through interaction with our experts<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-332b2c7 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"332b2c7\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-757cd95\" data-id=\"757cd95\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5eba7d6 elementor-widget elementor-widget-text-editor\" data-id=\"5eba7d6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"MsoNormal\">With us, PMCF is not just a set of obligations to comply with\u2014it becomes <b>a tool to strengthen clinical documentation, prevent non-conformities, and create added value for marketing and communication<\/b>.<\/p><h3 class=\"MsoNormal\"><b>Those who perform PMCF out of obligation remain compliant. Those who do it methodically build value. <\/b><\/h3><p class=\"MsoNormal\">Contact us for a personalized consultation:<strong> info@clariscience.com<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"featured_media":27849,"parent":39611,"template":"","settori-servizi":[560,566],"class_list":["post-55867","servizi-clariscience","type-servizi-clariscience","status-publish","has-post-thumbnail","hentry","settori-servizi-md-en","settori-servizi-xvi-en"],"acf":[],"yoast_head":"<title>PMCF | Clariscience<\/title>\n<meta name=\"description\" content=\"Wondering how to structure your PMCF plan and report? Which PMCF activities should you include to ensure MDR compliance and strengthen your clinical evidence? 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