{"id":436,"date":"2014-07-22T06:00:11","date_gmt":"2014-07-22T10:00:11","guid":{"rendered":"http:\/\/rohs.ca\/news\/?p=436"},"modified":"2014-08-13T17:06:17","modified_gmt":"2014-08-13T21:06:17","slug":"rohs-takes-effect-for-medical-devices-and-control-and-monitoring-instruments-july-22-2014","status":"publish","type":"post","link":"https:\/\/rohs.ca\/news\/2014\/07\/22\/rohs-takes-effect-for-medical-devices-and-control-and-monitoring-instruments-july-22-2014\/","title":{"rendered":"RoHS Takes Effect for Medical Devices and Control and Monitoring Instruments &#8211; July 22, 2014"},"content":{"rendered":"<p>The EU RoHS Directive (2011\/65\/EU) substance restrictions and other compliance requirements come into effect today for most medical devices (category 8) and monitoring and control instruments (category 9).<\/p>\n<p>Key obligations for manufacturers to implement\/document Compliance Assurance System are:<\/p>\n<ul>\n<li>draw up the required technical documentation and carry out the internal production control procedure;<\/li>\n<li>ensure that their products have been designed and manufactured in accordance with the requirements for substance restrictions;<\/li>\n<li>ensure that procedures are in place for series production to remain in conformity;<\/li>\n<li>take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured products with the technical documentation and with the requirements of the RoHS Directive;<\/li>\n<li>EU declaration of conformity<\/li>\n<li>register of non-conforming EEE and product recalls, and keep distributors informed;<\/li>\n<li>ensure that their EEE bears a type, batch or serial number or other element allowing its identification;<\/li>\n<li>materials, components and EEE which have been tested or measured in accordance with harmonised standards demonstrating compliance, shall be presumed to comply with the requirements of the RoHS Directive<\/li>\n<\/ul>\n<p>The RoHS Directive obligates manufacturers to draw up &#8216;Technical Documentation&#8217; that demonstrates conformity prior to placing products on the EU market. The CENELEC EN 50581 standard specifies requirements for RoHS 2 technical documentation.<\/p>\n<p><a title=\"Contact ECD Compliance\" href=\"http:\/\/web.ecdcompliance.com\/contact-us\">Contact ECD Compliance<\/a> for additional information and support on RoHS compliance or for an independent assessment or guidance on your current RoHS conformity assessment procedures.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The EU RoHS Directive (2011\/65\/EU) substance restrictions and other compliance requirements come into effect today for most medical devices (category 8) and monitoring and control instruments (category 9). Key obligations for manufacturers to implement\/document Compliance Assurance System are: draw up the required technical documentation and carry out the internal production control procedure; ensure that their [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1,15,3],"tags":[],"class_list":["post-436","post","type-post","status-publish","format-standard","hentry","category-all","category-nl2014q3","category-regulations"],"_links":{"self":[{"href":"https:\/\/rohs.ca\/news\/wp-json\/wp\/v2\/posts\/436","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/rohs.ca\/news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/rohs.ca\/news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/rohs.ca\/news\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/rohs.ca\/news\/wp-json\/wp\/v2\/comments?post=436"}],"version-history":[{"count":3,"href":"https:\/\/rohs.ca\/news\/wp-json\/wp\/v2\/posts\/436\/revisions"}],"predecessor-version":[{"id":480,"href":"https:\/\/rohs.ca\/news\/wp-json\/wp\/v2\/posts\/436\/revisions\/480"}],"wp:attachment":[{"href":"https:\/\/rohs.ca\/news\/wp-json\/wp\/v2\/media?parent=436"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rohs.ca\/news\/wp-json\/wp\/v2\/categories?post=436"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rohs.ca\/news\/wp-json\/wp\/v2\/tags?post=436"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}