Technical documentation is the evidence file that the manufacturer must compile and maintain on an ongoing basis to demonstrate a product\u2019s conformity with Regulation (EU) 2017\/745. Its content is set out in Annex II, and the documentation on post-market surveillance in Annex III. It forms the basis for every conformity assessment, every regulatory review, and every product release, and must reflect the actual state of the product throughout its entire lifecycle. Its core purpose is an umbrella function: it brings the individual technical evidence documents together into a consistent chain of argumentation. <\/p>\n
Annex II specifies six sections. Section 1 contains the product description and specification, including variants and accessories, including intended purpose, Basic UDI-DI, target patient population, indications and contraindications, mode of action, justification that the product is a medical device, the risk class with justification of the applied classification rule, novel features, materials in contact with the body, and technical specifications; it also includes information on previous and similar generations. Section 2 covers labelling and instructions for use in the accepted languages. Section 3 describes design and manufacturing, including process validation, as well as all sites, suppliers, and subcontractors. <\/p>\n
Section 4 requires a comparison against the general safety and performance requirements, including the method applied, the harmonised standards or common specifications applied, and a reference to the respective evidence. Section 5 contains the benefit\u2013risk analysis and risk management, and Section 6 verification and validation with preclinical and clinical data. <\/p>\n
Formally, Annex III is a separate file and, in practice, the second part of the same documentation. Section 1 requires the post-market surveillance plan in accordance with Article 84, including the information sources to be evaluated, the indicators and thresholds for re-evaluating the benefit\u2013risk ratio, the methodology for trend reporting under Article 88, the communication channels with authorities, users, and distributors, the procedures for corrective and preventive actions, and the plan for post-market clinical follow-up in accordance with Annex XIV Part B, or a justification as to why such a plan is not required. Section 2 lists the post-market surveillance report under Article 85 and the periodic safety update report under Article 86 as components. <\/p>\n
The technical documentation does not contain the technical evidence as a pile of appendices, but as a linked system. The risk management file under Annex I Section 3 feeds into Section 5; the clinical evaluation report together with the evaluation plan under Article 61(12) and Annex XIV Part A feeds into Section 6.1(c); the biological evaluation of medical devices and the evidence for electrical safety, electromagnetic compatibility, software, sterility, and shelf life feed into the remaining parts of Section 6.1. The comparison under Section 4 acts as an index: for each of the general safety and performance requirements, it must be stated whether it is applicable, by which method it is met, and where the evidence is located. Inconsistencies between intended purpose, instructions for use, risk analysis, and clinical data are the most common reason for objections, because they become visible at this point. <\/p>\n
Technical documentation is product-specific and contains the evidence itself. The EU Declaration of Conformity is the legal declaration derived from it and comprises only a few pages with the information required under Annex IV. A certificate issued by a Notified Body merely confirms the outcome of an assessment; it does not replace the documentation and, at most, is appended to it. The CE marking is the visible consequence, not a component. Technical documentation differs from the quality management system in that the latter describes processes across the organisation, whereas the documentation consolidates the results for a specific product or product group. The Notified Body also assesses both separately: the system under Annex IX Chapter I, and the product-specific documentation under Chapter II. <\/p>\n
Clinical investigations generate a substantial part of the content of Section 6. The clinical investigation report, raw data availability, event assessments, and the resulting changes to the instructions for use, contraindications, and risk analysis must be prepared in such a way that they can be incorporated into the documentation and remain consistent there with the intended purpose. Conversely, the existing documentation provides the input parameters for the application for authorisation under Annex XV, in particular the preclinical data and the risk analysis. <\/p>\n
Under Article 10(8), the documentation must be retained for at least ten years, and for implantable devices fifteen years, after the last product has been placed on the market; study documentation must be archived accordingly. Full-service CROs such as Mediconomics support manufacturers in transferring study results into the technical documentation in a structured manner and in demonstrably maintaining consistency between clinical data, risk management, and intended purpose. <\/p>\n
Does a Class I product also require technical documentation?<\/strong><\/p>\n Yes. Under Article 52(7), the manufacturer may declare the conformity of a Class I product only after having prepared the documentation in accordance with Annexes II and III. The scope differs; the obligation does not. <\/p>\n Must the documentation be available in the national language?<\/strong><\/p>\n The language requirements prescribed by the Regulation primarily relate to labelling, instructions for use, and the Declaration of Conformity. For the remaining parts, the respective Member State determines the accepted language; the Notified Body\u2019s practice must also be taken into account. <\/p>\n How often must the documentation be updated?<\/strong><\/p>\n Continuously. Triggers include product and process changes, new clinical or preclinical data, results from post-market surveillance, and amended standards or legal bases. <\/p>\n Technical documentation is the evidence file that the manufacturer must compile and maintain on an ongoing basis to demonstrate a product\u2019s conformity with Regulation (EU) 2017\/745. Its content is set out in Annex II, and the documentation on post-market surveillance in Annex III. It forms the basis for every conformity assessment, every regulatory review, and […]<\/p>\n","protected":false},"author":10,"featured_media":0,"parent":0,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"glossary-cat":[24],"class_list":["post-7762","glossary","type-glossary","status-publish","hentry","glossary-cat-medizinprodukte-ivd"],"acf":[],"related_terms":"","external_url":"","internal_reference_id":"","_links":{"self":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/7762","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary"}],"about":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/types\/glossary"}],"author":[{"embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/users\/10"}],"version-history":[{"count":0,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/7762\/revisions"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=7762"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=7762"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Regulatory References<\/h2>\n
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