{"id":93,"date":"2011-08-30T15:28:20","date_gmt":"2011-08-30T15:28:20","guid":{"rendered":"http:\/\/www.surgicalholdings.co.uk\/blog\/?p=93"},"modified":"2021-12-06T14:12:20","modified_gmt":"2021-12-06T14:12:20","slug":"ce-marking-on-surgical-instruments-what-should-you-be-looking-for","status":"publish","type":"post","link":"https:\/\/www.surgicalholdings.co.uk\/blog\/2011\/08\/ce-marking-on-surgical-instruments-what-should-you-be-looking-for\/","title":{"rendered":"CE marking on Surgical Instruments \u2013 what should you be looking for?"},"content":{"rendered":"<p>The recent Panorama programme on <a href=\"https:\/\/www.surgicalholdings.co.uk\/\">surgical instruments<\/a> highlighted the fact that to achieve the CE mark, you can effectively self-certificate. By registering in the UK with the MHRA, you can be given a registration number and start CE marking. When purchasing from companies who CE mark their instruments, they should still have a series of technical documents, known as technical files, should they be required by the MHRA.<\/p>\n<p>Without these documents, the necessary steps have not been taken<br \/>\nto ensure the instruments are safe to go on the market. As a basic, each device<br \/>\nshould have:<\/p>\n<ul>\n<li>a technical file &#8211; which specifies its<br \/>\ndescription, the justification for the instruments being Class I<\/li>\n<li>Product list with reference to technical<br \/>\ndescriptions<\/li>\n<li>Essential requirements checklist completed<br \/>\nagainst 93\/42\/EEC<\/li>\n<li>Risk analysis that complies with 14971: 2007<\/li>\n<li>Copies of product labels that comply with BS<br \/>\nEN 980<\/li>\n<li>Relevant instruction for use for cleaning<\/li>\n<li>Declaration of Conformity<\/li>\n<\/ul>\n<p>If a medical device has not addressed the Essential Requirements,<br \/>\nit is not fit to go on the market. It may be an idea for ask to see the above<br \/>\ndocuments, or ask if they are available. Most companies will be happy to<br \/>\nprovide this information.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The recent Panorama programme on surgical instruments highlighted the fact that to achieve the CE mark, you can effectively self-certificate. By registering in the UK <\/p>\n<a class=\"btn-blue l-blog-post-readmore\" href=\"https:\/\/www.surgicalholdings.co.uk\/blog\/2011\/08\/ce-marking-on-surgical-instruments-what-should-you-be-looking-for\/\" title=\"Read more\">Read more<\/a>","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6],"tags":[20,19,11,46],"class_list":["post-93","post","type-post","status-publish","format-standard","hentry","category-buying-guide","tag-essential-requirements","tag-risk-analysis","tag-surgical-instrument","tag-surgical-instruments"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>CE Markings on Surgical Instruments - Surgical Holdings<\/title>\n<meta name=\"description\" content=\"When purchasing from companies that CE mark instruments, they should still have the technical files should they be required by the MHRA.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.surgicalholdings.co.uk\/blog\/2011\/08\/ce-marking-on-surgical-instruments-what-should-you-be-looking-for\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CE Markings on Surgical Instruments - Surgical Holdings\" \/>\n<meta property=\"og:description\" content=\"When purchasing from companies that CE mark instruments, they should still have the technical files should they be required by the MHRA.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.surgicalholdings.co.uk\/blog\/2011\/08\/ce-marking-on-surgical-instruments-what-should-you-be-looking-for\/\" \/>\n<meta property=\"og:site_name\" content=\"Surgical Holdings\" \/>\n<meta property=\"article:published_time\" content=\"2011-08-30T15:28:20+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2021-12-06T14:12:20+00:00\" \/>\n<meta name=\"author\" content=\"Daniel Coole\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Daniel Coole\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.surgicalholdings.co.uk\\\/blog\\\/2011\\\/08\\\/ce-marking-on-surgical-instruments-what-should-you-be-looking-for\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.surgicalholdings.co.uk\\\/blog\\\/2011\\\/08\\\/ce-marking-on-surgical-instruments-what-should-you-be-looking-for\\\/\"},\"author\":{\"name\":\"Daniel Coole\",\"@id\":\"https:\\\/\\\/www.surgicalholdings.co.uk\\\/blog\\\/#\\\/schema\\\/person\\\/ad7adc9ea8a7a7caef4aafdf6d823311\"},\"headline\":\"CE marking on Surgical Instruments \u2013 what should you be looking for?\",\"datePublished\":\"2011-08-30T15:28:20+00:00\",\"dateModified\":\"2021-12-06T14:12:20+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.surgicalholdings.co.uk\\\/blog\\\/2011\\\/08\\\/ce-marking-on-surgical-instruments-what-should-you-be-looking-for\\\/\"},\"wordCount\":205,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/www.surgicalholdings.co.uk\\\/blog\\\/#organization\"},\"keywords\":[\"Essential Requirements\",\"Risk analysis\",\"Surgical Instrument\",\"Surgical Instruments\"],\"articleSection\":[\"Buying Guide\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/www.surgicalholdings.co.uk\\\/blog\\\/2011\\\/08\\\/ce-marking-on-surgical-instruments-what-should-you-be-looking-for\\\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.surgicalholdings.co.uk\\\/blog\\\/2011\\\/08\\\/ce-marking-on-surgical-instruments-what-should-you-be-looking-for\\\/\",\"url\":\"https:\\\/\\\/www.surgicalholdings.co.uk\\\/blog\\\/2011\\\/08\\\/ce-marking-on-surgical-instruments-what-should-you-be-looking-for\\\/\",\"name\":\"CE Markings on Surgical Instruments - 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