{"id":1940,"date":"2010-12-01T19:43:29","date_gmt":"2010-12-01T19:43:29","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=1940"},"modified":"2010-12-01T19:43:29","modified_gmt":"2010-12-01T19:43:29","slug":"eu-interpretative-doc-on-placing-med-devs-on-mrkt","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2010\/12\/01\/eu-interpretative-doc-on-placing-med-devs-on-mrkt\/","title":{"rendered":"EU Interpretative Doc on Placing Med Dev&#8217;s on Mrkt"},"content":{"rendered":"<p><span style=\"font-size: small;\"><span style=\"color: #333399;\"><span style=\"font-family: arial, helvetica, sans-serif;\">On 16 November 2010 this Interpretative Document was issued to explain what is considered Placing Medical Devices on the EU Market. \u00a0The document refers to all 3 medical device directives including the amendment 2007\/47\/EC. \u00a0The 3 medical device directives this applies to are Active Implantables Medical Devices <\/span><\/span><\/span><span style=\"line-height: normal;\"><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"color: #333399;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">90\/385\/EEC, Medical Devices 93\/42\/EEC, and the InVitro Diagnostic Medical Devices 98\/76\/EC. \u00a0Additionally, the biocidal products directive <\/span><\/span><\/span><\/span><\/span><\/span><\/span><span style=\"line-height: normal; font-size: 12px;\"><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"color: #333399;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">98\/8\/EC is also referenced in this document. <\/span><\/span><\/span><\/span><\/span><\/span><\/p>\n<p><span style=\"font-size: small;\"><span style=\"color: #333399;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">This document refers to the <\/span><\/span><\/span><\/span><span style=\"font-size: 13.2px;\"><a href=\"http:\/\/www.eisnersafety.com\/wp-content\/uploads\/2010\/12\/l_21820080813en00300047.pdf\"><span style=\"font-size: small;\"><span style=\"color: #333399;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">EU Directive on accreditation and market surveillance relating to the marketing of products<\/span><\/span><\/span><\/span><\/a><\/span><span style=\"font-size: 13.2px;\"><span style=\"line-height: normal; color: #1a1a18;\"><span style=\"font-size: small;\"><span style=\"color: #333399;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\"> which is EC\/<\/span><\/span><\/span><\/span><\/span><span style=\"line-height: normal; color: #1a1a18;\"><span style=\"font-size: small;\"><span style=\"color: #333399;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">765\/2008. \u00a0EC\/765\/2008 is relied on for the term &#8220;making available&#8217;.<\/span><\/span><\/span><\/span><\/span><\/span><\/p>\n<p><span style=\"line-height: normal; font-size: 12px;\"><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"color: #333399;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">The interpretative document may be viewed by clicking <\/span><\/span><\/span><\/span><\/span><\/span><span style=\"font-size: 13.2px;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\"><a href=\"http:\/\/www.eisnersafety.com\/wp-content\/uploads\/2010\/12\/placing_on_the_market_en.pdf\"><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"color: #333399;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">EU Interpretative Document &#8211; Placing Medical Devices on the Market<\/span><\/span><\/span><\/span><\/span><\/a><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"color: #333399;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">.<\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/p>\n<p><span style=\"font-size: 13.2px;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\"><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"color: #333399;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">To see a list of the current EU Medical Device Directives Interpretative Documents you can go to the <\/span><\/span><\/span><\/span><\/span><a title=\"EUROPA web page for Med Dvcs Interpretative Documents\" href=\"http:\/\/ec.europa.eu\/consumers\/sectors\/medical-devices\/documents\/interpretative-documents\/index_en.htm\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"color: #333399;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">EUROPA webpage that has the Medical Device Directives Interpretative Documents<\/span><\/span><\/span><\/span><\/span><\/a><\/span><\/span><\/span><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"color: #333399;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">.<\/span><\/span><\/span><\/span><\/span><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On 16 November 2010 this Interpretative Document was issued to explain what is considered Placing Medical Devices on the EU Market. \u00a0The document refers to all 3 medical device directives including the amendment 2007\/47\/EC. \u00a0The 3 medical device directives this<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1],"tags":[26,258,259,260,261,262,35,227,185,263,264,20,265,12,28,266,174,175,149,150,151,267,268],"class_list":["post-1940","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-200747ec","tag-90385eec","tag-9342eec","tag-9879ec","tag-988ec","tag-active-implantable-medical-devices-directive","tag-aimdd","tag-emergency-medical-devices-environment","tag-eu","tag-eu-interpretative-document","tag-in-vitro-diagnostic-directive","tag-ivd","tag-ivdd","tag-mdd","tag-mdd-amendment","tag-medical-device-directive","tag-medical-device-industry","tag-medical-device-regulatory","tag-medical-devices","tag-medical-implants","tag-medical-systems","tag-placing-on-the-market","tag-placing-on-the-market-of-medical-devices"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/1940","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/comments?post=1940"}],"version-history":[{"count":0,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/1940\/revisions"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=1940"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=1940"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=1940"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}