{"id":2208,"date":"2011-08-31T20:24:58","date_gmt":"2011-08-31T20:24:58","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=2208"},"modified":"2011-08-31T20:24:58","modified_gmt":"2011-08-31T20:24:58","slug":"rohs-recast-implications-to-eu-med-ivd-devices","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2011\/08\/31\/rohs-recast-implications-to-eu-med-ivd-devices\/","title":{"rendered":"RoHS Recast Implications to EU Med &#038; IVD Devices"},"content":{"rendered":"<p><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">The following is provided thx to one of Eisner Safety Consultants Associates, Christine Ruther:<\/span><\/span><\/p>\n<p><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">The recast of the Restriction of Hazardous Substances (RoHS) Directive has been released as 2011\/65\/EU.\u00a0 You can read the directive at <a href=\"http:\/\/eur-lex.europa.eu\/LexUriServ\/LexUriServ.do?uri=OJ:L:2011:174:0088:0110:EN:PDF\">http:\/\/eur-lex.europa.eu\/LexUriServ\/LexUriServ.do?uri=OJ:L:2011:174:0088:0110:EN:PDF<\/a>.\u00a0 With the exception of the items listed in Article 2.4, the RoHS Directive applies to all Electrical &amp; Electronic Equipment.<\/span><\/span><\/span><\/p>\n<p><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">As an overview:<\/span><\/span><\/span><\/p>\n<p style=\"padding-left: 30px; \"><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">&#8211; \u00a0 <strong><em>Scope:<\/em><\/strong><\/span><\/span><\/span><\/p>\n<ul>\n<li>\n<ul>\n<li><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\"><strong><span style=\"color: #ff0000;\">Medical devices<\/span><\/strong><\/span><\/span><\/span> (per 93\/42\/EEC) and <strong><span style=\"color: #ff0000;\">IVD devices<\/span><\/strong> (per 90\/385\/EEC) are now <strong><span style=\"color: #ff0000;\">included<\/span><\/strong>.\u00a0 They are both part of the general group called \u201cmedical devices\u201d in the directive.<\/li>\n<li><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Active implantable medical devices remain excluded from the requirements of the directive.<\/span><\/span><\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p style=\"padding-left: 30px; \"><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">&#8211; \u00a0 <strong><em>Limits:<\/em><\/strong> The maximum concentrations in homogenous materials are limited, by weight:<\/span><\/span><\/span><\/p>\n<ul>\n<li>\n<ul>\n<li><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Lead (0.1 %)<\/span><\/span><\/span><\/li>\n<li><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Mercury (0.1 %)<\/span><\/span><\/span><\/li>\n<li><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Cadmium (0.01 %)<\/span><\/span><\/span><\/li>\n<li><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Hexavalent chromium (0.1 %)<\/span><\/span><\/span><\/li>\n<li><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Polybrominated biphenyls (PBB) (0.1 %)<\/span><\/span><\/span><\/li>\n<li><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Polybrominated diphenyl ethers (PBDE) (0.1 %)<\/span><\/span><\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p style=\"padding-left: 30px; \"><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">&#8211;\u00a0\u00a0\u00a0<strong><em>Transition:<\/em><\/strong> Devices must bear a CE mark and have a declaration of conformity for the RoHS Directive from<\/span><\/span><\/span><\/p>\n<ul>\n<li>\n<ul>\n<li><strong><span style=\"text-decoration: underline;\"><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\"><span style=\"color: #ff0000;\">22 July 2014 for Medical Devices<\/span><\/span><\/span><\/span><\/span><\/strong>.<\/li>\n<li><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\"><strong><span style=\"text-decoration: underline;\"><span style=\"color: #ff0000;\">22 July 2016 for In-Vitro Diagnostic Medical Devices<\/span><\/span><\/strong><\/span><\/span><\/span>.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p style=\"padding-left: 60px; \"><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">NOTE:\u00a0 A single CE mark and declaration are acceptable.\u00a0 (You will need to explain the dual meaning of the CE mark in the instructions for use and clarify that, if used, the Notified Body number only applies to the MDD or IVDD related issues.)<\/span><\/span><\/span><\/p>\n<p style=\"padding-left: 30px; \"><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">&#8211; \u00a0\u00a0<strong><em>Exemptions:<\/em><\/strong><\/span><\/span><\/span><\/p>\n<ul>\n<li>\n<ul>\n<li><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Cables and spare parts needed for the repair or reuse of devices may continue to be distributed for devices placed on the market prior to the transition date.<\/span><\/span><\/span><\/li>\n<li><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Exemptions available to all devices are listed in Annex III.\u00a0 Specific exemptions for medical devices are listed in Annex IV.<\/span><\/span><\/span><\/li>\n<li><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Exemptions for medical devices will be valid for up to 7 years.<\/span><\/span><\/span><\/li>\n<li><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Requests for exemptions:<\/span><\/span><\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li>\n<ul>\n<li>\n<ul>\n<li><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Will be filed with the Commission and include all information listed in Annex V.\u00a0 Most notably, the <strong>request must include an analysis of possible alternative substances, materials or designs<\/strong>.<\/span><\/span><\/span><\/li>\n<li><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Renewals must be requested at least 18 months before the existing exemption expires.<\/span><\/span><\/span><\/li>\n<li><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Applications for exemptions will be accepted for medical devices even before the RoHS Directive is fully transposed (2JAN2013) if an overseeing Notified Body certifies that the safety of potential substitute has a clear negative socioeconomic, health <span style=\"text-decoration: underline;\">and<\/span> consumer safety impacts.<\/span><\/span><\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p style=\"padding-left: 30px; \"><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">&#8211; \u00a0\u00a0<strong><em>Labeling:<\/em><\/strong> The labeling requirements are likely already addressed by MDD or IVDD requirements.\u00a0 However, you should review the requirements in Articles 7.g, 7.h9.d and 10.a to confirm.<\/span><\/span><\/span><\/p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; \"> &#8211; \u00a0\u00a0<strong><em>Record Retention:<\/em><\/strong><\/span><\/p>\n<ul style=\"padding-left: 30px; \">\n<li>\n<ul>\n<li style=\"padding-left: 30px; \"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Records must be <span style=\"color: #ff0000;\"><strong>retained for 10 years<\/strong> <\/span>after a device is placed on the market.\u00a0 Note that this may be longer than required by the MDD or IVDD.<\/span><\/span><\/li>\n<li><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Records to retain include:<\/span><\/span><\/span>\n<ul>\n<li><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Technical documentation confirming compliance with the RoHS Directive and a register of non-conforming product and product recalls,<\/span><\/span><\/span><\/li>\n<li><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">List of any economic operator (manufacturer, authorized representative, importer, distributor) who has supplied you with electrical or electronic equipment, and<\/span><\/span><\/span><\/li>\n<li><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">List of\u00a0 any economic operator to whom you have supplied any electrical or electronic equipment.<\/span><\/span><\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p style=\"padding-left: 30px; \"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">If you would like to see some additional information on some of the areas, in the future, that may be implemented refer to the \u00a0BSI article that is <a href=\"http:\/\/www.eisnersafety.com\/recasted-rohs-directive-will-apply-to-med-dvcs-ivds\/\">posted on our website<\/a>.<\/span><\/span><\/p>\n<p style=\"padding-left: 30px; \"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Our group (Eisner Safety Consultants) has worked with a select set of service providers that can obtain the CofC\u2019s or the total composition information for each component and in turn the full product composition. \u00a0Please feel free to contact me, Leo Eisner (Leo@Eisnersafety.com) if you have any questions on this subject and I would be more than happy to assist you.<\/span><\/span><\/p>\n<p style=\"padding-left: 30px; \"><span style=\"font-size: small;\"><span style=\"font-size: small;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Please <a href=\"mailto:Leo@EisnerSafety.com\" target=\"_blank\" rel=\"noopener noreferrer\">contact us<\/a> if you have questions or concerns.<\/span><\/span><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The following is provided thx to one of Eisner Safety Consultants Associates, Christine Ruther: The recast of the Restriction of Hazardous Substances (RoHS) Directive has been released as 2011\/65\/EU.\u00a0 You can read the directive at http:\/\/eur-lex.europa.eu\/LexUriServ\/LexUriServ.do?uri=OJ:L:2011:174:0088:0110:EN:PDF.\u00a0 With the exception of<\/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":[380,381,258,259,262,35,382,252,185,138,383,20,265,384,12,385,386,387,388,389,390,142,391,392],"class_list":["post-2208","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-22-july-2014","tag-22-july-2016","tag-90385eec","tag-9342eec","tag-active-implantable-medical-devices-directive","tag-aimdd","tag-cadmium","tag-ce-mark","tag-eu","tag-eu-rohs","tag-hexavalent-chromium","tag-ivd","tag-ivdd","tag-lead","tag-mdd","tag-mercury","tag-pbb","tag-pbde","tag-polybrominated-biphenyls","tag-polybrominated-diphenyl-ethers","tag-restriction-of-hazardous-substances","tag-rohs","tag-rohs-2","tag-technical-file"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/2208","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=2208"}],"version-history":[{"count":0,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/2208\/revisions"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=2208"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=2208"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=2208"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}