{"id":9944,"date":"2022-02-22T09:43:37","date_gmt":"2022-02-22T09:43:37","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=9944"},"modified":"2022-02-22T10:02:12","modified_gmt":"2022-02-22T10:02:12","slug":"medical-device-technical-file-checklist-the-ultimate-guide","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/medical-device-technical-file-checklist-the-ultimate-guide\/","title":{"rendered":"Medical Device Technical File Checklist: The Ultimate Guide"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_45_1 counter-flat ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" area-label=\"ez-toc-toggle-icon-1\"><label for=\"item-69f513f29d038\" aria-label=\"Table of Content\"><span style=\"display: flex;align-items: center;width: 35px;height: 30px;justify-content: center;direction:ltr;\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/label><input  type=\"checkbox\" id=\"item-69f513f29d038\"><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-technical-file-checklist-the-ultimate-guide\/#Download_the_Medical_Device_Technical_File_Checklist\" title=\"Download the Medical Device Technical File Checklist\">Download the Medical Device Technical File Checklist<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-technical-file-checklist-the-ultimate-guide\/#Device_description_specifications\" title=\"Device description &amp; specifications\u00a0\">Device description &amp; specifications\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-technical-file-checklist-the-ultimate-guide\/#Information_to_be_supplied_by_the_manufacturer\" title=\"Information to be supplied by the manufacturer\">Information to be supplied by the manufacturer<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-technical-file-checklist-the-ultimate-guide\/#Design_manufacturing_information\" title=\"Design &amp; manufacturing information\">Design &amp; manufacturing information<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-technical-file-checklist-the-ultimate-guide\/#General_safety_performance_requirements\" title=\"General safety &amp; performance requirements\">General safety &amp; performance requirements<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-technical-file-checklist-the-ultimate-guide\/#Verification_validation_information\" title=\"Verification &amp; validation information\">Verification &amp; validation information<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-technical-file-checklist-the-ultimate-guide\/#Risk_assessment\" title=\"Risk assessment\u00a0\">Risk assessment\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-technical-file-checklist-the-ultimate-guide\/#Declaration_of_Conformity\" title=\"Declaration of Conformity\">Declaration of Conformity<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-technical-file-checklist-the-ultimate-guide\/#Need_help_with_your_technical_documentation_and_MDR_compliance_Consult_medical_device_CER_writers_medical_device_regulatory_experts_and_MDR_consultants_on_Kolabtree\" title=\"Need help with your technical documentation and MDR compliance? Consult medical device CER writers, medical device regulatory experts, and MDR consultants on Kolabtree.\">Need help with your technical documentation and MDR compliance? Consult medical device CER writers, medical device regulatory experts, and MDR consultants on Kolabtree.<\/a><\/li><\/ul><\/nav><\/div>\n<p><em>The essential Technical File checklist for medical device manufacturers. Download the one-page guide to make sure you&#8217;ve got everything you need to achieve MDR compliance and get a CE mark.\u00a0<\/em><\/p>\n<p><span style=\"font-weight: 400;\">If you are a medical device manufacturer and are intending to sell your product in the European Market, than you are required to establish conformity according to the European Union Medical Device Regulation 2017\/745 ANNEX IX to XI (EU MDR 2017\/745)<\/span><b>1<\/b><span style=\"font-weight: 400;\">. You can establish this conformity by compiling documentation, known as a Technical File, to seek approval for selling your medical devices.\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Download_the_Medical_Device_Technical_File_Checklist\"><\/span>Download the Medical Device Technical File Checklist<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<div class='mailmunch-forms-short-code mailmunch-forms-widget-1073033' style='display: none !important;'><\/div>\n<p><span style=\"font-weight: 400;\">According to the MDR, the technical file is a mandatory document for all types of medical devices that has to be prepared in a clear understandable language and must be well-organized and readily-searchable. It is essential to demonstrate the safety and performance of a specific device.The Technical File acts as a documented evidence to demonstrate that a product is safe for its intended use and effectively fulfills the required purpose.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The <\/span><b>EU MDR 2017\/745 <\/b><span style=\"font-weight: 400;\">explains and defines the requirements for the medical device (Annex I)<\/span><b>2<\/b><span style=\"font-weight: 400;\"> and it also defines the requirements for the Technical File documentation (Annex II)<\/span><b>3<\/b><span style=\"font-weight: 400;\">. You can pass this conformity<\/span><a href=\"https:\/\/www.johner-institute.com\/articles\/regulatory-affairs\/and-more\/conformity-assessment\/\"> <span style=\"font-weight: 400;\">assessment<\/span><\/a><span style=\"font-weight: 400;\"> and attain approval for a medical device very easily by meeting the requirements for your TECHNICAL FILE. Essentially your file must contain the following elements.\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Device_description_specifications\"><\/span><b>Device description &amp; specifications\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">The purpose is to fully understand the product, its purpose, specifications, constituents and materials. In this document you must explain your product completely along with system of assigning the basic UDI-DI, description of your product\u2019s classification from rules in Annex VIII and how under <\/span><a href=\"https:\/\/advisera.com\/13485academy\/mdr\/classification-of-devices\/\"><span style=\"font-weight: 400;\">Article 51<\/span><\/a><span style=\"font-weight: 400;\">.<\/span><\/p>\n<ol>\n<li><b><\/b><span style=\"font-weight: 400;\"> \u00a0<\/span><b>Specifications<\/b><span style=\"font-weight: 400;\"> include product name or trade name along with the basic UDI-DI or any clear identification.<\/span><\/li>\n<li><b><\/b><span style=\"font-weight: 400;\"> \u00a0<\/span><b>Device Description<\/b><span style=\"font-weight: 400;\"> is the general description, principle of operation, technical specifications, description of any accessories or variants, key functional elements\/parts\/components\/software and composition.<\/span><\/li>\n<\/ol>\n<h2><span class=\"ez-toc-section\" id=\"Information_to_be_supplied_by_the_manufacturer\"><\/span><b>Information to be supplied by the manufacturer<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<ol>\n<li><b><\/b><span style=\"font-weight: 400;\"> \u00a0<\/span><b>INSTRUCTION FOR USE (IFU) \u2013<\/b><span style=\"font-weight: 400;\"> This document must contain your device\u2019s description &amp; specification, purpose and any warnings and precautions. Purpose of the device is the key element in the IFU. It states the intended users along with intended patient, conditions to be diagnosed\/treated\/monitored, indications, contraindications, warnings, precautions and hazards.<\/span><\/li>\n<li><b><\/b><span style=\"font-weight: 400;\"> \u00a0<\/span><b>PACKAGING &amp; LABELLING INFORMATION \u2013 <\/b><span style=\"font-weight: 400;\">Under the MDR, in this document you must explain the complete labeling and packaging information. It should also include any description relating to single-unit sales; transport packaging in case of specific management conditions and it must contain symbols for all hazards, warning, handling instructions, date of manufacture and expiry.<\/span><\/li>\n<\/ol>\n<p><span style=\"font-weight: 400;\">NOTE: It is very important that this information must be publicly available documents and must be in one of the official languages of the EU and in the language required by the Member State.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Design_manufacturing_information\"><\/span><b>Design &amp; manufacturing information<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">In this document you must outline and explain;<\/span><\/p>\n<ol>\n<li><span style=\"font-weight: 400;\">Design schematics, drawings &amp;materials utilized.<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Processes of manufacture<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Data about all sites, where design and manufacturing activities are performed. All other subcontracted steps or processes involved in the production in any way (such as sterilization, production of a particular part or accessory, or packaging) should be explained along with the full information about name and address, as well as a description of which part of the process they perform<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Quality control procedures &amp; checks<\/span><\/li>\n<\/ol>\n<p><span style=\"font-weight: 400;\">This document is prepared in correlation with ISO 13485 and contains information from procedures, <a href=\"https:\/\/www.kolabtree.com\/blog\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">research<\/a> plans, protocols, results of verification and validation, production process in detail.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"General_safety_performance_requirements\"><\/span><b>General safety &amp; performance requirements<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">This document, also called as GSPR, is mandated under Annex 1 of the MDR. It is required to provide evidence for design and production in accordance with all applicable requirements. This is compulsory to ensure its safe use and effectiveness. This document was previously known as the essential requirements checklist.\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Verification_validation_information\"><\/span><b>Verification &amp; validation information<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<ol>\n<li><b><\/b><span style=\"font-weight: 400;\"> \u00a0<\/span><b>VERIFICATION &amp; VALIDATION REPORT \u2013 <\/b><span style=\"font-weight: 400;\">Here you must explain and show documentation of Biocompatibility testing, Safety regarding chemical components, Electricity safety, Stability when stored under prescribed conditions, Sterility and Usability. The results of these test and analysis of this pre-clinical data is compiled in this report. Besides pre-clinical data, it is important to get clinical data, which can be obtained by clinical evaluation or clinical investigation. The European Commission\u2019s main emphasis is on clinical data &#8211; not just during design and development, but post-market, too.<\/span><\/li>\n<li><b><\/b><span style=\"font-weight: 400;\"> \u00a0<\/span><b>CLINICAL EVALUATION REPORTS (CER) \u2013<\/b><span style=\"font-weight: 400;\"> This report should provide a comprehensive overview of the device\u2019s design and composition, as well its intended applications. This document must elaborate the State-of-the-Art, clinical, biological and technical comparison to a device similar to the Device. Where there are similar devices present compilation of published clinical data and any relevant literature reviews is done. However, if the device is novel than the manufacturer is required to perform Clinical Studies to establish the Technical, Clinical and Biological safety and efficacy.<br \/>\n<\/span><\/li>\n<li><b style=\"font-size: 14px;\">BIOLOGICAL EVALUATION REPORT (BER) \u2013<\/b><span style=\"font-weight: 400;\"> This is a compilation of biocompatibility of each material that comes into contact with intact skin or tissue of the human body. This report is compiled in accordance with ISO 10993-1 Biocompatibility standards.<\/span><\/li>\n<li><b>HS COMPLIANCE MATRIX to ISO 10993-1:2021<\/b><b>4<\/b><b> \u2013 <\/b><span style=\"font-weight: 400;\">This document is prepared as a checklist to establish the applicable requirements under this biocompatibility standard. It also establishes the biocompatibility tests applicable on the device under ISO 10993<\/span><\/li>\n<li><b>Post-Market Clinical Follow-Up (PMCF) \u2013<\/b><span style=\"font-weight: 400;\">You are required to maintain a process to continuously update the clinical evaluation and necessitates the proactive gathering of clinical data and its evaluation,after sale of your device(outlined in Part 2 of Annex XIV)<\/span><b>5<\/b><span style=\"font-weight: 400;\">. These steps allow you to confirm the safety and performance throughout the expected lifetime of your device. This also ensures the acceptability of already identified risks and to detect emerging risks based on factual evidence.<\/span><\/li>\n<li><b>Post-Market Surveillance (PMS) plan and report\u2013<\/b><span style=\"font-weight: 400;\">The MDR requires that you as a manufacturer must maintain a compilation of clinical and safety-related data after the approval\/CE certification process and market access.\u00a0 This allows you and your Notified Body to systematically identify risks <\/span><a href=\"https:\/\/decomplix.com\/intended-purpose-medical-device\/\"><span style=\"font-weight: 400;\">in the practical use of the product<\/span><\/a><span style=\"font-weight: 400;\">, as some risks only become apparent when your medical devices are used, stored, transported or cleaned. It is a beneficial step, as it\u00a0 enables you to ensure that your devices are safe and that there are no uncontrolled risks such as defects or undetected security problems.<\/span><\/li>\n<\/ol>\n<h2><span class=\"ez-toc-section\" id=\"Risk_assessment\"><\/span><b>Risk assessment\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">The process of identification, understanding, controlling, and prevention of failures that can result in hazards from the use of your device, is called Risk Assessment. Article 10\/2 of the Regulation requires that you must establish, document, implement and maintain a product safety risk management system throughout the lifecycle of your medical device.<\/span><span style=\"font-weight: 400;\"> The detailed requirements of the system are listed in the Annex I Chapter I, points 2-9.The MDR is in alignment with EN ISO 14971:2012 and EN ISO 13485:2016<\/span><b>6<\/b><span style=\"font-weight: 400;\">. The building of a Risk Analysis Plan &amp; Report, in accordance with these two ISO standards, allows you to comply with the MDR and establish the Risk-Benefit analysis.<\/span><\/p>\n<ol>\n<li><b><\/b><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">RISK MANAGEMENT PLAN<\/span><\/li>\n<li><b><\/b><span style=\"font-weight: 400;\"> \u00a0 \u00a0 \u00a0 \u00a0 <\/span><span style=\"font-weight: 400;\">RISK MANAGEMENT REPORT<\/span><\/li>\n<\/ol>\n<h2><span class=\"ez-toc-section\" id=\"Declaration_of_Conformity\"><\/span><b>Declaration of Conformity<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">This is a mandatory document for you and an important step towards your conformity assessment. According to MDR Article 19,manufacturer or authorized representative sign, to declare that the products comply with the EU requirements including all applicable legislations and ISO harmonized standards. It contains the following information:<\/span><\/p>\n<ol>\n<li><b><\/b><span style=\"font-weight: 400;\">name and full business address or that of authorized representative<\/span><\/li>\n<li><b><\/b><span style=\"font-weight: 400;\">the product&#8217;s serial number, model or type identification<\/span><\/li>\n<li><span style=\"font-weight: 400;\">classification of the Medical Device under the MDR Annex VIII<\/span><b style=\"font-size: 14px;\">7\/8<\/b><b><\/b><\/li>\n<li><span style=\"font-weight: 400;\">a statement, stating full responsibility<\/span><b><\/b><\/li>\n<li><span style=\"font-weight: 400;\">identification of product allowing traceability \u2013 this can include an image<\/span><b><\/b><\/li>\n<li><span style=\"font-weight: 400;\">details of the notified body which carried out the <\/span><a href=\"https:\/\/europa.eu\/youreurope\/business\/product-requirements\/compliance\/conformity-assessment\/index_en.htm\"><span style=\"font-weight: 400;\">conformity assessment procedure<\/span><\/a><span style=\"font-weight: 400;\"> (if applicable)<\/span><\/li>\n<li>relevant legislation with which the product complies, as well as any <a style=\"font-size: 14px;\" href=\"https:\/\/europa.eu\/youreurope\/business\/product-requirements\/standards\/standards-in-europe\/index_en.htm\">harmonised standards<\/a><span style=\"font-weight: 400;\"> or other means used to prove compliance<\/span><\/li>\n<li>name and signature<\/li>\n<li><b><\/b><span style=\"font-weight: 400;\">date the declaration was issued<\/span><b><\/b><\/li>\n<li><span style=\"font-weight: 400;\">supplementary information (if applicable)<\/span><\/li>\n<\/ol>\n<p><span style=\"font-weight: 400;\">Thus in conclusion, you as a manufacturer must have and maintain an up-to-date Technical File, regardless of a device class, or its intended use, design, or even the safety history. These discussed essential elements that constitute the key factors of a Technical File are your easiest way towards establishing and demonstrating compliance with EU MDR 2017\/745.<\/span><\/p>\n<blockquote>\n<h4><span class=\"ez-toc-section\" id=\"Need_help_with_your_technical_documentation_and_MDR_compliance_Consult_medical_device_CER_writers_medical_device_regulatory_experts_and_MDR_consultants_on_Kolabtree\"><\/span>Need help with your technical documentation and MDR compliance? Consult <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report-cer\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=TechnicalFileChecklist\">medical device CER writers<\/a>, <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device-regulatory-writing\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=TechnicalFileChecklist\">medical device regulatory experts<\/a>, and <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device-regulations-mdr\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=TechnicalFileChecklist\">MDR consultants<\/a> on Kolabtree.<span class=\"ez-toc-section-end\"><\/span><\/h4>\n<\/blockquote>\n<p><strong>REFERENCES<\/strong><\/p>\n<ol>\n<li><span style=\"font-weight: 400;\">European Union Medical Device Regulation 2017\/745 [https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32017R0745]<\/span><\/li>\n<li><span style=\"font-weight: 400;\">ANNEX I \u2013 General safety and performance requirements [https:\/\/www.medical-device-regulation.eu\/2019\/07\/23\/annex-i-general-safety-and-performance-requirements\/]<\/span><\/li>\n<li><span style=\"font-weight: 400;\">https:\/\/www.medical-device-regulation.eu\/2019\/07\/25\/annex-ii-part-2\/<\/span><\/li>\n<li><span style=\"font-weight: 400;\">EN ISO 10993-1:2021 Biological evaluation of medical devices &#8211; Part 1: Evaluation and testing within a risk management process<\/span><\/li>\n<li><span style=\"font-weight: 400;\">ANNEX XIV Clinical evaluation and post-market clinical follow-up [https:\/\/www.medical-device-regulation.eu\/2019\/08\/14\/annex-xiv\/]<\/span><\/li>\n<li><span style=\"font-weight: 400;\">I<\/span><span style=\"font-weight: 400;\">SO 13485:2016 Medical devices \u2014 Quality management systems \u2014 Requirements for regulatory purposes [https:\/\/www.iso.org\/standard\/59752.html]<\/span><\/li>\n<li><span style=\"font-weight: 400;\">MDCG 2021-24 Guidance on classification of medical devices [https:\/\/ec.europa.eu\/health\/system\/files\/2021-10\/mdcg_2021-24_en_0.pdf]<\/span><\/li>\n<li><span style=\"font-weight: 400;\">EU MDR Annex VIII [https:\/\/www.medical-device-regulation.eu\/2019\/08\/08\/annex-viii\/<\/span><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"<p>The essential Technical File checklist for medical device manufacturers. Download the one-page guide to make sure you&#8217;ve got everything you need to achieve MDR compliance and get a CE mark.\u00a0 If you are a medical device manufacturer and are intending to sell your product in the European Market, than you are required to establish conformity<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-technical-file-checklist-the-ultimate-guide\/\" title=\"Read More\">Read More<\/a><\/div>\n","protected":false},"author":12,"featured_media":9954,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[540],"tags":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.1 (Yoast SEO v20.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Medical Device Technical File Checklist: The Ultimate Guide<\/title>\n<meta name=\"description\" content=\"Free medical device technical file checklist. 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