{"id":6898,"date":"2021-05-14T06:03:47","date_gmt":"2021-05-14T06:03:47","guid":{"rendered":"https:\/\/eisnersafety.com\/?p=6898"},"modified":"2022-06-12T18:02:56","modified_gmt":"2022-06-12T18:02:56","slug":"cen-cenelec-accepts-ecs-standardization-request","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2021\/05\/14\/cen-cenelec-accepts-ecs-standardization-request\/","title":{"rendered":"CEN & CENELEC Accepts ECs Standardization Request"},"content":{"rendered":"\n
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In my last post on this Standardization Request<\/a> I didn’t expect it to pass. I didn’t get into the politics that there was a possibility of pressure from various groups for this Standardization Request<\/a> to be accepted even if not perfect. Which it did. So, yes congratulations it passed but will we be able to get anything out of this document? Let’s hope, even though I’m not so hopeful if you read my last post<\/a>. <\/p>\n\n\n\n

So, officially we have a basis for the harmonization of the listed standards (Annex I & II) in the Standardization Request for the\u00a0MDR\u00a0and\u00a0IVDR\u00a0with CEN and CENELEC accepting the Request. The Policy Officer at the EC dealing with this is Mario Gabrielli Cossellu and he stated “This is the legal basis now in force to start publications in the\u00a0OJEU\u00a0of references of Harmonised Standards\u00a0to confer presumption of\u00a0conformity\u00a0with the legal requirements of the Regulations. The first lists should be ready by June 2021 and periodically updated and enlarged.”<\/p>\n\n\n\n

Now the BIG QUESTION is will Annex III of the Standardization Request<\/a> be able to be met for any of the Standards that are to be Harmonized and will we ever get any Harmonized Standards for the MDR & IVDR? <\/p>\n\n\n\n

In Annex III there are multiple examples: <\/p>\n\n\n\n

For the “legal requirements to be supported by the harmonised standards”<\/strong>:<\/p>\n\n\n\n

“Where a definition in a harmonised standard differs from a definition of the same term set out in Regulation (EU) 2017\/745 or Regulation (EU) 2017\/746, the differences shall be indicated in the foreword of that standard and in its Annex Z. That Annex shall also state that, for the purpose of using the standard in support of the requirements set out in Regulations (EU) 2017\/745 and (EU) 2017\/746, the definitions set out in those Regulations prevail.”<\/em><\/p>\n\n\n\n

For the “Reduction of Risk”<\/strong>:<\/p>\n\n\n\n

“The specifications of harmonised standards concerning the reduction of risk which may be associated with the device shall take into account the general requirements laid down in point 2 of Chapter I of Annex I of the MDR or IVDR to reduce risks as far as possible without adversely affecting the benefit-risk ratio.<\/strong>“<\/em><\/p>\n\n\n\n

For the “Normative References”<\/strong>:<\/p>\n\n\n\n

It’s a bloody mess and it would be hard to just repeat it all here so just look at it on your own. Realize a normative reference is a requirement whereas an Informative reference is optional and more for your information. So, in Annex III refer to Item 4.<\/p>\n\n\n\n

There is more but I’m not going to continue as this sets the scene of the crime as you can plainly see by now.<\/p>\n\n\n\n

Follow the full discussion and updates to this post on\u00a0LinkedIn<\/a><\/p>\n\n\n\n

Confused this is what Eisner Safety Consultants experts deal with all the time for countries for these and many other standards, regulations, laws, directives, and more.\u00a0Leo Eisner<\/a>\u00a0is an expert on standards development and sit on many standards committees. Let us help you through this process. Need help with Essential Performance. Feel free to schedule a call with Leo www.EisnerSafety.com\/Schedule-Call\/ or contact Leo at\u00a0Leo@EisnerSafety.com\u00a0or through our contact form at\u00a0https:\/\/eisnersafety.com\/contact_eisner_safety\/<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"

In my last post on this Standardization Request I didn’t expect it to pass. I didn’t get into the politics that there was a possibility of pressure from various groups for this Standardization Request to be accepted even if not<\/p>\n","protected":false},"author":4,"featured_media":6900,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1382,1367,1405,1420,1370,1369,1368],"tags":[],"class_list":["post-6898","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-eu-commission","category-harmonized-standards","category-ivdr","category-may-2021","category-mdr","category-medical-device-regulation","category-state-of-the-art"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/6898","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=6898"}],"version-history":[{"count":5,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/6898\/revisions"}],"predecessor-version":[{"id":6906,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/6898\/revisions\/6906"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media\/6900"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=6898"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=6898"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=6898"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}