{"id":32920,"date":"2026-04-06T12:34:42","date_gmt":"2026-04-06T12:34:42","guid":{"rendered":"https:\/\/devmsite2.manualdevelopment.com\/?p=32920"},"modified":"2026-04-07T13:36:21","modified_gmt":"2026-04-07T13:36:21","slug":"drafting-a-declaration-of-conformity","status":"publish","type":"post","link":"https:\/\/www.manualise.com\/en\/drafting-a-declaration-of-conformity\/","title":{"rendered":"Drafting a Declaration of Conformity"},"content":{"rendered":"\n<p class=\"button-main button-main_dark-blue is-style-outline mb-5\"><a href=\"\/en\/contact\/\">Contact us directly \u2192<\/a><\/p>\n\n\n\n<div class=\"wp-block-columns position-relative single-post-line is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column padding-divider is-layout-flow wp-block-column-is-layout-flow\"><\/div>\n<\/div>\n\n\n\n<h4 class=\"wp-block-heading\">Table of Contents<\/h4>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column page-single-post_anchers is-layout-flow wp-block-column-is-layout-flow\">\n<p><span style=\"font-weight: 400;\"><a href=\"#What-Is-a-Declaration-of-Conformity\">What Is a Declaration of Conformity<\/a>\u00a0<\/span><\/p>\n<p><a href=\"#Why-Is-a-Declaration-of-Conformity-Mandatory\"><span style=\"font-weight: 400;\">Why Is a Declaration of Conformity Mandatory<\/span><\/a><\/p>\n<p><span style=\"font-weight: 400;\"><a href=\"#When-Should-You-Draft-a-Declaration-of-Conformity\">When Should You Draft a Declaration of Conformity<\/a>\u00a0<\/span><\/p>\n<p><a href=\"#How-a-Declaration-of-Conformity-Is-Structured\"><span style=\"font-weight: 400;\">How a Declaration of Conformity Is Structured\u00a0<\/span><\/a><\/p>\n<p><span style=\"font-weight: 400;\"><a href=\"#Role-of-the-Notified-Body\">Role of the Notified Body<\/a>\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\"><a href=\"#Requirements-for-Manuals-and-Documentation\">Requirements for Manuals and Documentation<\/a>\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\"><a href=\"#Step-by-Step-Plan-for-Drafting-the-Declaration\">Step-by-Step Plan for Drafting the Declaration<\/a>\u00a0<\/span><\/p>\n<p><a href=\"#Support-from-an-Expert\"><span style=\"font-weight: 400;\">Support from an Expert<\/span><\/a><\/p>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-columns position-relative single-post-line is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column padding-divider is-layout-flow wp-block-column-is-layout-flow\"><\/div>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"What-Is-a-Declaration-of-Conformity\">What Is a Declaration of Conformity<\/h2>\n\n\n\n<p>A declaration of conformity is an official document in which a manufacturer or their authorised representative declares that a product complies with all relevant European directives. These directives, such as the Machinery Directive or the Low Voltage Directive, are established by the European Union and implemented into national legislation by each Member State. This creates a consistent level of safety and quality for products placed on the EU market.<\/p>\n\n\n\n<p>The manufacturer or authorised representative draws up the declaration of conformity. An authorised representative is a party formally appointed in writing by the manufacturer to fulfil certain obligations on their behalf. This may, for example, be an importer.<\/p>\n\n\n\n<p>The declaration of conformity confirms that the product has been assessed in accordance with all applicable directives. This ensures that the product can be used safely and does not pose a risk to users, third parties or the environment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"Why-Is-a-Declaration-of-Conformity-Mandatory\">Why Is a Declaration of Conformity Mandatory<\/h2>\n\n\n\n<p>Drafting a declaration of conformity is not optional. Under European legislation, it is mandatory for many product groups that fall under CE directives. Without a correct declaration of conformity, a product may not carry the CE marking and cannot be placed on the European market.<\/p>\n\n\n\n<p>A declaration of conformity ensures transparency and control. It allows verification that the product meets the required standards. It also ensures that you, as a manufacturer or importer, remain responsible for the safety and compliance of the product.<\/p>\n\n\n\n<p>An incorrect or incomplete declaration of conformity may lead to sanctions. These can range from fines to withdrawal of the product from the market. In serious cases, criminal prosecution may occur, for example if false declarations have been made deliberately.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"When-Should-You-Draft-a-Declaration-of-Conformity\">When Should You Draft a Declaration of Conformity<\/h2>\n\n\n\n<p>Drafting a declaration of conformity is required for products that fall under one or more CE directives. Examples include machinery, toys, electrical equipment, personal protective equipment and medical devices. In some cases, only one directive applies, while in others multiple directives are relevant. It is therefore essential to determine in advance which directives apply to your product.<\/p>\n\n\n\n<p>Example<strong>:<\/strong> A wood chipper falls under the Machinery Directive, but may also fall under the Noise Emission Directive for outdoor equipment. In that case, both directives must be included in the declaration of conformity.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"How-a-Declaration-of-Conformity-Is-Structured\">How a Declaration of Conformity Is Structured<\/h2>\n\n\n\n<p>The content and structure of a declaration of conformity depend on the product and applicable directives. However, several elements are included in almost every declaration:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Product identification<\/strong>: Provide a clear description of the product, including type, model and any serial numbers\u00a0<\/li>\n\n\n\n<li><strong>Name and address of manufacturer\/authorised representative<\/strong>: State the details of the party issuing and signing the declaration\u00a0<\/li>\n\n\n\n<li><strong>Applicable directive(s)<\/strong>: List all European directives and regulations on which the declaration is based\u00a0<\/li>\n\n\n\n<li><strong>Applied standards<\/strong>: Indicate which harmonised standards and technical specifications have been used\u00a0<\/li>\n\n\n\n<li><strong>Notified Body involvement (if applicable)<\/strong>: If a notified body has been involved, include its name or identification number\u00a0<\/li>\n\n\n\n<li><strong>Date and place of issue<\/strong>: State when and where the declaration was signed\u00a0<\/li>\n\n\n\n<li><strong>Signature of an authorised person<\/strong>: The declaration must be signed by the manufacturer or authorised representative\u00a0<\/li>\n<\/ul>\n\n\n\n<p>The declaration of conformity is a standalone document. Test reports, the technical file and the manual form part of the complete technical documentation. This documentation must be available to supervisory authorities.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"Role-of-the-Notified-Body\">Role of the Notified Body<\/h2>\n\n\n\n<p>For some products, assessment by an external notified body is mandatory. This depends on the conformity assessment procedures, which vary by directive. For certain medical devices, for example, independent verification is required. The name and identification number of the notified body must be included in the declaration of conformity.<\/p>\n\n\n\n<p>For many products, however, an internal assessment by the manufacturer is sufficient.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"Requirements-for-Manuals-and-Documentation\">Requirements for Manuals and Documentation<\/h2>\n\n\n\n<p>In addition to drafting a declaration of conformity, you are required to provide a manual and a technical file. The manual must be understandable for the intended user and written in the language(s) of the country where the product is sold. The international standard IEC 82079 provides useful guidance, although it is not legally mandatory.<\/p>\n\n\n\n<p>The technical file includes the declaration of conformity as well as test reports, risk assessments, design drawings and relevant communication with notified bodies. This file does not need to be supplied with the product, but must be readily available for inspection by authorities.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"Step-by-Step-Plan-for-Drafting-the-Declaration\">Step-by-Step Plan for Drafting the Declaration<\/h2>\n\n\n\n<p>Below you will find a practical step-by-step plan for drafting a declaration of conformity:<\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-layout-4 wp-block-columns-is-layout-flex wp-container-core-columns-is-layout-9d6595d7\">\n<div class=\"wp-block-column single-guide fs-20 lh-39 is-layout-flow wp-block-column-is-layout-flow pb-2\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<ol class=\"wp-block-list\">\n<li><strong>Determine the product group:<\/strong><br>Identify the category to which your product belongs\u00a0<\/li>\n\n\n\n<li><strong>Identify applicable CE directives<\/strong><br>Consult the official European Commission website to find all relevant directives\u00a0<\/li>\n\n\n\n<li><strong>Assess the product<\/strong><br>Verify that the product meets the requirements of the applicable directive(s)\u00a0<\/li>\n\n\n\n<li><strong>Arrange external assessment if required<\/strong><br>Determine whether involvement of a notified body is mandatory\u00a0<\/li>\n\n\n\n<li><strong>Draft the declaration of conformity<\/strong><br>Use a template that complies with legal requirements\u00a0<\/li>\n\n\n\n<li><strong>Complete the technical file<\/strong><br>Add all relevant documents to the technical file\u00a0<\/li>\n\n\n\n<li><strong>Affix the CE marking<\/strong><br><\/li>\n<\/ol>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<p>It is not permitted to affix a CE marking without a completed and signed declaration of conformity.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Important Tips<\/h3>\n\n\n\n<p>Below are a few additional tips:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Always check whether more than one directive applies to your product\u00a0<\/li>\n\n\n\n<li>Consult current European legislation, as the number of CE directives may change\u00a0<\/li>\n\n\n\n<li>Use reliable sources, such as the European Commission and national authorities\u00a0<\/li>\n\n\n\n<li>Ensure that all information in the declaration of conformity is accurate and up to date\u00a0<\/li>\n\n\n\n<li>Retain the technical file for at least ten years after placing the product on the market (this period may vary per product)\u00a0<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"Support-from-an-Expert\">Support from an Expert<\/h2>\n\n\n\n<p>By drafting a correct declaration of conformity, you lay the foundation for safe, accessible and legally compliant products. Manualise is happy to support you in preparing your declaration of conformity. If you have any questions or would like more information, please contact one of our specialists.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Contact us directly \u2192 Table of Contents What Is a Declaration of Conformity\u00a0 Why Is a Declaration of Conformity Mandatory When Should You Draft a Declaration of Conformity\u00a0 How a Declaration of Conformity Is Structured\u00a0 Role of the Notified Body\u00a0 Requirements for Manuals and Documentation\u00a0 Step-by-Step Plan for Drafting the Declaration\u00a0 Support from an Expert [&#8230;]<\/p>\n<p><a class=\"btn btn-secondary understrap-read-more-link\" href=\"https:\/\/www.manualise.com\/en\/drafting-a-declaration-of-conformity\/\">Read More&#8230;<span class=\"screen-reader-text\"> from Drafting a Declaration of Conformity<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[292],"tags":[],"class_list":["post-32920","post","type-post","status-publish","format-standard","hentry","category-law-and-legislation-conformity"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Drafting a Declaration of Conformity - Manualise<\/title>\n<meta name=\"description\" content=\"Drafting a declaration of conformity? 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