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aria-hidden="true" data-ecl-icon><use xlink:href="/themes/contrib/oe_theme/dist/ec/images/icons/sprites/icons.svg#corner-arrow"></use></svg><span class="ecl-button__label" data-ecl-label="true">Previous items</span></span></button><button class="ecl-button ecl-button--ghost ecl-menu__item ecl-menu__items-next ecl-button--icon-only" type="button" data-ecl-menu-items-next tabindex="-1" ><span class="ecl-button__container"><svg class="ecl-icon ecl-icon--s ecl-icon--rotate-90 ecl-button__icon" focusable="false" aria-hidden="true" data-ecl-icon><use xlink:href="/themes/contrib/oe_theme/dist/ec/images/icons/sprites/icons.svg#corner-arrow"></use></svg><span class="ecl-button__label" data-ecl-label="true">Next items</span></span></button><ul class="ecl-menu__list" data-ecl-menu-list><li class="ecl-menu__item" data-ecl-menu-item id="ecl-menu-item-ecl-menu-1463751571-0"><a href="/index_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__link" data-untranslated-label="Home" data-ecl-menu-link id="ecl-menu-item-ecl-menu-1463751571-0-link" >Home</a></li><li class="ecl-menu__item ecl-menu__item--current ecl-menu__item--has-children" data-ecl-menu-item data-ecl-has-children aria-haspopup aria-expanded="false" id="ecl-menu-item-ecl-menu-1463751571-1"><a href="/single-market_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__link ecl-menu__link--current" data-untranslated-label="Single market and standards" data-ecl-menu-link id="ecl-menu-item-ecl-menu-1463751571-1-link" >Single market and standards</a><button class="ecl-button ecl-button--ghost ecl-menu__button-caret ecl-button--icon-only" type="button" data-ecl-menu-caret aria-label="Access item's children" aria-describedby="ecl-menu-item-ecl-menu-1463751571-1-link" aria-expanded="false" ><span class="ecl-button__container"><svg class="ecl-icon ecl-icon--xs ecl-icon--rotate-180 ecl-button__icon" focusable="false" aria-hidden="true" data-ecl-icon><use xlink:href="/themes/contrib/oe_theme/dist/ec/images/icons/sprites/icons.svg#corner-arrow"></use></svg></span></button><div class="ecl-menu__mega" data-ecl-menu-mega ><ul class="ecl-menu__sublist"><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/single-market/30th-anniversary_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="30th anniversary of the single market" >30th anniversary of the single market</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/single-market/single-notification-window_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="Single notification window" >Single notification window</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="https://commission.europa.eu/funding-tenders/find-funding/eu-funding-programmes/single-market-programme/overview_en" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="Single Market Programme (SMP)" >Single Market Programme (SMP)</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/single-market/goods_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="Single market for goods" >Single market for goods</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/single-market/services_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="Single market for services" >Single market for services</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/single-market/european-standards_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="European standards" >European standards</a></li><li class="ecl-menu__subitem ecl-menu__subitem--current" data-ecl-menu-subitem ><a href="/single-market/ce-marking_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink ecl-menu__sublink--current" data-untranslated-label="CE marking" aria-current="page" >CE marking</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/single-market/public-procurement_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="Public procurement" >Public procurement</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/single-market/single-market-enforcement-taskforce_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="The Single Market Enforcement Taskforce" >The Single Market Enforcement Taskforce</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/single-market/barriers-trade_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="Barriers to trade" >Barriers to trade</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/single-market/governance-and-monitoring-single-market_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="Governance and monitoring of the single market" >Governance and monitoring of the single market</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/single-market/single-digital-gateway_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="Single digital gateway" >Single digital gateway</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/single-market/single-market-strategy_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="The single market strategy" >The single market strategy</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/single-market/single-market-act_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="Single Market Act" >Single Market Act</a></li><li class="ecl-menu__subitem ecl-menu__see-all"><a href="/single-market_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-link--icon ecl-menu__sublink" ><span class="ecl-link__label">See all</span><svg class="ecl-icon ecl-icon--xs ecl-icon--rotate-180 ecl-link__icon" focusable="false" aria-hidden="true" ><use xlink:href="/themes/contrib/oe_theme/dist/ec/images/icons/sprites/icons.svg#arrow-left"></use></svg></a></li></ul></div></li><li class="ecl-menu__item ecl-menu__item--has-children" data-ecl-menu-item data-ecl-has-children aria-haspopup aria-expanded="false" id="ecl-menu-item-ecl-menu-1463751571-2"><a href="/industry_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__link" data-untranslated-label="Industry" data-ecl-menu-link id="ecl-menu-item-ecl-menu-1463751571-2-link" >Industry</a><button class="ecl-button ecl-button--ghost ecl-menu__button-caret ecl-button--icon-only" type="button" data-ecl-menu-caret aria-label="Access item's children" aria-describedby="ecl-menu-item-ecl-menu-1463751571-2-link" aria-expanded="false" ><span class="ecl-button__container"><svg class="ecl-icon ecl-icon--xs ecl-icon--rotate-180 ecl-button__icon" focusable="false" aria-hidden="true" data-ecl-icon><use xlink:href="/themes/contrib/oe_theme/dist/ec/images/icons/sprites/icons.svg#corner-arrow"></use></svg></span></button><div class="ecl-menu__mega" data-ecl-menu-mega ><ul class="ecl-menu__sublist"><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/industry/advanced-manufacturing_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="Advanced Manufacturing " >Advanced Manufacturing </a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/industry/strategy_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="European industrial strategy" >European industrial strategy</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/industry/cluster-policy_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="Cluster policy" >Cluster policy</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/industry/industrial-alliances_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="Industrial alliances" >Industrial alliances</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/industry/sustainability_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="Sustainability" >Sustainability</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/industry/transition-pathways_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="Transition pathways" >Transition pathways</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/industry/international-activities_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="International activities" >International activities</a></li><li class="ecl-menu__subitem ecl-menu__see-all"><a href="/industry_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-link--icon ecl-menu__sublink" ><span class="ecl-link__label">See all</span><svg class="ecl-icon ecl-icon--xs ecl-icon--rotate-180 ecl-link__icon" focusable="false" aria-hidden="true" ><use xlink:href="/themes/contrib/oe_theme/dist/ec/images/icons/sprites/icons.svg#arrow-left"></use></svg></a></li></ul></div></li><li class="ecl-menu__item ecl-menu__item--has-children" data-ecl-menu-item data-ecl-has-children aria-haspopup aria-expanded="false" id="ecl-menu-item-ecl-menu-1463751571-3"><a href="/smes_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__link" data-untranslated-label="Entrepreneurship and SMEs" data-ecl-menu-link id="ecl-menu-item-ecl-menu-1463751571-3-link" >Entrepreneurship and SMEs</a><button class="ecl-button ecl-button--ghost ecl-menu__button-caret ecl-button--icon-only" type="button" data-ecl-menu-caret aria-label="Access item's children" aria-describedby="ecl-menu-item-ecl-menu-1463751571-3-link" aria-expanded="false" ><span class="ecl-button__container"><svg class="ecl-icon ecl-icon--xs ecl-icon--rotate-180 ecl-button__icon" focusable="false" aria-hidden="true" data-ecl-icon><use xlink:href="/themes/contrib/oe_theme/dist/ec/images/icons/sprites/icons.svg#corner-arrow"></use></svg></span></button><div class="ecl-menu__mega" data-ecl-menu-mega ><ul class="ecl-menu__sublist"><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/smes/learn-and-plan-entrepreneurship_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="Learn and plan" >Learn and plan</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/smes/sme-fundamentals_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="SME fundamentals" >SME fundamentals</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/smes/sme-strategy-and-sme-friendly-business-conditions_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="SME-friendly business conditions" >SME-friendly business conditions</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/smes/growing-and-scaling-sme_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="Growing and scaling as an SME" >Growing and scaling as an SME</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/smes/funding-and-support_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="Funding and support" >Funding and support</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/smes/challenges-and-resilience_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="Challenges and resilience" >Challenges and resilience</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/smes/continuity-and-exit_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="Continuity and exit" >Continuity and exit</a></li><li class="ecl-menu__subitem ecl-menu__see-all"><a href="/smes_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-link--icon ecl-menu__sublink" ><span class="ecl-link__label">See all</span><svg class="ecl-icon ecl-icon--xs ecl-icon--rotate-180 ecl-link__icon" focusable="false" aria-hidden="true" ><use xlink:href="/themes/contrib/oe_theme/dist/ec/images/icons/sprites/icons.svg#arrow-left"></use></svg></a></li></ul></div></li><li class="ecl-menu__item ecl-menu__item--has-children" data-ecl-menu-item data-ecl-has-children aria-haspopup aria-expanded="false" id="ecl-menu-item-ecl-menu-1463751571-4"><a href="/access-finance_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__link" data-untranslated-label="Access to finance" data-ecl-menu-link id="ecl-menu-item-ecl-menu-1463751571-4-link" >Access to finance</a><button class="ecl-button ecl-button--ghost ecl-menu__button-caret ecl-button--icon-only" type="button" data-ecl-menu-caret aria-label="Access item's children" aria-describedby="ecl-menu-item-ecl-menu-1463751571-4-link" aria-expanded="false" ><span class="ecl-button__container"><svg class="ecl-icon ecl-icon--xs ecl-icon--rotate-180 ecl-button__icon" focusable="false" aria-hidden="true" data-ecl-icon><use xlink:href="/themes/contrib/oe_theme/dist/ec/images/icons/sprites/icons.svg#corner-arrow"></use></svg></span></button><div class="ecl-menu__mega" data-ecl-menu-mega ><ul class="ecl-menu__sublist"><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/access-finance/policy-areas_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="Policy areas" >Policy areas</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/access-finance/guide-crowdfunding_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="Guide on crowdfunding" >Guide on crowdfunding</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/access-finance/investeu_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="Invest EU" >Invest EU</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/access-finance/data-and-surveys-safe_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="Data and surveys - SAFE" >Data and surveys - SAFE</a></li><li class="ecl-menu__subitem ecl-menu__see-all"><a href="/access-finance_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-link--icon ecl-menu__sublink" ><span class="ecl-link__label">See all</span><svg class="ecl-icon ecl-icon--xs ecl-icon--rotate-180 ecl-link__icon" focusable="false" aria-hidden="true" ><use xlink:href="/themes/contrib/oe_theme/dist/ec/images/icons/sprites/icons.svg#arrow-left"></use></svg></a></li></ul></div></li><li class="ecl-menu__item ecl-menu__item--has-children" data-ecl-menu-item data-ecl-has-children aria-haspopup aria-expanded="false" id="ecl-menu-item-ecl-menu-1463751571-5"><a href="/sectors_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__link" data-untranslated-label="Sectors" data-ecl-menu-link id="ecl-menu-item-ecl-menu-1463751571-5-link" >Sectors</a><button class="ecl-button ecl-button--ghost ecl-menu__button-caret ecl-button--icon-only" type="button" data-ecl-menu-caret aria-label="Access item's children" aria-describedby="ecl-menu-item-ecl-menu-1463751571-5-link" aria-expanded="false" ><span class="ecl-button__container"><svg class="ecl-icon ecl-icon--xs ecl-icon--rotate-180 ecl-button__icon" focusable="false" aria-hidden="true" data-ecl-icon><use xlink:href="/themes/contrib/oe_theme/dist/ec/images/icons/sprites/icons.svg#corner-arrow"></use></svg></span></button><div class="ecl-menu__mega" data-ecl-menu-mega ><ul class="ecl-menu__sublist"><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/sectors/automotive-industry_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="Automotive industry" >Automotive industry</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/sectors/biotechnology_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="Biotechnology" >Biotechnology</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/sectors/chemicals_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="Chemicals" >Chemicals</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/sectors/construction_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="Construction sector" >Construction sector</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/sectors/cosmetics_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="Cosmetics" >Cosmetics</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/sectors/cultural-and-creative-industries_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="Cultural and Creative Industries" >Cultural and Creative Industries</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/sectors/electrical-and-electronic-engineering-industries-eei_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="Electrical and Electronic Engineering Industries (EEI)" >Electrical and Electronic Engineering Industries (EEI)</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/sectors/agri-food-industrial-ecosystem_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="The Agri-food Industrial Ecosystem" >The Agri-food Industrial Ecosystem</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/sectors/maritime-industries_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="Maritime industries" >Maritime industries</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/sectors/mechanical-engineering_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="Mechanical engineering" >Mechanical engineering</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/sectors/postal-services_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="Postal services" >Postal services</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/sectors/pressure-equipment-and-gas-appliances_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="Pressure equipment and gas appliances" >Pressure equipment and gas appliances</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/sectors/proximity-and-social-economy_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="Proximity and social economy ecosystem " >Proximity and social economy ecosystem </a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/sectors/raw-materials_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" data-untranslated-label="Raw materials, metals, minerals and forest-based industries" >Raw materials, metals, minerals and forest-based industries</a></li><li class="ecl-menu__subitem" data-ecl-menu-subitem ><a href="/sectors/tourism_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-menu__sublink" 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ecl-breadcrumb__icon" focusable="false" aria-hidden="true" role="presentation"><use xlink:href="/themes/contrib/oe_theme/dist/ec/images/icons/sprites/icons.svg#corner-arrow"></use></svg></li><li class="ecl-breadcrumb__segment" data-ecl-breadcrumb-item="static"><a href="/single-market/ce-marking_en?prefLang=es" class="ecl-link ecl-link--standalone ecl-link--no-visited ecl-breadcrumb__link" >CE marking</a><svg class="ecl-icon ecl-icon--fluid ecl-breadcrumb__icon" focusable="false" aria-hidden="true" role="presentation"><use xlink:href="/themes/contrib/oe_theme/dist/ec/images/icons/sprites/icons.svg#corner-arrow"></use></svg></li><li class="ecl-breadcrumb__segment ecl-breadcrumb__current-page" data-ecl-breadcrumb-item="static" aria-current="page"><span>Manufacturers</span></li></ol></nav><div class="ecl-page-header__info"><h1 class="ecl-page-header__title"><span>Manufacturers</span></h1></div></div></div> </div> <main class="ecl-u-pb-xl" id="main-content" data-inpage-navigation-source-area="h2.ecl-u-type-heading-2, div.ecl-featured-item__heading"> <div class="ecl-container"> <div class="ecl-row"> <div class="ecl-col-s-12 ewcms-top-sidebar"> <div> <div data-drupal-messages-fallback class="hidden"></div> </div> </div> </div> <div class="ecl-row"> <div class="ecl-col-s-12"> <div id="block-ewcms-theme-main-page-content" data-inpage-navigation-source-area="h2, div.ecl-featured-item__heading" class="ecl-u-mb-l"> <article dir="ltr"> <div> <div class="ecl-u-mb-2xl"> <a id="paragraph_277"></a> <div class="ecl"><p><strong>Manufacturers play a crucial role in ensuring that products placed on the extended single market of the European Economic Area (EEA) are safe. They are responsible for checking that their products meet EU safety, health, performance and environmental protection requirements. It is the manufacturer’s responsibility to carry out the conformity assessment, set up the technical documentation, issue the EU declaration of conformity, and affix the CE marking to a product. Only then can this product be traded on the EEA market.</strong></p><p>If you are a manufacturer, you have to follow these 6 steps to affix a CE marking to your product</p><ol type="1"><li><strong>Identify the applicable directive(s) / regulation(s) and </strong><a href="https://single-market-economy.ec.europa.eu/single-market/european-standards_en"><strong>harmonised standards</strong></a></li></ol><p>The directives and regulations aligned with, or based on the reference provisions of <a href="http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32008D0768&locale=en">Decision 768/2008/EC</a>, are listed <a href="https://single-market-economy.ec.europa.eu/single-market/goods/new-legislative-framework_en">here</a>.</p><ol type="1" start="2"><li><strong>Verify product specific requirements</strong></li></ol><p>EU legislative acts based on the ‘new approach’ and ‘new legislative framework’ policies, providing for the CE marking, have been designed in such a manner that they cover, within their respective scope, all requirements for products from each of the sectors. However, it is possible that more than one regulation or directive applies to the same product. Furthermore, other EU legislation (such as horizontal legislation on chemicals or on the environment) can apply.</p><ol type="1" start="3"><li><strong>Identify whether an independent </strong><a href="https://single-market-economy.ec.europa.eu/single-market/goods/building-blocks/conformity-assessment_en"><strong>conformity assessment</strong></a><strong> (by a notified body) is necessary</strong></li></ol><p>For products that present higher risks, the manufacturer cannot check safety alone. In these cases, an independent organisation, specifically a notified body appointed by national authorities, has to perform the safety check. The manufacturer may only affix the CE marking to the product after this.</p><p>To find the notified bodies appointed by the EU countries to carry out conformity assessment, please use <a href="https://webgate.ec.europa.eu/single-market-compliance-space/home">NANDO</a> – the ‘new approach notified and designated organisations’ database, where you can search for notified bodies by legislation or by country.</p><ol type="1" start="4"><li><strong>Test the product and check its conformity</strong></li></ol><p>A notified body verifies, in most cases, both the quality management of the manufacturer, the design of the product and its compliance with the ‘essential requirements’. The manufacturer may also choose another conformity assessment route. In that route, the notified body verifies the product type for the conformity with the essential requirements and the conformity of the final products with the type. After successfully completing the assessment, the notified body issues (a) certificate(s) indicating what has been verified.</p><p>The manufacturer must draw up the EU declaration of conformity (DoC) to declare his sole responsibility for the conformity to the relevant regulation or directive. The DoC must include the manufacturer’s details such as name and address, essential characteristics of the product, if applicable the identification number of the notified body as well as a legally binding signature on behalf of the organisation.</p><ol type="1" start="5"><li><strong>Draw up and keep available the required technical documentation</strong></li></ol><p>Prior to submission of an application to the notified body or, at the latest, when placing the first device of the respective type on the market, the manufacturer must establish the technical documentation. The technical documents must enable the assessment of the conformity of the appliance with the requirements of the legislation.</p><p>The manufacturer or his authorised representative established in the European Union is required to keep copies of the technical documentation for a period specified in the applicable regulation or directive.</p><ol type="1" start="6"><li><strong>Affix the </strong><a href="https://single-market-economy.ec.europa.eu/single-market/ce-marking_en"><strong>CE marking</strong></a><strong> and draw up the </strong><a href="https://ec.europa.eu/docsroom/documents/9781/attachments/1/translations"><strong>EU declaration of conformity</strong></a><strong> (27 KB)</strong></li></ol><p>Once the necessary steps have been successfully completed, the CE marking must be affixed to the medical device. The CE marking must be placed visibly and legibly on the product or, if not possible due to the nature of the product, be affixed to the packaging and the accompanying document. The CE marking shall consist of the initials 'CE' taking the form below.</p> <div class="ecl-media-container ecl-media-container--custom-ratio ecl-u-mb-s ewcms-embed-small" data-ecl-media-container="true" data-ecl-auto-init="MediaContainer"><figure class="ecl-media-container__figure"><div class="ecl-media-container__media"><img loading="eager" class="ecl-u-width-100 ecl-u-height-auto ecl-media-container__media--ratio-custom" srcset="/sites/default/files/styles/embed_small/public/2024-08/CE_graduated.jpg?itok=dQGqiI2s 1x, /sites/default/files/styles/embed_small_2x/public/2024-08/CE_graduated.jpg?itok=1a2NnFE7 2x" width="190" height="112" src="/sites/default/files/styles/embed_small/public/2024-08/CE_graduated.jpg?itok=dQGqiI2s" alt="EU CE mark graduated"></div></figure></div> <p>The various components of the CE marking must have the same vertical dimension, and may not be smaller than 5 mm. If the CE marking is reduced or enlarged, the proportions given in the above graduated drawing must be respected.</p><p>When the product is subject to other EU regulations or directives covering other aspects and which also provide for the CE marking, the accompanying documents must indicate that the product also conforms to those other legislative acts.</p><p>If a notified body has been involved in the conformity assessment procedure, its identification number must also be displayed.</p><p>These 6 steps may differ by product as the conformity assessment procedure varies. 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