{"id":8989,"date":"2023-10-24T17:35:45","date_gmt":"2023-10-24T22:35:45","guid":{"rendered":"https:\/\/casusconsulting.com\/?p=8989"},"modified":"2024-05-05T17:38:08","modified_gmt":"2024-05-05T22:38:08","slug":"eu-shelf-expiration-expected-lifetime-useful-service-life","status":"publish","type":"post","link":"https:\/\/casusconsulting.com\/eu-shelf-expiration-expected-lifetime-useful-service-life\/","title":{"rendered":"EU Guide: Shelf Life, Expiration Date, Expected Lifetime\/Useful Life, Service Life, Life Cycle"},"content":{"rendered":"\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-10 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:5%\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:85%\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<!-- Smartsupp Live Chat script -->\r\n\r\n<script type=\"text\/javascript\">\r\n\r\nvar _smartsupp = _smartsupp || {};\r\n\r\n_smartsupp.key = 'aa3132da0431967288b8cf85dfdfa7626d7ecfd3';\r\n\r\nwindow.smartsupp||(function(d) {\r\n\r\n         var s,c,o=smartsupp=function(){ o._.push(arguments)};o._=[];\r\n\r\n         s=d.getElementsByTagName('script')[0];c=d.createElement('script');\r\n\r\n         c.type='text\/javascript';c.charset='utf-8';c.async=true;\r\n\r\n         c.src='https:\/\/www.smartsuppchat.com\/loader.js?';s.parentNode.insertBefore(c,s);\r\n\r\n})(document);\r\n\r\n<\/script>\n\n\n\n<p><script src=\"https:\/\/9931674141ca41baa2023404fd2333a2.js.ubembed.com\" async=\"\"><\/script><\/p>\n\n\n\n<p><em>Page Last Updated: 18 December 2023<\/em><\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-1 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:90%\"><div class=\"wp-block-ub-table-of-contents-block ub_table-of-contents\" data-showtext=\"show\" data-hidetext=\"hide\" data-scrolltype=\"auto\" id=\"ub_table-of-contents-27fd7742-1a35-4448-b212-230a4ba7077b\" data-initiallyhideonmobile=\"false\"\n                    data-initiallyshow=\"true\"><div class=\"ub_table-of-contents-header-container\"><div class=\"ub_table-of-contents-header\">\n                    <div class=\"ub_table-of-contents-title\">Table of Contents<\/div><\/div><\/div><div class=\"ub_table-of-contents-extra-container\"><div class=\"ub_table-of-contents-container ub_table-of-contents-1-column \"><ul><li><a href=https:\/\/casusconsulting.com\/eu-shelf-expiration-expected-lifetime-useful-service-life\/#0-shelf-life->Shelf Life<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/eu-shelf-expiration-expected-lifetime-useful-service-life\/#1-expiration-date->Expiration Date<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/eu-shelf-expiration-expected-lifetime-useful-service-life\/#2-expected-lifetime-useful-life->Expected Lifetime \/ Useful Life<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/eu-shelf-expiration-expected-lifetime-useful-service-life\/#3-examples-shelf-life-expiration-date-lifetime->Examples: Shelf Life, Expiration Date, Lifetime<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/eu-shelf-expiration-expected-lifetime-useful-service-life\/#4-end-of-life->End of Life<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/eu-shelf-expiration-expected-lifetime-useful-service-life\/#5-service-life->Service Life<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/eu-shelf-expiration-expected-lifetime-useful-service-life\/#6-life-cycle->Life Cycle<\/a><\/li><\/ul><\/div><\/div><\/div>\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>The EU MDR\/IVDR does not explicitly define shelf life, expiration date, expected lifetime\/useful life, service life, or life cycle for medical devices. Below we provide some clarification between these terms.<\/p>\n<\/div>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading has-black-color has-text-color has-large-font-size\" id=\"0-shelf-life-\"><strong>Shelf Life<\/strong><\/h2>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-2 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:90%\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<p class=\"has-black-color has-text-color\">Shelf-life is how long the device (in its original packaging) is known to be safe for use, between its manufacture date and its first use. Typically, it is applicable to devices with some characteristic that may degrade while awaiting first use. This could be something within the device itself (e.g., liquid) or the packaging (e.g., sterile pouch).<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">Shelf life is generally determined by the manufacturer through testing, e.g., accelerated\/real-time testing which replicate the expected conditions for transport, storage and handling. Factors for determining shelf-life include the materials used to manufacture the device (including if they expire), packaging materials, and shipping\/storage conditions. <\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">If a manufacturer states that the shelf-life of the device is two years, it is expected they can empirically validate that the device does not degrade within that timeframe.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">Shelf life can and may be extended by the manufacturer, as long as evidence is generated to support the longer shelf-life.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">Examples of why a device may be considered unusable include deterioration of sterility of the product packaging or a decrease in the effectiveness of substance-based devices, such as the drying out of the gel on defibrillator pads.<\/p>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-black-color has-text-color has-large-font-size\" id=\"1-expiration-date-\"><strong>Expiration Date<\/strong><\/h2>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-3 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:90%\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<p class=\"has-black-color has-text-color\">The expiration date is the date the product loses stability and no longer functions as intended. And therefore, can no longer be safely used.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">Generally, expiration dates are given to products that have some characteristic that will degrade within a certain timeframe, e.g., the acidity level in contact lens solutions.<\/p>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-4 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:90%\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<h2 class=\"wp-block-heading has-black-color has-text-color has-large-font-size\" id=\"2-expected-lifetime-useful-life-\"><strong>Expected Lifetime \/ Useful Life<\/strong><\/h2>\n\n\n\n<p class=\"has-black-color has-text-color\">The terms expected lifetime and useful life are generally synonymous. &nbsp;<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">The expected lifetime is how long the device is anticipated to safely meet its intended purpose. It is generally the time between the first use of the device and the timeframe when it is 1) used to its intended purpose (e.g., single-use consumable), 2) the device expires (e.g., a liquid based product), or 3) the failure intensity becomes unacceptable or when the device has an unrepairable failure (e.g., electromedical equipment). &nbsp;<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">The expected lifetime is determined by the manufacturer, taking into consideration risk assessment, product testing, usability testing, post-market data, shelf-life (if applicable), expiration dates (if applicable), and other similar factors.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">A device\u2019s lifetime may range from 10+ years (with proper maintenance and servicing) for some hospital equipment, to less than 60 minutes for consumables. For reusable devices, it may include a maximum number of uses, with criteria established regarding when the device may no longer be safely reused.<\/p>\n\n\n\n<p><strong>Further Reading<\/strong><\/p>\n\n\n\n<p>Team Notified Body released a position paper on Medical Device Lifetime. It provides a common understanding of the term under the MDR, ways to determine lifetime, and recommendations to manufacturers: <strong><a href=\"https:\/\/casusconsulting.com\/team-notified-body-nb-position-paper-medical-device-lifetime\/\" data-type=\"link\" data-id=\"https:\/\/casusconsulting.com\/team-notified-body-nb-position-paper-medical-device-lifetime\/\" target=\"_blank\" rel=\"noreferrer noopener\">Team NB Position Paper &#8211; Medical Device Lifetime<\/a><\/strong><\/p>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-6 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:90%\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<h2 class=\"wp-block-heading has-black-color has-text-color has-large-font-size\" id=\"3-examples-shelf-life-expiration-date-lifetime-\"><strong>Examples: Shelf Life, Expiration Date, Lifetime<\/strong><\/h2>\n\n\n\n<p class=\"has-black-color has-text-color\">A medical device\u2019s shelf life, expiration date, and expected lifetime can be different. &nbsp;<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">For example:<\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-5 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:1%\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:99%\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<ul class=\"has-black-color has-text-color\">\n<li>A device containing active ingredients may have a shelf-life of four years, and that is also the expected lifetime for that device.<\/li>\n\n\n\n<li>A device has a shelf-life of four years, but it expires within one year of opening, even if it is opened well before the four-year shelf-life.<\/li>\n\n\n\n<li>A device has a shelf-life of three years due to its sterile packaging, but once opened, it is implanted and has a much longer expected lifetime.<\/li>\n\n\n\n<li>A device does not have specific qualities that warrant a specific shelf-life, per se. However, the device is determined to have a 7-year expected lifetime\/useful life by the manufacturer.<\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n<\/div>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-black-color has-text-color has-large-font-size\" id=\"4-end-of-life-\"><strong>End of Life<\/strong><\/h2>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-8 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:90%\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<p class=\"has-black-color has-text-color\">End of life is generally interpreted to mean when the device will no longer be manufactured and supported. <\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">This may consist of the following phases: <\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:1%\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:99%\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<ul class=\"has-black-color has-text-color\">\n<li>Device is no longer manufactured<\/li>\n\n\n\n<li>Manufacturer stops actively promoting the device (&#8220;end of marketing life&#8221;), though it may still be available for sale and\/or servicing support<\/li>\n\n\n\n<li>End of maintenance and support for devices on the market<\/li>\n\n\n\n<li>It may also include decommissioning the product, i.e., removal or disconnection of the device from the healthcare facility for alternative use (e.g., refurbishing, donation, trade-in) or disposal<\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<p>Manufacturers should create a procedure to document a product&#8217;s end of life, including steps, timing, and internal\/external communication. For example, electronic devices should be disposed of in accordance with the WEEE Directive; regulatory databases should be updated (EUDAMED\/GUDID\/PARD) to add the commercial end date; etc. <\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-black-color has-text-color has-large-font-size\" id=\"5-service-life-\"><strong>Service Life<\/strong><\/h2>\n\n\n\n<p class=\"has-black-color has-text-color\">The service\/support life is generally the length of time that the manufacturer will service devices still in the field, including cybersecurity, if applicable.  <\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">This timeframe is determined by the manufacturer. In addition to factors such as expected lifetime and environmental conditions, they may also consider the cost and availability of spare parts.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">IEC 60601-1 states the expected service life is the:<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-background\" style=\"background-color:#f8f8f8\"><em>\u201c\u2026time period specified by the manufacturer during which the ME equipment or ME system is expected to remain safe for use (e.g., maintain basic safety and essential performance); <\/em><\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-background\" style=\"background-color:#f8f8f8\"><em>(Note: Maintenance may be necessary during the Expected Service Life.)\u201d<\/em><\/p>\n\n\n\n<p>Further, IEC 60601-1 states that the Instructions for Use (IFU) should include:<\/p>\n\n\n\n<ul style=\"background-color:#f8f8f8\" class=\"has-black-color has-text-color has-background\">\n<li><em>\u201cthe EXPECTED SERVICE LIFE of the ME EQUIPMENT;<\/em><\/li>\n\n\n\n<li><em>the EXPECTED SERVICE LIFE of parts or ACCESSORIES shipped with the ME EQUIPMENT; and<\/em><\/li>\n\n\n\n<li><em>where the SHELF LIFE is less than the EXPECTED SERVICE LIFE, the SHELF LIFE of parts or ACCESSORIES shipped with the ME EQUIPMENT.\u201d<\/em><\/li>\n<\/ul>\n\n\n\n<p class=\"has-black-color has-text-color\">For products that require servicing, the manufacturer should have a plan for notifying users that the device is being retired and when the device will no longer be eligible for support. <\/p>\n\n\n\n<p class=\"has-black-color has-text-color\">Of course, manufacturers may still receive inquiries after a device&#8217;s service life has passed. As best practice, manufacturers should document how to handle service inquiries for discontinued products, or products past their service life. This may be as simple as a script for customer service, explaining the situation and advising of alternative devices currently being manufactured and eligible for servicing.<\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:90%\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<h2 class=\"wp-block-heading has-black-color has-text-color has-large-font-size\" id=\"6-life-cycle-\"><strong>Life Cycle<\/strong><\/h2>\n\n\n\n<p>A medical device&#8217;s life cycle is generally all phases, including shelf life, expected lifetime, and service life.<\/p>\n\n\n\n<p>The device lifecycle is typically considered from the point of conception (research &amp; development) to the point there are no devices left on the market. For example, even if the device has been decommissioned (no longer being manufactured or serviced), the manufacturer should still document reactive data as part of its Post-market Surveillance, e.g., complaints and vigilance received for products still in the field. This data may then warrant updates to the Clinical Evaluation Report.<\/p>\n\n\n\n<p>NOTE: this page does not consider refurbished or re-manufactured devices beyond the manufacturer\u2019s intended lifetime. Doing such would generally create a &#8216;new&#8217; device, with a new expected lifetime.<\/p>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<\/div><\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Overview of Shelf Life, Expiration Dates, Device Lifetime\/Useful Life and Service Life for medical devices and IVDs in Europe.<\/p>\n","protected":false},"author":4,"featured_media":8993,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"ub_ctt_via":"","footnotes":""},"categories":[38,39,40],"tags":[],"cp_meta_data":{"_edit_lock":["1714948690:4"],"_tve_js_modules_gutenberg":["a:1:{i:0;s:9:\"gutenberg\";}"],"_edit_last":["4"],"hefo_before":["0"],"hefo_after":["0"],"cmplz_hide_cookiebanner":[""],"mfn-post-hide-content":["0"],"mfn-post-layout":["no-sidebar"],"mfn-post-sidebar":["0"],"mfn-post-sidebar2":["0"],"mfn-post-template":["intro"],"mfn-post-slider":["0"],"mfn-post-slider-layer":["0"],"mfn-post-full-width":["0"],"mfn-post-hide-title":["0"],"mfn-post-remove-padding":["0"],"mfn-post-intro":["a:1:{s:9:\"post-meta\";s:1:\"1\";}"],"mfn-post-hide-image":["0"],"jbp-single-post":["a:3:{s:8:\"override\";s:1:\"0\";s:22:\"single_template_custom\";s:1:\"0\";s:5:\"nonce\";s:10:\"243494e34d\";}"],"_wpb_vc_js_status":["false"],"_genesis_title":["2024 EU Guide: Shelf Life\/Lifetime\/Service Life\/Lifecycle"],"_genesis_description":["Overview of Shelf Life, Expiration Dates, Device Lifetime\/Useful Life and Service Life for medical devices and IVDs in Europe."],"mfn-meta-seo-title":["2024 EU Guide: Shelf Life\/Lifetime\/Service Life\/Lifecycle"],"mfn-meta-seo-description":["Overview of Shelf Life, Expiration Dates, Device Lifetime\/Useful Life and Service Life for medical devices and IVDs in Europe."],"_primary_term_category":["38"],"_thumbnail_id":["8993"],"footnotes":[""],"_cmplz_scanned_post":["1"]},"featured_image_src":"https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/10\/shutterstock_2018639645-scaled.jpg","author_info":{"display_name":"annmarie","author_link":"https:\/\/casusconsulting.com\/author\/annmarie\/"},"_links":{"self":[{"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/posts\/8989"}],"collection":[{"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/comments?post=8989"}],"version-history":[{"count":59,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/posts\/8989\/revisions"}],"predecessor-version":[{"id":12116,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/posts\/8989\/revisions\/12116"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/media\/8993"}],"wp:attachment":[{"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/media?parent=8989"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/categories?post=8989"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/tags?post=8989"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}