{"id":3680,"date":"2025-05-29T17:02:55","date_gmt":"2025-05-29T17:02:55","guid":{"rendered":"https:\/\/cmcmedicaldevices.com\/?p=3680"},"modified":"2025-07-18T09:58:33","modified_gmt":"2025-07-18T09:58:33","slug":"6-common-mistakes-in-mdr-technical-documentation-and-how-to-avoid-them","status":"publish","type":"post","link":"https:\/\/cmcmedicaldevices.com\/es\/6-common-mistakes-in-mdr-technical-documentation-and-how-to-avoid-them\/","title":{"rendered":"6 common mistakes in MDR technical documentation (and how to avoid them)"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><p>Creating technical documentation for MDR compliance can be challenging. Although many manufacturers believe they meet all the requirements, issues still arise during assessments. These issues often lead to delays or rejections. Therefore, understanding the most frequent mistakes is essential for a successful submission.<\/p>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_74 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">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\" aria-label=\"Alternar tabla de contenidos\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><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><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/cmcmedicaldevices.com\/es\/6-common-mistakes-in-mdr-technical-documentation-and-how-to-avoid-them\/#1_Weak_scientific_justification\" >1. Weak scientific justification<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/cmcmedicaldevices.com\/es\/6-common-mistakes-in-mdr-technical-documentation-and-how-to-avoid-them\/#2_Incomplete_or_vague_device_definition\" >2. Incomplete or vague device definition<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/cmcmedicaldevices.com\/es\/6-common-mistakes-in-mdr-technical-documentation-and-how-to-avoid-them\/#3_Risk_analysis_not_aligned_with_clinical_use\" >3. Risk analysis not aligned with clinical use<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/cmcmedicaldevices.com\/es\/6-common-mistakes-in-mdr-technical-documentation-and-how-to-avoid-them\/#4_Inadequate_clinical_strategy\" >4. Inadequate clinical strategy<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/cmcmedicaldevices.com\/es\/6-common-mistakes-in-mdr-technical-documentation-and-how-to-avoid-them\/#5_Gaps_in_verification_and_validation_testing\" >5. Gaps in verification and validation testing<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/cmcmedicaldevices.com\/es\/6-common-mistakes-in-mdr-technical-documentation-and-how-to-avoid-them\/#6_Poorly_structured_GSPR_checklist\" >6. Poorly structured GSPR checklist<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/cmcmedicaldevices.com\/es\/6-common-mistakes-in-mdr-technical-documentation-and-how-to-avoid-them\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"1_Weak_scientific_justification\"><\/span>1. Weak scientific justification<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>One frequent problem is the failure to provide a clear rationale for conformity with the General Safety and Performance Requirements (GSPR). For example, some files lack references to relevant standards or fail to link clinical data to device performance. In many cases, the explanation does not reflect a scientific approach.<\/p>\n<p><strong>Tip:<\/strong> Clearly support every claim with traceable, evidence-based documentation. In addition, reference harmonized standards where applicable and ensure consistency with the intended purpose and risk classification.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"2_Incomplete_or_vague_device_definition\"><\/span>2. Incomplete or vague device definition<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Another common issue occurs when the description of the device is unclear. Often, the documentation does not explain variants, configurations, or accessories in enough detail. As a result, reviewers may struggle to understand what exactly is covered.<\/p>\n<p><strong>Tip:<\/strong> Provide a detailed and structured description. Include configuration tables, visual diagrams, and precise naming conventions to define the scope of the file clearly.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"3_Risk_analysis_not_aligned_with_clinical_use\"><\/span>3. Risk analysis not aligned with clinical use<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Risk management reports sometimes fail to reflect real-world scenarios. Consequently, they may contradict clinical findings or overlook critical hazards. This disconnect reduces the credibility of the entire documentation.<\/p>\n<p><strong>Tip:<\/strong> Align your risk analysis with actual clinical conditions and supporting data. Furthermore, link each identified risk to mitigation strategies and post-market follow-up activities.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"4_Inadequate_clinical_strategy\"><\/span>4. Inadequate clinical strategy<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Several submissions rely too heavily on claimed equivalence or lack a well-developed Post-Market Clinical Follow-up (PMCF) plan. This significantly weakens the clinical evaluation section.<\/p>\n<p><strong>Tip:<\/strong> Use robust and specific clinical evidence. If you claim equivalence, make sure you have full access to the comparator data and demonstrate similarity from a technical, biological, and clinical standpoint.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"5_Gaps_in_verification_and_validation_testing\"><\/span>5. Gaps in verification and validation testing<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Many technical files present test results without proper explanation. For instance, some reports do not include test conditions, sample details, or clear criteria for success. This makes it harder to verify the reliability of the results.<\/p>\n<p><strong>Tip:<\/strong> Present comprehensive reports or structured summaries. Always mention the device configuration, environment, and standards used for each test.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"6_Poorly_structured_GSPR_checklist\"><\/span>6. Poorly structured GSPR checklist<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Lastly, many checklists are outdated or too general. Some do not link requirements to actual evidence. In contrast, a well-prepared checklist improves traceability and speeds up the review process.<\/p>\n<p><strong>Tip:<\/strong> Create a GSPR table that connects each requirement to specific documents, including version numbers and page references. This enhances transparency and supports your claims effectively.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span>Conclusion<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Technical documentation plays a crucial role in MDR conformity. However, recurring errors often slow down the review. By focusing on these six areas, you can make your file more consistent, clearer, and easier to evaluate. As a result, you will improve your chances of obtaining approval on the first attempt.<\/p>\n<\/div><div style=\"text-align:center;\"><a class=\"fusion-button button-flat fusion-button-default-size button-default fusion-button-default button-1 fusion-button-default-span fusion-button-default-type\" style=\"--button_margin-top:10px;--button_margin-bottom:20px;\" target=\"_blank\" rel=\"noopener noreferrer\" href=\"https:\/\/cmcmedicaldevices.com\/contact\/\"><span class=\"fusion-button-text\">Contact us for more information<\/span><\/a><\/div><div class=\"fusion-image-element \" 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data-star=\"1\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"2\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"3\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"4\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"5\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n    <\/div>\n    \n<div class=\"kksr-stars-active\" style=\"width: 142.5px;\">\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n    <\/div>\n<\/div>\n                \n\n<div class=\"kksr-legend\" style=\"font-size: 19.2px;\">\n            5\/5 - (3 votos)    <\/div>\n    <\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"gallery","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-3680","post","type-post","status-publish","format-gallery","hentry","category-sin-categorizar","post_format-post-format-gallery"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.3.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>6 Common MDR Technical File Mistakes and How to Fix Them<\/title>\n<meta name=\"description\" content=\"Learn 6 common MDR technical file mistakes and how to fix them to avoid delays and improve your chances of successful conformity assessment.\" \/>\n<meta name=\"robots\" content=\"noindex, follow\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta 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