{"id":97737,"date":"2024-04-16T08:43:13","date_gmt":"2024-04-16T06:43:13","guid":{"rendered":"https:\/\/lightweb.dev\/s\/key2compliance\/?p=97737"},"modified":"2024-05-29T10:44:21","modified_gmt":"2024-05-29T08:44:21","slug":"fundamentals-of-the-technical-documentation","status":"publish","type":"post","link":"https:\/\/lightweb.dev\/s\/key2compliance\/blog\/fundamentals-of-the-technical-documentation\/","title":{"rendered":"Fundamentals of the technical documentation"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"97737\" class=\"elementor elementor-97737\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-78df4ccc elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"78df4ccc\" data-element_type=\"section\" data-e-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-50 elementor-inner-column elementor-element elementor-element-6ff8b091\" data-id=\"6ff8b091\" 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-3b6773bd elementor-widget__width-initial elementor-widget elementor-widget-image\" data-id=\"3b6773bd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/elementor\/thumbs\/Anna_Szczepkowska_600-rm31yznorrrygdjyxlcm88fz6i4t3gvxvvy9is2dig.avif\" title=\"Anna_Szczepkowska_600\" alt=\"Anna Szczepkowska\" loading=\"lazy\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-7bf1c9f1\" data-id=\"7bf1c9f1\" 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-1d9b2536 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"1d9b2536\" 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>Anna Szczepkowska<br \/>Consultant, Medical Device QA<\/p>\t\t\t\t\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-7cd53367 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7cd53367\" data-element_type=\"section\" data-e-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-52412d07\" data-id=\"52412d07\" 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-432c3314 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"432c3314\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<h3>Introduction<\/h3><p>Technical documentation, also known as technical file, is a set of the documents that contains all the technical information concerning a medical device. Therefore, every EU manufacturer of medical devices (regardless of risk class) must according to regulations create technical documentation. This must include clear information regarding design, manufacture, and operation of the device.\u00a0<br \/><span style=\"color: var( --e-global-color-text );\">The journey manufacturers need go through to meet regulatory requirements \u2013 and get the CE mark \u2013 is often very complex. An example of this process is presented in <\/span><em style=\"color: var( --e-global-color-text );\">Figure 1<\/em><span style=\"color: var( --e-global-color-text );\"> below.\u00a0<\/span><\/p><p>In this article, we will focus on the MDR requirements. The MDR (Medical Device Regulation 2017\/745) replaces MDD (Medical Device Directive 93\/42\/ECC). For MDD devices already on the market the transition to MDR is often described as \u201cdemanding\u201d and \u201cexpensive\u201d. However, it is good to keep in mind that by creating a well-planned regulatory strategy and preparing the technical documentation \u201cas good as possible from the beginning\u201d can facilitate a smooth process.<\/p>\t\t\t\t\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-fd5d626 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"fd5d626\" data-element_type=\"section\" data-e-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-2bc8a17\" data-id=\"2bc8a17\" 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-a8426e4 elementor-widget elementor-widget-image\" data-id=\"a8426e4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"800\" height=\"402\" src=\"https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2024\/03\/device_launching_1200-1024x514.avif\" class=\"attachment-large size-large wp-image-98224\" alt=\"Table showing the stages during medical device development and launch\" srcset=\"https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2024\/03\/device_launching_1200-1024x514.avif 1024w, https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2024\/03\/device_launching_1200-300x151.avif 300w, https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2024\/03\/device_launching_1200-768x385.avif 768w, https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2024\/03\/device_launching_1200-600x301.avif 600w, https:\/\/lightweb.dev\/s\/key2compliance\/wp-content\/uploads\/2024\/03\/device_launching_1200.avif 1200w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-09b4b88 elementor-widget elementor-widget-text-editor\" data-id=\"09b4b88\" 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><em>Figure 1. The process of the device launching<\/em><\/p>\t\t\t\t\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-dc81308 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"dc81308\" data-element_type=\"section\" data-e-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-a6493a9\" data-id=\"a6493a9\" 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-6bff262 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"6bff262\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<h3><span style=\"color: var( --e-global-color-primary );\">What are the obligations of the manufacturer?<\/span><\/h3><p>A manufacturer of the medical device is obligated to:<\/p><ul><li>prepare technical documentation before placing a device on the market;<\/li><li>supply technical documentation on devices greater than class I, for review and approval of a Notified Body before making the device available on the market;<\/li><li>maintain the technical documentation throughout the device\u2019s entire life cycle;<\/li><li>file technical documentation available for <span class=\"ui-provider a b c d e f g h i j k l m n o p q r s t u v w x y z ab ac ae af ag ah ai aj ak\" dir=\"ltr\">Competent Authorities<\/span> (CAs) for 10 years after previous device was placed on the market. Or 15 years for implantable devices.<\/li><\/ul><p>The technical documentation must show that the medical device conforms to applicable regulatory requirements such as MDR. Which therefore ensures that the medical device is safe and effective.<\/p><h3>Key components of technical documentation<\/h3><p>Key components of the technical documentation are specified in Annex II and Annex III in the MDR and \u201cshall be presented in a clear, organized, readily searchable and unambiguous manner\u201d (Annex II, point 1.1.1 (a)):<\/p><p><strong style=\"color: var( --e-global-color-text );\">Annex II \u2013\u00a0Technical Documentation<\/strong><\/p><ol><li>Device Description and Specification, including variants and accessories.<ol><li>Device Description and Specification<\/li><li>Reference to previous and similar generations of the device<\/li><\/ol><\/li><li>Information to be supplied by the manufacturer<\/li><li>Design and Manufacturing Information<\/li><li>General Safety and Performance Requirements<\/li><li>Benefit-Risk Analysis and Risk Management<\/li><li>Device Verification and Validation<ol><li>Pre-clinical and Clinical data<\/li><li>Additional information required in specific cases.<\/li><\/ol><\/li><\/ol><p><strong style=\"color: var( --e-global-color-text );\">\u00a0<\/strong><\/p><p><strong style=\"color: var( --e-global-color-text );\">Annex III \u2013 Technical Documentation on Post Market Surveillance<\/strong><\/p><ol><li>The Post Market Surveillance Plan<\/li><li>The PSUR (Periodic Safety Update Report)<\/li><li>PMS Report<\/li><\/ol><div><span style=\"color: var( --e-global-color-text );\">\u00a0<\/span><\/div><div><span style=\"color: var( --e-global-color-text );\">These are similar to the MDD but there are additional requirements concerning all sections. However, the most significant changes have been made in conjunction with the sub-section 6.1 \u201cPre-clinical and Clinical data\u201d and technical documentation on the Post Market Surveillance, according to Annex III. The technical documentation regarding this part shall consist of the PMS plan (according to art. 84); a Periodic Safety Update Report (PSUR) for devices greater than class I (art 86 of MDR); or a PMS Report for devices of class I (article 85 of the MDR).<\/span><br \/><span style=\"color: var( --e-global-color-primary ); font-size: 26px;\"><br \/><\/span><\/div><h3><span style=\"color: var( --e-global-color-primary ); font-size: 26px;\">How to create and maintain the technical documentation?<\/span><\/h3><p>As mentioned above, the technical documentation preferably presents as clear, organised, and unambiguous. Also, following applicable standards and guidelines increases the probability of good technical documentation which is easy to maintain. The Notified Body, which the manufacturer has a signed contract with, usually prepares a technical guidance with clear instruction on how the technical documentation should be submitted. To follow this guidance can increase the speed of the Notified Body review. The support of an experienced person, for instance a consultant, can enable this process. Since the technical documentation is often considerable, the choice of storage is important. Using an electronic signing and storage solution can save a lot of time. It can also improve the possibility of maintaining the technical documentation up to date during the device\u2019s entire life cycle.<\/p><h3>Common challenges and solutions<\/h3><p>A common challenge is estimating the time and resources needed for a Notified Body submission. Project planning, as well as having available resources to answer the Notified Bodies questions, play a crucial role to get approval and getting the device on the market. The support of an experienced person, for instance a consultant can enable a smooth process.<\/p><h3>Conclusion<\/h3><p>As presented, the preparation of technical documentation is a requirement that needs to be fulfilled to place a device on the European market. Once it is done, it is important to keep the technical documentation up to date according to the latest regulations. Compared with the MDD requirements, the expected quality of the technical documentation has increased in conjunction with the MDR transition. The inclusion of the PMS requirements, according to Annex III of the MDR and stricter requirements on clinical data, mean that manufacturers must improve the scientific quality of technical documentation. At Key2Complaince, we will help you every step of the way when creating a technical documentation, and also keeping it up to date.<\/p><p><a href=\"https:\/\/lightweb.dev\/s\/key2compliance\/about-us\/#contact\"><strong>For more information, please contact one of our experts &gt;<\/strong><\/a><\/p>\t\t\t\t\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>Anna SzczepkowskaConsultant, Medical Device QA Introduction Technical documentation, also known as technical file, is a set of the documents that contains all the technical information concerning a medical device. Therefore, every EU manufacturer of medical devices (regardless of risk class) must according to regulations create technical documentation. This must include clear information regarding design, manufacture, [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":99913,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"wds_primary_category":192,"footnotes":""},"categories":[192,21],"tags":[117,348],"blog-subject":[],"class_list":["post-97737","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","category-news","tag-medical-device","tag-technical-documentation"],"acf":[],"_links":{"self":[{"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/posts\/97737","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/comments?post=97737"}],"version-history":[{"count":0,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/posts\/97737\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/media\/99913"}],"wp:attachment":[{"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/media?parent=97737"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/categories?post=97737"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/tags?post=97737"},{"taxonomy":"blog-subject","embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/blog-subject?post=97737"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}