{"id":6861,"date":"2026-06-10T17:37:45","date_gmt":"2026-06-10T12:07:45","guid":{"rendered":"https:\/\/operonstrategist.com\/?p=6861"},"modified":"2026-06-10T17:37:45","modified_gmt":"2026-06-10T12:07:45","slug":"post-market-surveillance-for-medical-devices","status":"publish","type":"post","link":"https:\/\/operonstrategist.com\/eg-en\/post-market-surveillance-for-medical-devices\/","title":{"rendered":"Why Post-Market Surveillance Is Important For Medical Devices?"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"6861\" class=\"elementor elementor-6861\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-47c46cf3 e-flex e-con-boxed e-con e-parent\" data-id=\"47c46cf3\" 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-3310df43 elementor-widget elementor-widget-heading\" data-id=\"3310df43\" 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\">Why Post-Market Surveillance Is Important For Medical Devices?<\/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-33d51041 e-flex e-con-boxed e-con e-parent\" data-id=\"33d51041\" 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-2e694fb3 e-con-full e-flex e-con e-child\" data-id=\"2e694fb3\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-dd8969b elementor-widget elementor-widget-text-editor\" data-id=\"dd8969b\" 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>\u00a0<\/p><p><span style=\"font-weight: 400;\">Around the world, medical devices play a vital role in the diagnosis, treatment, cure, prevention, or mitigation of disease, disorder, or conditions. Medical devices can be instruments, apparatus, machines, implants, or other similar objects that professionals can use. Around the world, regulatory bodies or authorities regulate medical devices in terms of quality, safety, and efficacy. The work of regulatory authorities is not till the devices are marketed but continues even after that, known as post-market surveillance. The post-market surveillance is more or less the responsibility of the manufacturer. Regulatory bodies worldwide are working continuously to detect the defects of medical devices (if any) as early as possible. But still, there are some defects which come to attention once they are marketed and sold, used by the professionals and intended for use. That\u2019s why regulatory bodies came up with post-market surveillance so that even when the intended population uses the medical device, the manufacturer can rectify the defects to increase safety and give the user a pleasant experience.\u00a0<\/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-3297fe6b e-con-full e-flex e-con e-child\" data-id=\"3297fe6b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-765520c7 e-con-full e-flex e-con e-child\" data-id=\"765520c7\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-12037efb elementor-widget elementor-widget-heading\" data-id=\"12037efb\" 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\">Talk to our medical device experts!\n<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-53edda66 elementor-widget elementor-widget-wpforms\" data-id=\"53edda66\" 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\/6861\" data-token=\"24a33a86f378ed1e881eb77b5877b2eb\" data-token-time=\"1781101403\"><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 Phone Name<\/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\/6861\"><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-5464aca4 e-flex e-con-boxed e-con e-parent\" data-id=\"5464aca4\" 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-7ef35174 elementor-widget elementor-widget-heading\" data-id=\"7ef35174\" 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 post-market surveillance (PMS)? \n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2e1c5368 elementor-widget elementor-widget-text-editor\" data-id=\"2e1c5368\" 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;\">PMS is the procedure that requires the manufacturers to monitor devices even after they are marketed and are within reach of common and professional people. PMS is a type of ongoing assessment of safety and effectiveness. The main aim of PMS is to keep an eye on the medical device after they are being used so that even if there is any complaint about the device, authorities can rectify that before it harms a large scale. The post-market surveillance depends on the data collected by the manufacturer, reports of incidents given by the people using the device etc.\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">To conduct post market surveillance manufacturers should develop a PMS plan which is part of technical documentation in EU manufacturers need to submit <\/span><span style=\"font-weight: 400;\">PSUR<\/span><span style=\"font-weight: 400;\">.\u00a0\u00a0<\/span><\/p><h5><span style=\"font-weight: 400;\">The main aims of post-market surveillance are:\u00a0<\/span><\/h5><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Analytically identifying the risks stirring during the usage practically.\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Monitoring the device\u2019s performance when on the field.\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Identifying the device\u2019s faults and safety issues which were not detected earlier.\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Updating the benefit-risk assessment continuously\u00a0<\/span><\/li><\/ul><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Taking necessary measures on the recalls.\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Detect the adverse event of the product marketing\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Compare the new product with already available products in the market\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Update the clinical guidelines\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Comply with regulations\u00a0\u00a0<\/span><\/li><\/ul><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><i><span style=\"font-weight: 400;\">The information obtained from post-market surveillance is used to update the following:<\/span><\/i><span style=\"font-weight: 400;\">\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Benefit-risk determination\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Information on design and manufacturing\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Instructions of use, labelling\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Clinical evaluation report\u00a0<\/span><\/li><\/ul><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Summary of safety and clinical performance (if applicable)\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Technical documentation\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Detect the repeating trends\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Identify the corrective and protective actions\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Post-market surveillance of related devices (if applicable)\u00a0<\/span><\/li><\/ul><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Improvement in usability, performance and safety of the device\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Improve the management of risks associated\u00a0<\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fac551f elementor-widget elementor-widget-heading\" data-id=\"fac551f\" 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\">Types of Post-Market Surveillance: Proactive VS Reactive: \n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b335827 elementor-widget elementor-widget-text-editor\" data-id=\"b335827\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<table><tbody><tr><td><p><span style=\"font-weight: 400;\">Proactive\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Reactive\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">Involves survey of customer\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Complaints of customers\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">Includes PMCF\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">User feedback (complaints excluded)\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">Device tracking\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Service report\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">Product quality review\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">In-house testing\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">Risk assessment periodically\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Analysis of failure\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">Focus group\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Social media\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Literature review\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Regional or national device registry\u00a0<\/span><\/p><\/td><\/tr><\/tbody><\/table>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b69add9 elementor-widget elementor-widget-heading\" data-id=\"b69add9\" 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\">Steps to conduct the post-market surveillance: \n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f4959fa elementor-widget elementor-widget-text-editor\" data-id=\"f4959fa\" 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;\">Step 1 \u2013 PMS plan development:\u00a0\u00a0<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">It includes an assessment of whether post-market surveillance is required, and if yes, then list out the requirements:\u00a0<\/span><\/li><\/ul><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Information on both serious and non-serious events\u00a0<\/span><\/li><\/ul><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Undesirable side-effects\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Technical information\u00a0\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Feedback and complaints\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Information on similar medical devices\u00a0<br \/><br \/><\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">Step 2 \u2013 Plan implementation:\u00a0<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Implementation is required after the plan is generated. It includes data collection, routings, approvals, follow-ups, reminders etc.\u00a0<br \/><br \/><\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">Step 3 \u2013 Report generation based on PMS findings:\u00a0\u00a0<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">A variety of documents are generated during the PMS process. The PMS report shall contain a summary of all the outcomes and decisions used when the data on PMS was collected.\u00a0<br \/><br \/><\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">Step 4 \u2013 Perform the tasks related to vigilance:\u00a0\u00a0<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Vigilance helps in uncovering the adverse events which went unnoticed, enabling to prevent of such incidents in future.<br \/><br \/><\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">Step 5 \u2013 Forms management module:\u00a0\u00a0<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">It includes forms such as <a href=\"https:\/\/operonstrategist.com\/risk-based-capa-process\/\">CAPAs<\/a>, complaints, NCs etc. A proper channel is required to manage the process for distribution, processing, completing and collecting forms. <\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ba06c41 elementor-widget elementor-widget-heading\" data-id=\"ba06c41\" 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\">Post-market surveillance in the US and Europe: \n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-920c2f5 elementor-widget elementor-widget-text-editor\" data-id=\"920c2f5\" 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;\">IN USA\u00a0<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">There are different sections in the <a href=\"https:\/\/operonstrategist.com\/elevateplus\/us-fda-510k-qsmr-registration\/\">USFDA<\/a> under the code of federal regulations (CFR) that regulates post-market surveillance in the US.\u00a0<\/span><\/li><\/ul><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">21 CFR 822 \u2013 Consist of details on the post-market surveillance requirements in the USA.\u00a0\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">When post-market surveillance is necessary\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Documents to produce\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The period under which a manufacturer must react to an adverse event report.\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Healthcare professionals and consumers in the USA can use MedWatch to submit their complaints about adverse events.\u00a0<\/span><\/li><\/ul><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">There is a database called MAUDE, which the FDA uses to house the reports of medical devices submitted to the FDA by manufacturers, importers and device user facilities or institutions and other reporters such as healthcare professionals, patients and consumers.\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">The class of medical device decides the post-market surveillance necessity; the high-risk class medical devices require post-market surveillance, whereas class I medical devices can be exempted.<\/span><\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">IN EUROPE\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">The European Union Annex III of Medical device regulation 2017\/745 deals with post-market surveillance.\u00a0<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Article 15 \u2013 People responsible for PMS\u00a0<\/span><\/li><\/ul><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Article 83 \u2013 Post-market surveillance plan for manufacturer\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Article 84 \u2013 Post-market surveillance plan\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Article 85 \u2013 Post-market surveillance report\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Article 86 \u2013 Periodic safety update report.\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Annex III \u2013 Technical documentation for post-market surveillance system\u00a0<\/span><\/li><\/ul><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The manufacturers need to perform the post-market clinical follow-up, and there must be a justification in case of the absence of PMCF.\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">PMCF is part of the PMS, and PMCF depends on the device\u2019s risk and novelty.\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Unlike in the USA in Europe, it is mandatory to have post-market surveillance reports for medical devices of all the classes.<\/span><\/span><p>\u00a0<\/p><\/li><\/ul><p><a href=\"https:\/\/operonstrategist.com\/10-essential-strategies-for-effective-post-market-surveillance-under-eu-mdr\/\">10 Essential Strategies for Effective Post-Market Surveillance under EU-MDR<\/a><\/p><p><span style=\"font-weight: 400;\">Other than regulations of a country, standards such as ISO\/TR 20416:2020 also cover medical devices \u2013 post-market surveillance for manufacturers. It is mainly used by the manufacturers of medical devices, as this standard is consistent and relevant to standards such as <\/span><i><span style=\"font-weight: 400;\">ISO 13485<\/span><\/i><span style=\"font-weight: 400;\"> and <\/span><i><span style=\"font-weight: 400;\">ISO 14971.<\/span><\/i><span style=\"font-weight: 400;\"> This standard helps the manufacturers to understand how to collect and analyze the data, information on the feedback process etc.\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">The main aim of post-market surveillance is to ensure that the device, even when marketed, is safe for the intended population. It is an important process through which one can increase the benefit-risk ratio. With the post-market, one can improve the quality of the medical devices and make the user experience smoother. While conducting the Post market surveillance manufacturers take assistance from medical device regulatory consultants. As a Medical device regulatory consultant we provide assistance to manufacturers in creating a file of technical documents or <a href=\"https:\/\/operonstrategist.com\/mastering-psur-compliance-for-medical-devices\/\">PSUR<\/a>. So that they can easily conduct Post market surveillance for their devices. <\/span><\/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>Around the world, medical devices play a vital role in the diagnosis, treatment, cure, prevention, or mitigation of disease, disorder, or conditions. Medical devices can be instruments, apparatus, machines, implants, or other similar objects that professionals can use. Around the world, regulatory bodies or authorities regulate medical devices in terms of quality, safety, and efficacy. [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":12776,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[55],"tags":[],"class_list":["post-6861","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\/6861","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=6861"}],"version-history":[{"count":1,"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/posts\/6861\/revisions"}],"predecessor-version":[{"id":12777,"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/posts\/6861\/revisions\/12777"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/media\/12776"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/media?parent=6861"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/categories?post=6861"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/operonstrategist.com\/eg-en\/wp-json\/wp\/v2\/tags?post=6861"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}