{"id":6395,"date":"2026-10-20T14:40:07","date_gmt":"2026-10-20T11:40:07","guid":{"rendered":"https:\/\/www.clinipower.fi\/?p=6395"},"modified":"2026-10-20T14:40:07","modified_gmt":"2026-10-20T11:40:07","slug":"mdr-technical-documentation-what-it-contains-and-how-to-maintain-it","status":"publish","type":"post","link":"https:\/\/www.clinipower.fi\/en\/mdr-technical-documentation-what-it-contains-and-how-to-maintain-it\/","title":{"rendered":"MDR Technical Documentation: What It Contains and How to Maintain It"},"content":{"rendered":"<h2 dir=\"ltr\">MDR Technical Documentation: What It Contains and How to Maintain It<\/h2>\n<p dir=\"ltr\">Technical documentation is the material a manufacturer uses to demonstrate that a medical device meets the requirements of the MDR. Its structure is defined in MDR Annexes II and III, and the manufacturer must keep it up to date throughout the device\u2019s lifecycle.<\/p>\n<h3 dir=\"ltr\">What is technical documentation?<\/h3>\n<p dir=\"ltr\">Technical documentation is material compiled and maintained by the manufacturer to demonstrate that the device meets the MDR requirements. It is a central part of conformity assessment: the notified body assesses it before CE marking, and the authorities can request it for inspection during market surveillance.<\/p>\n<p dir=\"ltr\">The basic obligation is set out in MDR Article 10: the manufacturer must draw up technical documentation and keep it up to date. The content requirements are listed in two annexes:<\/p>\n<ul dir=\"ltr\">\n<li>Annex II covers the technical documentation of the device.<\/li>\n<li>Annex III covers the technical documentation on post-market surveillance (PMS).<\/li>\n<\/ul>\n<p dir=\"ltr\">The documentation must be clear, organised, searchable and unambiguous. Its scope and depth depend on the device\u2019s risk class and complexity.<\/p>\n<h3 dir=\"ltr\">What does technical documentation include?<\/h3>\n<p dir=\"ltr\">MDR Annex II divides the documentation into six main sections. The key content of each is summarised below.<\/p>\n<div dir=\"ltr\">\n<table>\n<thead>\n<tr>\n<th scope=\"col\">Section<\/th>\n<th scope=\"col\">Topic<\/th>\n<th scope=\"col\">What it typically contains<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>1<\/td>\n<td>Device description and specification<\/td>\n<td>Device name and models, Basic UDI-DI, intended purpose, users and patient groups, indications and contraindications, principle of operation, risk class and classification rationale, variants and accessories, previous generations<\/td>\n<\/tr>\n<tr>\n<td>2<\/td>\n<td>Information supplied by the manufacturer<\/td>\n<td>Labelling, instructions for use and other information supplied with the device, in the languages required by the Member States<\/td>\n<\/tr>\n<tr>\n<td>3<\/td>\n<td>Design and manufacturing information<\/td>\n<td>Design stages, manufacturing processes and their validation, manufacturing sites, key suppliers and subcontractors<\/td>\n<\/tr>\n<tr>\n<td>4<\/td>\n<td>General safety and performance requirements (GSPR)<\/td>\n<td>Requirement-by-requirement table for Annex I: applicability, solution applied, standards and evidence<\/td>\n<\/tr>\n<tr>\n<td>5<\/td>\n<td>Benefit-risk analysis and risk management<\/td>\n<td>Benefit-risk analysis, risk management plan and report, acceptability of residual risks<\/td>\n<\/tr>\n<tr>\n<td>6<\/td>\n<td>Product verification and validation<\/td>\n<td>Pre-clinical testing (e.g. biological safety, electrical safety, EMC, software V&amp;V, shelf life) and clinical data: clinical evaluation, clinical evaluation plan and report, PMCF plan<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<p dir=\"ltr\">Section 4 works as a map of the documentation. For each requirement, the GSPR table refers to evidence in other sections, so its quality determines how easily the assessor can find what they need.<\/p>\n<p dir=\"ltr\">Note also that Sections 5 and 6 are not separate islands. Risk management, clinical evaluation and test results must refer to one another, because the assessor checks that the risks identified in the risk analysis are covered by evidence and that the clinical evaluation corresponds to them.<\/p>\n<h3 dir=\"ltr\">Post-market surveillance documentation (Annex III)<\/h3>\n<p dir=\"ltr\">Annex III is a separate part of the technical documentation. It consists mainly of the PMS plan (MDR Article 84) and either the PMS report (Article 85, class I) or the periodic safety update report, PSUR (Article 86, classes IIa, IIb and III).<\/p>\n<p dir=\"ltr\">The update frequency depends on the class:<\/p>\n<ul dir=\"ltr\">\n<li>Class I: the PMS report is updated when necessary.<\/li>\n<li>Class IIa: the PSUR is updated when necessary and at least every two years.<\/li>\n<li>Classes IIb and III: the PSUR is updated at least annually.<\/li>\n<li>For class III devices and implantable devices, a summary of safety and clinical performance must also be prepared.<\/li>\n<\/ul>\n<p dir=\"ltr\">MDCG 2025-10, published in December 2025, clarifies what a PMS system should look like. According to it, PMS is proactive and continuous, its planning starts already in the development phase, and it is part of the quality system. The PMS plan must describe the methods and data sources, and PMS data must feed back into risk management, clinical evaluation and updates to the instructions for use.<\/p>\n<p dir=\"ltr\">The PMCF plan is drawn up in accordance with Part B of MDR Annex XIV, and the data it generates is used to maintain and update the clinical evaluation. Keep these two documents aligned so that the same follow-up activity is not described differently in two places.<\/p>\n<h3 dir=\"ltr\">Maintenance, retention and the most common deficiencies<\/h3>\n<p dir=\"ltr\">Technical documentation is not a one-off package. MDR Article 10(4) requires it to be kept up to date, and Article 10(8) obliges you to retain it for at least 10 years after the last device covered by it has been placed on the market. For implantable devices, the minimum period is 15 years.<\/p>\n<p dir=\"ltr\">The need for an update arises, for example, from:<\/p>\n<ul dir=\"ltr\">\n<li>a change to the device (design, manufacturing, software version, intended purpose)<\/li>\n<li>PMS findings and new risks<\/li>\n<li>new clinical evidence or an updated clinical evaluation<\/li>\n<li>changes to standards and common specifications<\/li>\n<li>findings and nonconformities raised by the notified body<\/li>\n<\/ul>\n<p dir=\"ltr\">Notified bodies and their association, Team-NB, have published their own guidance on the structure and expectations of the documentation. Based on assessment experience, recurring deficiencies typically include the following:<\/p>\n<ol dir=\"ltr\">\n<li>The intended purpose is worded differently in different documents, for example in the instructions for use, the risk analysis and the clinical evaluation.<\/li>\n<li>The GSPR table refers to evidence in general terms rather than to specific documents and sections.<\/li>\n<li>Risk management, clinical evaluation and PMS do not refer to one another, so the flow of information cannot be traced.<\/li>\n<li>Equivalence is justified too lightly or without access to the other manufacturer\u2019s data.<\/li>\n<li>The documentation is not up to date after device changes.<\/li>\n<li>For software, lifecycle documentation, verification and cybersecurity are missing or incomplete.<\/li>\n<\/ol>\n<p dir=\"ltr\">These deficiencies can delay certification, and most of them can be prevented with a clear structure and consistent version control.<\/p>\n<h3 dir=\"ltr\">How can Clinipower help?<\/h3>\n<p dir=\"ltr\">We help manufacturers build technical documentation that is compliant, consistent and easy for the notified body to assess. We support you as needed, either throughout the whole process or at a single stage:<\/p>\n<ul dir=\"ltr\">\n<li><strong>Gap analysis.<\/strong> We review your current documentation against the requirements of Annexes II and III and compile a prioritised list of items to fix.<\/li>\n<li><strong>Documentation structure and drafting.<\/strong> We design the structure, draft the missing documents and harmonise the intended purpose, the GSPR table and the cross-references.<\/li>\n<li><strong>Software qualification and classification.<\/strong> We justify the classification on the basis of MDCG 2019-11 (software) and MDCG 2021-24 (other devices) and document it as part of the technical documentation.<\/li>\n<li><strong>Risk management.<\/strong> We help with the risk management process and files in accordance with ISO 14971 and the MDR.<\/li>\n<li><strong>Clinical evaluation and PMCF.<\/strong> We support you with the clinical evaluation plan and report as well as the PMCF plan.<\/li>\n<li><strong>PMS documentation.<\/strong> We build the PMS plan and reporting in line with the expectations of MDCG 2025-10 and link them to risk management and clinical evaluation.<\/li>\n<li><strong>Audit preparation.<\/strong> We carry out an internal review before the notified body assessment and help you respond to the assessor\u2019s findings.<\/li>\n<li><strong>Maintenance.<\/strong> We agree on change management and an update cycle so that the documentation stays up to date.<\/li>\n<\/ul>\n<p dir=\"ltr\">Whether you are bringing your first device to market or updating old documentation to meet the MDR, we can start with a small gap analysis and proceed from there according to your needs.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>MDR Technical Documentation: What It Contains and How to Maintain It Technical documentation is the material a manufacturer uses to demonstrate that a medical device meets the requirements of the MDR. Its structure is defined in MDR Annexes II and III, and the manufacturer must keep it up to date throughout the device\u2019s lifecycle. What [&#8230;]<\/p>\n<p><a class=\"btn btn-secondary understrap-read-more-link\" href=\"https:\/\/www.clinipower.fi\/en\/mdr-technical-documentation-what-it-contains-and-how-to-maintain-it\/\">Read More&#8230;<span class=\"screen-reader-text\"> from MDR Technical Documentation: What It Contains and How to Maintain It<\/span><\/a><\/p>\n","protected":false},"author":16,"featured_media":2219,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[36],"tags":[],"class_list":["post-6395","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-quality-and-regulation"],"acf":[],"gutentor_comment":0,"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>MDR Technical Documentation: What It Contains and How to Maintain It - Clinipower Finland Oy<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.clinipower.fi\/en\/mdr-technical-documentation-what-it-contains-and-how-to-maintain-it\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MDR Technical Documentation: What It Contains and How to Maintain It - Clinipower Finland Oy\" \/>\n<meta property=\"og:description\" content=\"MDR Technical Documentation: What It Contains and How to Maintain It Technical documentation is the material a manufacturer uses to demonstrate that a medical device meets the requirements of the MDR. 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