{"id":68,"date":"2011-08-30T12:11:31","date_gmt":"2011-08-30T12:11:31","guid":{"rendered":"http:\/\/www.surgicalholdings.co.uk\/blog\/?p=68"},"modified":"2021-12-06T16:54:53","modified_gmt":"2021-12-06T16:54:53","slug":"legislation-and-medical-devices","status":"publish","type":"post","link":"https:\/\/www.surgicalholdings.co.uk\/blog\/2011\/08\/legislation-and-medical-devices\/","title":{"rendered":"Legislation and Medical Devices"},"content":{"rendered":"<p>Like all industries, the selling of Medical Devices is subject to legislation and monitoring. The law that <a href=\"https:\/\/www.surgicalholdings.co.uk\/\">Surgical Holdings<\/a> have to comply with, in order to sell Medical Devices is the European Communities Council Directive 93\/42\/EEC.<\/p>\n<p><strong>Classification<\/strong><\/p>\n<p>The Medical Devices that we sell fall into 2 categories, which are defined by the Directive. Class I reusable surgical instruments and Class II implants.<\/p>\n<p>The Directive lays down the classification rules for these two categories; Class I, which are reusable surgical instruments. They are re-usable and not left in the body, therefore the lowest risk. Implants (such as <a href=\"https:\/\/www.surgicalholdings.co.uk\/sterile-kirschner-wires.html\">Kirschner Wires<\/a>, Bone Pins, Plates and Screws) are at higher risk, at Class IIb. This is because they are implanted into the body (invasive) for a period of time (normally around 90 days), although are not active in the body, so are therefore still quite a low risk.<\/p>\n<p>Devices that are used with the central circulatory system, heart or central nervous system are of course a high risk (Class III) and would be subject to more stringent controls.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Like all industries, the selling of Medical Devices is subject to legislation and monitoring. The law that Surgical Holdings have to comply with, in order <\/p>\n<a class=\"btn-blue l-blog-post-readmore\" href=\"https:\/\/www.surgicalholdings.co.uk\/blog\/2011\/08\/legislation-and-medical-devices\/\" 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":[8,9],"class_list":["post-68","post","type-post","status-publish","format-standard","hentry","category-buying-guide","tag-medical-device","tag-medical-device-directive"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Legislation and Medical Devices - Surgical Holdings<\/title>\n<meta name=\"description\" content=\"The law that Surgical Holdings have to comply with, in order to sell Medical Devices is the European Communities Council Directive 93\/42\/EEC.\" \/>\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\/legislation-and-medical-devices\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Legislation and Medical Devices - Surgical Holdings\" \/>\n<meta property=\"og:description\" content=\"The law that Surgical Holdings have to comply with, in order to sell Medical Devices is the European Communities Council Directive 93\/42\/EEC.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.surgicalholdings.co.uk\/blog\/2011\/08\/legislation-and-medical-devices\/\" \/>\n<meta property=\"og:site_name\" content=\"Surgical Holdings\" \/>\n<meta property=\"article:published_time\" content=\"2011-08-30T12:11:31+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2021-12-06T16:54:53+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\\\/legislation-and-medical-devices\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.surgicalholdings.co.uk\\\/blog\\\/2011\\\/08\\\/legislation-and-medical-devices\\\/\"},\"author\":{\"name\":\"Daniel Coole\",\"@id\":\"https:\\\/\\\/www.surgicalholdings.co.uk\\\/blog\\\/#\\\/schema\\\/person\\\/ad7adc9ea8a7a7caef4aafdf6d823311\"},\"headline\":\"Legislation and Medical Devices\",\"datePublished\":\"2011-08-30T12:11:31+00:00\",\"dateModified\":\"2021-12-06T16:54:53+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.surgicalholdings.co.uk\\\/blog\\\/2011\\\/08\\\/legislation-and-medical-devices\\\/\"},\"wordCount\":176,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/www.surgicalholdings.co.uk\\\/blog\\\/#organization\"},\"keywords\":[\"Medical device\",\"Medical Device Directive\"],\"articleSection\":[\"Buying Guide\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/www.surgicalholdings.co.uk\\\/blog\\\/2011\\\/08\\\/legislation-and-medical-devices\\\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.surgicalholdings.co.uk\\\/blog\\\/2011\\\/08\\\/legislation-and-medical-devices\\\/\",\"url\":\"https:\\\/\\\/www.surgicalholdings.co.uk\\\/blog\\\/2011\\\/08\\\/legislation-and-medical-devices\\\/\",\"name\":\"Legislation and Medical Devices - 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