{"id":55228,"date":"2025-09-16T15:36:09","date_gmt":"2025-09-16T13:36:09","guid":{"rendered":"https:\/\/clariscience.com\/blog\/uncategorized\/survey-pmcf-how-to-collect-post-market-clinical-evidence-effectively-and-in-compliance"},"modified":"2026-04-15T20:20:00","modified_gmt":"2026-04-15T18:20:00","slug":"survey-pmcf-how-to-collect-post-market-clinical-evidence-effectively-and-in-compliance","status":"publish","type":"post","link":"https:\/\/clariscience.com\/en\/blog\/regulatory-affairs\/survey-pmcf-how-to-collect-post-market-clinical-evidence-effectively-and-in-compliance","title":{"rendered":"Survey PMCF: how to collect post-market clinical evidence effectively and in compliance"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"55228\" class=\"elementor elementor-55228 elementor-55223\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-366ffb8 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"366ffb8\" 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-17f8569\" data-id=\"17f8569\" 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-f54d990 elementor-widget elementor-widget-text-editor\" data-id=\"f54d990\" 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>PMCF Surveys: useful tools, to be handled with care<\/strong><\/h2><p>Within the regulatory framework defined by Regulation (EU) 2017\/745, <strong>Post-Market Clinical Follow-up (PMCF)<\/strong> activities play a central role in the lifecycle management of medical devices. Among the methods available for collecting post-market clinical evidence, <strong>surveys<\/strong> stand out for their accessibility, speed, and sustainability. <\/p><p>However, as highlighted in previous contents on this topic (<a href=\"https:\/\/clariscience.com\/en\/blog\/regulatory-affairs\/clinical-data-collection-for-medical-devices-the-role-of-pmcf-surveys\" target=\"_blank\" rel=\"noopener\">here<\/a> you can read one of these), surveys are not without critical issues. Their effectiveness depends on the ability to <strong>design a solid methodological pathway that considers regulatory objectives, target audience, and data quality.<\/strong> <\/p><p>Without these foundations, the risk is to obtain results that are irrelevant or unusable.<\/p><h2><strong>Responding to gaps in Post-Market Clinical data collection<\/strong><\/h2><p>The <strong>Survey Evidence Builder<\/strong> service was born from a <strong>concrete need<\/strong>: many manufacturers must collect post-market clinical evidence but lack adequate tools to do so effectively, compliantly, and sustainably.<\/p><p>In several projects, we observed that <strong>surveys are often considered a \u201csimple\u201d solution yet approached without a real methodological strategy<\/strong>. This leads to results that are of limited utility, difficult to defend in regulatory settings, and sometimes counterproductive. <\/p><p>The <strong>Survey Evidence Builder<\/strong> was developed to fill this gap: a service that <strong>combines regulatory, clinical, and statistical expertise<\/strong> to offer manufacturers <strong>a reliable tool for integrating surveys into their PMCF strategy in a structured and informed way.<\/strong><\/p><h2><strong>When is a PMCF survey useful?<\/strong><\/h2><p>A survey can be <strong>a strategic choice<\/strong> when:<\/p><ul><li><strong>Existing clinical data are insufficient<\/strong> and more evidence is needed to support a claim;<\/li><li>A clinical investigation is ongoing and <strong>complementary evidence is needed<\/strong>;<\/li><li><strong>Data must be collected quickly<\/strong>, but in a structured manner;<\/li><li><strong>Proactive post-market surveillance needs to be demonstrated<\/strong>.<\/li><\/ul><p>In all these cases, a survey can strengthen the clinical evaluation of the device\u2014if designed with care and expertise.<\/p><h2><strong>Why conduct a PMCF survey: benefits and opportunities<\/strong><\/h2><p>When properly designed, <strong>PMCF surveys offer a range of advantages<\/strong> that make them a valuable tool for manufacturers:<\/p><ul><li><strong>Methodological flexibility<\/strong>: adaptable to various clinical and regulatory contexts, and suitable for different targets (clinicians, patients, users).<\/li><li><strong>Speed of execution<\/strong>: faster data collection compared to other PMCF activities, with shorter implementation timelines.<\/li><li><strong>Economic sustainability<\/strong>: less costly than traditional clinical investigations, while maintaining rigor and traceability.<\/li><li><strong>Strategic value<\/strong>: enables the collection of real-world insights that support regulatory decisions, marketing strategies, and product development.<\/li><li><strong>Documented proactivity<\/strong>: demonstrates the manufacturer\u2019s commitment to post-market surveillance, contributing to a robust and updated clinical dossier.<\/li><\/ul><h2><strong>A structured methodological approach<\/strong><\/h2><p>To ensure the validity and defensibility of the data collected, a rigorous methodological approach is essential.<\/p><p>The <strong>Survey Evidence Builder<\/strong> service is structured into four key phases:<\/p><ol><li><h3><strong>Clinical-regulatory context analysis<\/strong><\/h3><\/li><\/ol><p>Review of existing documentation, identification of clinical gaps, and definition of survey objectives aligned with the device\u2019s claims.<\/p><ol start=\"2\"><li><h3><strong>Protocol design<\/strong><\/h3><\/li><\/ol><p>Drafting of a concise yet structured protocol that ensures consistency, traceability, and methodological rigor.<\/p><ol start=\"3\"><li><h3><strong>Statistical analysis plan<\/strong><\/h3><\/li><\/ol><p>Definition of relevant metrics, sample size, and survey structure to ensure data quality and interpretability.<\/p><ol start=\"4\"><li><h3><strong>Questionnaire development<\/strong><\/h3><\/li><\/ol><p>Design of targeted questions based on literature review and regulatory objectives, with attention to clarity and comprehensibility for the selected audience.<\/p><h2><strong>Final considerations<\/strong><\/h2><p>In today\u2019s regulatory landscape, <strong>PMCF surveys can be a useful tool for collecting post-market clinical evidence\u2014provided they are managed with competence and awareness<\/strong>. Methodological design, clear objectives, and data quality are essential elements to transform a survey from a simple opinion-gathering exercise into a source of usable clinical evidence. <\/p><p>For this reason, <strong>each project deserves a careful preliminary assessment<\/strong>, taking into account the specific characteristics of the device and its regulatory context.<\/p><p>\ud83d\udce9 If you would like to explore whether a PMCF survey is suitable for your device, contact us for a <strong>preliminary evaluation<\/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<section class=\"elementor-section elementor-top-section elementor-element elementor-element-b563df5 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"b563df5\" 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-8efb600\" data-id=\"8efb600\" 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-0105feb elementor-align-center elementor-widget elementor-widget-button\" data-id=\"0105feb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"mailto:info@clariscience.com\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">CONTACT US NOW<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\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},"excerpt":{"rendered":"<p>PMCF surveys are effective tools for collecting post-market clinical evidence quickly, sustainably, and in compliance with the MDR, when well designed. Discover Clariscience\u2019s dedicated PMCF survey service. <\/p>\n","protected":false},"author":94,"featured_media":53457,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"episode_type":"","audio_file":"","podmotor_file_id":"","podmotor_episode_id":"","cover_image":"","cover_image_id":"","duration":"","filesize":"","filesize_raw":"","date_recorded":"","explicit":"","block":"","powered_cache_disable_cache":false,"powered_cache_disable_css_optimization":false,"powered_cache_disable_js_optimization":false,"footnotes":""},"categories":[532],"tags":[575],"class_list":["post-55228","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulatory-affairs","tag-magazine-en"],"acf":[],"yoast_head":"<title>Survey PMCF: how to collect post-market clinical evidence effectively and in compliance - Clariscience<\/title>\n<meta name=\"description\" content=\"Learn how to design high-quality PMCF surveys to collect post-market clinical evidence in compliance with MDR. 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