{"id":164,"date":"2018-09-12T15:28:54","date_gmt":"2018-09-12T15:28:54","guid":{"rendered":"http:\/\/iso.thatwebdev1.co.uk\/?page_id=164"},"modified":"2020-07-03T11:39:24","modified_gmt":"2020-07-03T11:39:24","slug":"ce-marking","status":"publish","type":"page","link":"https:\/\/www.episodeltd.com\/standard-list\/ce-marking\/","title":{"rendered":"Product Integrity"},"content":{"rendered":"\n\t<h1>Product Integrity<\/h1>\n\t<h4>CE Marks are seen everywhere, from the iPhone through to silicone tubing used in medical devices (as one of our clients manufactures). It can be a complex issue, knowing if your products should be CE Marked, and how to go about doing it. Episode will guide you through the process.<\/h4>\n\t<h2>Related Standards<\/h2>\n\t\t\t\t<img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.episodeltd.com\/wp-content\/uploads\/2018\/09\/Group-173.png\" alt=\"Group 173\" itemprop=\"image\" height=\"85\" width=\"85\" title=\"Group 173\" onerror=\"this.style.display='none'\"  \/>\n\t<h3>BS EN 1090<\/h3>\n\t<h5>In the UK it is a legal requirement that any structural metalwork is CE marked under the Construction Products Regulations (CPR)<\/h5>\n\t\t\t<a href=\"\/bs-en-1090\" target=\"_self\" role=\"button\" rel=\"noopener noreferrer\">\n\t\t\t\t\t\t\tMORE\n\t\t\t\t\t<\/a>\n\t\t\t\t<img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.episodeltd.com\/wp-content\/uploads\/2018\/09\/Group-173.png\" alt=\"Group 173\" itemprop=\"image\" height=\"85\" width=\"85\" title=\"Group 173\" onerror=\"this.style.display='none'\"  \/>\n\t<h3>ISO 13485<\/h3>\n\t<h5>Compliance to laws in quality management systems in medical devices.<\/h5>\n<p>Incorporating MDD\/MDR<\/p>\n\t\t\t<a href=\"\/iso-13485\" target=\"_self\" role=\"button\" rel=\"noopener noreferrer\">\n\t\t\t\t\t\t\tMORE\n\t\t\t\t\t<\/a>\n\t<h2>The letters \u2018CE\u2019 and logo shown below appear on many products that are traded on the single market in the\u00a0<a href=\"https:\/\/www.gov.uk\/eu-eea\">European Economic Area (EEA).<\/a><\/h2>\n\t<p>The letters &#8220;CE&#8221; are the abbreviation of French phrase &#8220;Conformit\u00e9\u00a0Europ\u00e9ene&#8221; which means &#8220;European Conformity&#8221;.<\/p>\n<p>The CE marking is required for many products. It:<\/p>\n<ul>\n<li>shows that the manufacturer has checked that these products meet\u00a0EU safety, health or environmental requirements<\/li>\n<li>is an indicator of a product\u2019s compliance with\u00a0EU\u00a0legislation<\/li>\n<li>allows the free movement of products within the European market<\/li>\n<\/ul>\n<p>For certain categories of products, such as medical devices and structural metalwork, not only do you have to conform to the requirements summarised below, you also have to have independent certification of conformance carried out (by companies known as notification bodies). These bodies are authorised by national authorities and officially \u2018notified\u2019 to the European Commission and listed on the\u00a0<a href=\"http:\/\/ec.europa.eu\/enterprise\/newapproach\/nando\/\">NANDO\u00a0(New Approach Notified and Designated Organisations)<\/a>\u00a0database .<\/p>\n<p>By placing the CE marking on a product you are declaring, on your sole responsibility, conformity with all of the legal requirements to achieve CE marking. By doing this you are ensuring validity for that product to be sold throughout the\u00a0EEA. This also applies to products made in third countries which are sold in the\u00a0EEA\u00a0and Turkey, so if you have product manufactured outside of the EEA or Turkey you must CE Mark them. This will include rigorous controls you put in place to ensure your manufacturing partner does things correctly. .<\/p>\n\t<p>Not all products must bear the CE marking. Only those product categories subject to specific directives that provide for the CE marking are required to be CE marked (see<\/p>\n<p>CE marking does not mean that a product was made in the\u00a0EEA, but states that the product is assessed before being placed on the market. It means the product satisfies the legislative requirements to be sold there. It means that the manufacturer has checked that the product complies with all relevant essential requirements, for example health and safety requirements.<\/p>\n<p>If you are a manufacturer it is your responsibility to:<\/p>\n<ul>\n<li>carry out the conformity assessment<\/li>\n<li>set up the technical file<\/li>\n<li>issue the\u00a0EC\u00a0Declaration of Conformity (DoC)<\/li>\n<li>place CE marking on a product<\/li>\n<\/ul>\n&nbsp;<br \/>\nIf you are a distributor you must check the presence of both the CE marking and the necessary supporting documentation.\n\t\t\t<a href=\"\/standard-list\/\" target=\"_self\" role=\"button\" rel=\"noopener noreferrer\">\n\t\t\t\t\t\t\tRETURN TO SECTORS\n\t\t\t\t\t<\/a>\n","protected":false},"excerpt":{"rendered":"<p>Product Integrity CE Marks are seen everywhere, from the iPhone through to silicone tubing used in medical devices (as one of our clients manufactures). It can be a complex issue, knowing if your products should be CE Marked, and how to go about doing it. Episode will guide you through the process. Related Standards BS [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":145,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"templates\/page-builder.php","meta":{"_mi_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"_genesis_hide_title":false,"_genesis_hide_breadcrumbs":false,"_genesis_hide_singular_image":false,"_genesis_hide_footer_widgets":false,"_genesis_custom_body_class":"","_genesis_custom_post_class":"","_genesis_layout":"","footnotes":""},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v21.3 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Product Integrity - Episode Ltd<\/title>\n<meta name=\"description\" content=\"CE Marks are seen everywhere, from the iPhone trough to silicone tubing used in medical devices (as one of our clients manufactures). 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