{"id":8744,"date":"2025-08-05T21:52:31","date_gmt":"2025-08-05T21:52:31","guid":{"rendered":"https:\/\/www.orielstat.com\/blog\/?p=8744"},"modified":"2025-08-05T21:54:49","modified_gmt":"2025-08-05T21:54:49","slug":"psur-pmsr-requirements-in-eu-mdr-2","status":"publish","type":"post","link":"https:\/\/www.orielstat.com\/blog\/psur-pmsr-requirements-in-eu-mdr-2\/","title":{"rendered":"PSUR PMSR Requirements in EU MDR"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"8744\" class=\"elementor elementor-8744\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7388bb3 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7388bb3\" data-element_type=\"section\">\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-4264d41\" data-id=\"4264d41\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-d04a716 blog-details-page elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"d04a716\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&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-66 elementor-top-column elementor-element elementor-element-e193c4d\" data-id=\"e193c4d\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-aa22ff3 elementor-widget elementor-widget-post-info\" data-id=\"aa22ff3\" data-element_type=\"widget\" data-widget_type=\"post-info.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/elementor\/css\/custom-widget-icon-list.min.css?ver=0\"><link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/plugins\/elementor-pro\/assets\/css\/widget-theme-elements.min.css\">\t\t<ul class=\"elementor-inline-items elementor-icon-list-items elementor-post-info\">\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item-7f6be35 elementor-inline-item\" itemprop=\"datePublished\">\n\t\t\t\t\t\t<a href=\"https:\/\/www.orielstat.com\/blog\/2025\/08\/05\/\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-date\">\n\t\t\t\t\t\t\t\t\t\tAugust 5, 2025\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t<\/li>\n\t\t\t\t<\/ul>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-25cfb2d elementor-widget elementor-widget-heading\" data-id=\"25cfb2d\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h1 class=\"elementor-heading-title elementor-size-default\">PSUR PMSR Requirements in EU MDR<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-78a7c7e elementor-widget elementor-widget-image\" data-id=\"78a7c7e\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"2560\" height=\"1709\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2024\/01\/medical-research-scaled.jpeg\" class=\"attachment-full size-full wp-image-8282\" alt=\"\" loading=\"lazy\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2024\/01\/medical-research-scaled.jpeg 2560w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2024\/01\/medical-research-300x200.jpeg 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2024\/01\/medical-research-1024x683.jpeg 1024w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2024\/01\/medical-research-768x513.jpeg 768w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2024\/01\/medical-research-1536x1025.jpeg 1536w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2024\/01\/medical-research-2048x1367.jpeg 2048w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2024\/01\/medical-research-500x334.jpeg 500w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/>\t\t\t\t\t\t\t\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-f7a5edb elementor-widget elementor-widget-text-editor\" data-id=\"f7a5edb\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p><strong>In this article we will address these common questions:<\/strong><\/p><ul><li>What\u2019s the difference between a PSUR and a PMSR?<\/li><li>Which one is required for our devices?<\/li><li>How are they submitted and to whom?<\/li><li>How often do they need to be updated?<\/li><li>How do they relate to the\u00a0<a href=\"http:\/\/sd122:8080\/orielblog\/iso-tr-20416-pms-medical-devices\/\" target=\"_blank\" rel=\"noopener noreferrer\">PMS plan<\/a>?<\/li><\/ul><h3><br \/>What\u2019s the Difference Between a PSUR and a PMSR?<\/h3><p><strong>The PMSR is intended for low-risk Class I devices.<\/strong>\u00a0It needs to summarize the results and conclusions of your postmarket surveillance (PMS) data that you defined in your PMS plan (see\u00a0<a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/HTML\/?uri=CELEX:32017R0745&amp;from=EN#d1e6703-1-1\" target=\"_blank\" rel=\"noopener noreferrer\">MDR Article 84<\/a>\u00a0and\u00a0<a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/HTML\/?uri=CELEX:32017R0745&amp;from=EN#d1e32-112-1\" target=\"_blank\" rel=\"noopener noreferrer\">Annex III<\/a>\u00a0for more details about this document) along with a rationale for and description of any preventive and corrective actions taken for products on the market. This report becomes part of your technical documentation and is updated as needed and made available to EU Competent Authorities upon request.<\/p><p><strong>The PSUR is required for Class IIa, IIb, and III devices.<\/strong>\u00a0The PSUR is essentially an extension of a PMSR containing additional information for higher-risk devices. Like the PMSR, it summarizes the results and conclusions from your PMS data that you defined in the PMS plan and includes a rationale and description of any corrective actions taken for product on the market. The other specific required contents of this report are outlined in Article 86 of the MDR. The PSUR must also include:<\/p><ul><li><ul><li><ul><li>Conclusions of benefit-risk determination<\/li><li>Main findings of your postmarket clinical follow-up (PMCF)<\/li><li>Volume of devices placed on the market (this can be volume of sales, units shipped, episodes of use for reusable devices, etc.)<\/li><li>Estimates of size or other characteristics of people using the device (plus usage frequency if known)<\/li><\/ul><\/li><\/ul><\/li><\/ul><table><tbody><tr><td><em><strong>You\u2019ll find extensive information about the PSUR requirements in\u00a0<\/strong><a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/mdcg-2022-21-guidance-periodic-safety-update-report-psur-according-regulation-eu-2017745-december-2022-12-16_en\" target=\"_blank\" rel=\"noopener noreferrer\"><strong>MDCG 2022-21<\/strong><\/a><strong>,<\/strong><strong>\u00a0so be sure to download this.<\/strong><\/em><\/td><\/tr><\/tbody><\/table><h3>Does Our Device Require a PSUR or PMSR?<\/h3><p>The table below summarizes which report is required and when. The requirement to prepare a PSUR or PMSR applies to\u00a0<a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/mdcg-2021-25-application-mdr-requirements-legacy-devices-and-devices-placed-market-prior-26-may-2021-2021-10-21_en\" target=\"_blank\" rel=\"noopener noreferrer\">legacy device models<\/a>\u00a0as well.<\/p><table><tbody><tr bgcolor=\"#adc8e4\"><td><strong>Medical Device Classification<\/strong><\/td><td><strong>PMSR or PSUR?<\/strong><\/td><td><strong>Data Collection Begins<\/strong><\/td><td><strong>How Submitted?<\/strong><\/td><td><strong>Update Frequency<\/strong><\/td><td><strong>Conduct Reporting for How Long?<\/strong><\/td><td><strong>Upload* to EUDAMED?<\/strong><\/td><\/tr><tr><td>Class I \u2013 non-measuring, non-sterile, non-reusable<\/td><td>PMSR \u2013 see Article 85<\/td><td>May 26, 2021<\/td><td>To Competent Authority upon request<\/td><td rowspan=\"3\">As needed<\/td><td rowspan=\"3\">Not defined but assumed to be lifetime of device as defined in technical documentation<\/td><td rowspan=\"3\">No<\/td><\/tr><tr><td>Class I \u2013 reusable*<\/td><td>PMSR \u2013 see Article 85<\/td><td>Legacy MDD certs: May 26, 2021<p>\u00a0<\/p><p>MDR certs: Date of certification or DOC<\/p><\/td><td rowspan=\"2\">During Notified Body conformity assessment or upon request to Competent Authority<\/td><\/tr><tr><td>Class I \u2013 measuring, sterile<\/td><td>PMSR \u2013 see Article 85<\/td><td>Legacy MDD certs: May 26, 2021<p>\u00a0<\/p><p>\u00a0<\/p><p>MDR certs: Date of certification or DOC<\/p><\/td><\/tr><tr><td>Class IIa<p>\u00a0<\/p><p>Class IIb<\/p><p>Class III<\/p><\/td><td>PSUR \u2013 see Article 86<\/td><td>Legacy MDD certs: May 26, 2021<p>\u00a0<\/p><p>\u00a0<\/p><p>MDR certs: Date of certification<\/p><\/td><td>During Notified Body conformity assessment or upon request to Competent Authority<\/td><td>Class IIa: Every 2 years<p>\u00a0<\/p><p>\u00a0<\/p><p>Class IIb and III: Every year<\/p><\/td><td>Lifetime of\u00a0<strong>last<\/strong>\u00a0device placed on EU market \u2013 see section 3.2.2 of MDCG 2022-21<\/td><td>All MDR implantable and Class III devices: Yes*<p>\u00a0<\/p><p>All other MDD or MDR devices: No*<\/p><p>\u00a0<\/p><\/td><\/tr><\/tbody><\/table><h6><em>*See MDCG 2022-21 section 5.4 and table on page 36 of guidance<\/em><\/h6><h3>Elements of a PSUR Summary<\/h3><p>According to section 2.2.2 of\u00a0<a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/mdcg-2022-21-guidance-periodic-safety-update-report-psur-according-regulation-eu-2017745-december-2022-12-16_en\" target=\"_blank\" rel=\"noopener noreferrer nofollow noindex\">MDCG 2022-21<\/a>, your PSUR must summarize the results and findings after you have analyzed all relevant PMS data. You\u2019ll want to review Annexes I and III of the guidance for details of what is expected. This section also includes a listing of data that should be considered in your PMS data:<\/p><ul><li><ul><li>Information about serious incidents and Field Safety Corrective Actions (FSCA)<\/li><li>Analysis of nonserious incidents and undesirable side effects<\/li><li>Trend reporting<\/li><li>Feedback and complaint data from users, distributors, and importers<\/li><li>Publicly available data about devices similar to yours<\/li><\/ul><\/li><\/ul><p>Annex I of MDCG 2022-21 provides a detailed PSUR template you can follow, while Annexes II and III contain advice and templates on how to present data within your PSUR.<\/p><p>\u00a0<\/p><table><tbody><tr><td><h3><em><strong>What is an \u201cold\u201d medical device versus a \u201clegacy\u201d medical device?<\/strong><\/em><\/h3><p><em>An \u201cold\u201d device is defined as a medical device that was placed on the European market\u00a0<strong>before<\/strong>\u00a0May 26, 2021 \u2013 the EU MDR date of application \u2013 but is no longer being placed in the European market. PSUR\/PMSR requirements\u00a0<strong>do not apply<\/strong>\u00a0to old medical devices. \u201cLegacy\u201d medical devices hold valid MDD certificates and were placed on the European market\u00a0<strong>after<\/strong>\u00a0May 26, 2021. PSUR\/PMSR requirements\u00a0<strong>do apply<\/strong>\u00a0to legacy devices under the Article 120 Transitional Provisions.<\/em><\/p><\/td><\/tr><\/tbody><\/table><h3>Complying With the MDR<\/h3><p>The new PSUR requirements are an example of many new demands being placed on manufacturers by the European Union Medical Device Regulation. It can be difficult to make sense of it all, but there are two ways we can help. If you simply need to get a grip on all requirements in the MDR, consider our\u00a0<a href=\"https:\/\/www.orielstat.com\/courses\/eu-mdr-training\" target=\"_blank\" rel=\"noopener noreferrer\">MDR training class<\/a>. Ready to implement your PMS program? 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href=\"https:\/\/www.orielstat.com\/blog\/category\/software-cybersecurity\/\">Software and Cybersecurity<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-32\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/supplier-management\/\">Supplier Management<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-67\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/training\/\">Training<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-1\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/medical-device-ra-qa\/\">Uncategorized<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-35\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/validation\/\">Validation<\/a>\n<\/li>\n\t\t\t<\/ul>\n\n\t\t\t<\/section>\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\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>PSUR PMSR Requirements in EU MDR In this article we will address these common questions: What\u2019s the difference between a PSUR and a PMSR? Which one is required for our devices? How are they submitted and to whom? How often do they need to be updated? How do they relate to the\u00a0PMS plan? What\u2019s the [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":8282,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":[],"categories":[16],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.7 (Yoast SEO v21.7) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\r\n<title>Oriel STAT A MATRIX &#8211; ELIQUENT Life Sciences Blog<\/title>\r\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\r\n<link rel=\"canonical\" href=\"https:\/\/www.orielstat.com\/blog\/psur-pmsr-requirements-in-eu-mdr-2\/\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:description\" content=\"PSUR PMSR Requirements in EU MDR In this article we will address these common questions: What\u2019s the difference between a PSUR and a PMSR? Which one is required for our devices? How are they submitted and to whom? How often do they need to be updated? How do they relate to the\u00a0PMS plan? 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