{"id":2725,"date":"2012-08-31T23:56:13","date_gmt":"2012-08-31T23:56:13","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=2725"},"modified":"2012-08-31T23:56:13","modified_gmt":"2012-08-31T23:56:13","slug":"update-to-eu-harmonized-standards-of-the-mdd-aimdd-ivdd","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2012\/08\/31\/update-to-eu-harmonized-standards-of-the-mdd-aimdd-ivdd\/","title":{"rendered":"Update to EU Harmonized Standards of the MDD, AIMDD, & IVDD"},"content":{"rendered":"

On 30 Aug 2012 the EU Commission released updated lists of Harmonized Standards for the Medical Device Directive<\/a>, the Active Implantable\u00a0Directive<\/a>, and the In-Vitro Diagnostic\u00a0Directive<\/a>.
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All 3 of these directives included new EN versions of EN SIO 13485:2012\/AC:2012 (replacing EN ISO 13485:2003) and EN ISO 14971:2012 (replacing EN ISO 14971:2009). \u00a0Both have had changes done only to the Informative Annexes ZA, ZB, & ZC which are only in the European versions of ISO 13485 & ISO 14971. \u00a0Informative means it is not a mandatory requirement. \u00a0I am guessing, like many of us in the regulatory field why the transition period is 0 (there is no transition period from the previous version of these standards to the new version of the standard), is that since the changes are only in the Informative sections of the EN standard. \u00a0The sections that are Normative (requirements) haven’t changed from what the ISO versions of the standards are (being ISO 13485:2003 and ISO 14971:2007).<\/span><\/p>\n

The <\/span>Annexes ZA, ZB, & ZC cover the Relationship between the European Standard and the Conformity Assessment Requirements of the EU for each of these 3 directives. \u00a0These Annexes are the way it is supposed show how the the clauses of the standard (ISO 13485 & ISO 14971) either meet or don’t meet the specific Directives.<\/span><\/p>\n

From my experience as a Notifed Body Auditor I expect the Notified Bodies (NB’s) will be issuing new certificates but I wouldn’t expect it for free. \u00a0Since this will impact many companies within a short time span (probably in the next year or so) I think the NB’s will figure out a way to make the new certificates be issued based on when other changes are required for the certificates which will be for multiple different situations that already exist (such as when a company moves across the street, or they add a new technology, etc., etc.). \u00a0<\/span><\/p>\n

ISO 14971 seems like this may be a bit more of a problem as the Annexes says many things that many would disagree with (such as ALARP is not considered acceptable anymore). \u00a0But it is in the Informative Section of the standard (just like in EN ISO 13485:2012\/AC:2012) so I don’t see a way the NB’s will be able to push this on the manufacturers as it is in the Informative section of the standard and so is not a mandatory requirement. \u00a0More to come on this over time as things get better clarified.\u00a0<\/span><\/p>\n

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On 30 Aug 2012 the EU Commission released updated lists of Harmonized Standards for the Medical Device Directive, the Active Implantable\u00a0Directive, and the In-Vitro Diagnostic\u00a0Directive.<\/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":[],"class_list":["post-2725","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/2725","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=2725"}],"version-history":[{"count":0,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/2725\/revisions"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=2725"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=2725"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=2725"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}