{"id":5136,"date":"2017-05-04T06:02:02","date_gmt":"2017-05-04T06:02:02","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=5136"},"modified":"2022-06-12T18:16:19","modified_gmt":"2022-06-12T18:16:19","slug":"eu-mdr-ivdr-to-be-published-in-ojeu-5-may-2017","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2017\/05\/04\/eu-mdr-ivdr-to-be-published-in-ojeu-5-may-2017\/","title":{"rendered":"EU MDR &#038; IVDR Have Been Published in OJEU 5 May 2017"},"content":{"rendered":"<p><a href=\"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2020\/02\/EU-Logo-Stylized-1.jpg\" rel=\"attachment wp-att-5124\"><img loading=\"lazy\" decoding=\"async\" class=\"alignleft wp-image-5124\" src=\"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2020\/02\/EU-Logo-Stylized-1.jpg\" alt=\"European Union\" width=\"451\" height=\"317\"><\/a><em>Update of May 5 2017 Addition of the Published Documents<br \/>\n<\/em><br \/>\n<strong><em><span style=\"color: #ff0000;\"><span style=\"color: #ff6600;\">&#8220;EU MDR &amp; IVDR were&nbsp;<\/span> <span style=\"color: #0000ff;\"><a style=\"color: #0000ff;\" href=\"http:\/\/bit.ly\/OJEU5May17\" target=\"_blank\" rel=\"nofollow noopener noreferrer\">Published in OJEU TODAY<\/a>&nbsp;<\/span><span style=\"color: #ff6600;\">Friday May 5, 2017&#8243;<\/span><\/span><\/em><\/strong><\/p>\n<p>Stop the Presses and add these earth shattering Regulations to your reading list for the next week or two:<\/p>\n<ul>\n<li><a href=\"http:\/\/bit.ly\/MDR_PubIn_OJEU_5May17\" target=\"_blank\" rel=\"nofollow noopener noreferrer\">Medical Device&nbsp;Regulation&nbsp;(EU) 2017\/745<\/a><a href=\"http:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=uriserv:OJ.L_.2017.117.01.0176.01.ENG&amp;toc=OJ:L:2017:117:TOC\" target=\"_blank\" rel=\"nofollow noopener noreferrer\">&nbsp;and<\/a><\/li>\n<li><a href=\"http:\/\/bit.ly\/IVDR_PubIn_OJEU_5May17\" target=\"_blank\" rel=\"nofollow noopener noreferrer\">In Vitro Diagnostic Regulation (EU) 2017\/746<\/a><\/li>\n<\/ul>\n<p>Bassil Akra of T\u00dcV S\u00dcD some of the <a href=\"https:\/\/www.linkedin.com\/hp\/update\/6265948789069148161\" target=\"_blank\" rel=\"noopener noreferrer\">costs of this transition in his post on LinkedIn.<\/a> It ain&#8217;t going to be cheap!<\/p>\n<p>Back to our regularly scheduled post:<\/p>\n<p>This Friday 5 May 2017 should be marked in your calendar or journal as a&nbsp;momentous date when the EU Official Journal will publish the Medical Device and In-Vitro Diagnostic Regulations and the transition periods for both start (3 years for the MDR &amp;&nbsp;5 years for the IVDR)!! &nbsp;This is the start of a turning point for many medical device and IVD manufacturers as the clock starts ticking away til the end of the transition periods of these new Regulations. &nbsp;If you haven&#8217;t started your transition planning strategies for your products&nbsp;&amp; product families the pressure should be mounting quickly as there is so much to deal with for this transition time.&nbsp;<a href=\"http:\/\/bit.ly\/EU_MDR_IVDR_FinalText\">Check out these resources for learning more about the MDR &amp; IVDR.<\/a>&nbsp;See below for some more details about the challenges you need to consider and <span style=\"color: #ff6600;\"><em><strong>START PLANNING for NOW (don&#8217;t wait)<\/strong><\/em>!<\/span><\/p>\n<p><span style=\"color: #ff6600;\"><em><strong>There is no grandfathering once the transition period ends<\/strong><\/em><\/span> for the applicable Regulation. &nbsp;So, in 3 years and a day or so if you don&#8217;t meet the MDR or 5 years &amp; a day or so if you don&#8217;t meet the IVDR you won&#8217;t&nbsp;be able to CE Mark your device and sell or&nbsp;distribute your medical or IVD device in the EU (&amp; <a href=\"http:\/\/bit.ly\/BrexitMedDvcImplications\" target=\"_blank\" rel=\"noopener noreferrer\">hopefully&nbsp;the UK which is in the middle of Brexit<\/a> implications as UK will not be part of the EU by end of transition period).<\/p>\n<p>We have talked about some of the challenges in&nbsp;the implementation of the MDR but here are more details to consider for your strategic planning:<\/p>\n<ul>\n<li>New&nbsp;definitions to deal with including nanomaterial, Unique Device Identifier, interoperability, economic operator, among other new &amp; modified definitions.<\/li>\n<li>Person Responsible for Regulatory Compliance: Identify personnel that is &nbsp;responsible for regulatory compliance with the Regulation and have a minimum work experience in the applicable device field and a minimum of academic qualifications.<\/li>\n<li>Enormous Single EU Database (not ready yet): Impacts all Economic Operators (which includes manufacturers) &#8211; Will register <em><strong>all<\/strong><\/em> devices, manufacturers, Economic Operators, CE Certificates, new clinical investigations,&nbsp;&amp; incident reporting. &nbsp;Will manage all Unique Device Identifications and Single Registration Numbers (SRN).<\/li>\n<li>Regulations are much more explicit now for the Quality Management System (QMS) &amp; Risk Management System (RMS) requirements. &nbsp;Beyond just what is in EN 13485 (ISO 1385:2016) &amp; EN 14971<\/li>\n<li>Economic Operators (new to MDR): Impacts the activities of EU Representatives, Importers, Distributors &amp; Manufacturers &#8211; Different Responsibilities depending on type of Economic Operators.<\/li>\n<li>Traceability of Devices Between Economic Operators: Between all Economic Operators (<span style=\"color: #ff6600;\"><em><strong>wow that in itself can be huge!<\/strong><\/em><\/span>) and all the way down to the healthcare institutions &amp; in some cases down to the patients devices used on.<\/li>\n<li>Annex I now called Safety &amp; Performance Requirements (not Essential Requirements): Much more prescriptive, addition of UDI &amp; SRN to labelling requirements, all manufacturers will need to update all their Annex I checklists, new Clinical Evaluation &amp; Clinical Performance Evaluations requirements<\/li>\n<li>Clinical Data: Much more prescriptive especially for higher risk class devices (class III &amp; implantable&nbsp;devices) &#8211; Clinical Investigations needed in many cases now &amp; restrictions of the type of clinical data allowed for class III devices (much more restrictive using equivalency data), post market clinical follow-up requirements for high risk class devices (i.e. annual summary reports for Class III &amp; implantable devices).<\/li>\n<li>Notified Bodies: Much more prescriptive in competency requirements, conflict of interest, designation process, etc. &nbsp;The end result is fewer Notified Bodies &amp; Notified Bodies with narrower scopes after the designation process. &nbsp;Also, with the nexus of &nbsp;the EU regulations, Canada&#8217;s MDSAP requirements, and medical device manufacturers transitioning to ISO 13485:2016 the Notified Bodies resources are being strained which means less resources available to the medical device manufacturers. The limited resources means it may be a challenge to&nbsp;complete these processes without hitting the edge or past the&nbsp;transition period so start now or you may not be able to keep all your CE medical devices on the EU market in about 3 years from now when the clock runs out.<\/li>\n<\/ul>\n<p>If you need help with your EU MDR or IVDR transition planning&nbsp;please&nbsp;email Leo Eisner at&nbsp;<a href=\"mailto:Leo at EisnerSafety dot com\">Leo at EisnerSafety dot com<\/a>, or call Leo at +1 (503)-244-6151. He is the Principal Consultant of <a href=\"http:\/\/bit.ly\/EisnerSafetyConsultants\">Eisner Safety Consultants<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Update of May 5 2017 Addition of the Published Documents &#8220;EU MDR &amp; IVDR were&nbsp; Published in OJEU TODAY&nbsp;Friday May 5, 2017&#8243; Stop the Presses and add these earth shattering Regulations to your reading list for the next week or<\/p>\n","protected":false},"author":4,"featured_media":6495,"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":[1365,1405,1406,1370,1369,1381],"tags":[185,1316,737,1323,357,1324,975,1173,1174,330,312,149,991,992,665,428,352],"class_list":["post-5136","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-eu","category-ivdr","category-may-2017","category-mdr","category-medical-device-regulation","category-notified-bodies","tag-eu","tag-eu-ivdr-transition-planning","tag-eu-medical-device-regulation","tag-eu-official-journal","tag-european-union","tag-in-vitro-diagnostic-regulation","tag-in-vitro-diagnostics","tag-ivdr","tag-mdr","tag-medical-device","tag-medical-device-regulation","tag-medical-devices","tag-official-journal","tag-oj","tag-ojeu","tag-transition","tag-transition-period"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/5136","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=5136"}],"version-history":[{"count":3,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/5136\/revisions"}],"predecessor-version":[{"id":6862,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/5136\/revisions\/6862"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media\/6495"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=5136"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=5136"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=5136"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}