{"id":6683,"date":"2020-03-01T02:04:01","date_gmt":"2020-03-01T02:04:01","guid":{"rendered":"https:\/\/eisnersafety.com\/?p=6683"},"modified":"2022-06-12T18:13:57","modified_gmt":"2022-06-12T18:13:57","slug":"mdcg-march-20-meeting-industry-notified-bodies-provide-feedback","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2020\/03\/01\/mdcg-march-20-meeting-industry-notified-bodies-provide-feedback\/","title":{"rendered":"MDCG March &#8217;20 Meeting &#8211; Industry &#038; Notified Bodies Provide Feedback"},"content":{"rendered":"\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"497\" src=\"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2020\/02\/EU-Flags-for-Screen-1024x497.jpg\" alt=\"\" class=\"wp-image-46\" srcset=\"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2020\/02\/EU-Flags-for-Screen-1024x497.jpg 1024w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2020\/02\/EU-Flags-for-Screen-600x291.jpg 600w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2020\/02\/EU-Flags-for-Screen-300x146.jpg 300w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2020\/02\/EU-Flags-for-Screen-768x373.jpg 768w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2020\/02\/EU-Flags-for-Screen.jpg 1400w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">The Medical Device Coordination Group (MDCG) is meeting on March 11 &amp; 12th to hold a series of meetings.  Part of these meetings includes hearing feedback from industry and Notified Bodies on stakeholder preparedness for the application of the MDR on 26 May 2020.  <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Some of the topics to be discussed include:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Updates on MDCG Subgroups<\/li><li>MDR\/IVDR Implementing Acts<\/li><li>Commission&#8217;s Progress report on Notified Bodies designation process under MDR \/IVDR  <\/li><li>EUDAMED db &#8211; state of play<\/li><li>Expert Panels &#8211; State of play on setting up of Expert Panels<\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">The MDCG will discuss three transitional provisions: <\/p>\n\n\n\n<ol class=\"wp-block-list\"><li>Guidance on significant changes [Art. 120.3 (EU) 2017\/745] with regard to devices covered by certificates according to 90\/385\/EEC or 93\/42\/EEC \u2013 <span style=\"text-decoration: underline;\">for endorsement<\/span> <\/li><li>Class I transitional provisions in Article 120 (3)(4) \u2013 <span style=\"text-decoration: underline;\">for endorsement<\/span> <\/li><li>Guidance on transitional provisions for consultations of authorities on devices containing ancillary medicinal products and on devices manufactured using TSE susceptible animal tissues \u2013 for information<\/li><\/ol>\n\n\n\n<p class=\"wp-block-paragraph\">Additionally, some interesting topics include:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Discussions on the developments with regard to guidance on MDSAP (Medical Device Single Audit Programme)<\/li><li>EU Participation in the IMDRF (International Medical Devices Regulators  Forum)<\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Draft Agendas are available here:  <a rel=\"noreferrer noopener\" aria-label=\" (opens in a new tab)\" href=\"https:\/\/ec.europa.eu\/transparency\/regexpert\/index.cfm?do=groupDetail.groupMeetingDoc&amp;docid=39334\" target=\"_blank\">11 March 2020 &#8211; MDCG (MDR\/IVDR) High Level &#8211; Draft Agenda<\/a>, <a rel=\"noreferrer noopener\" aria-label=\"11-12 March 2020 - MDCG (MDR\/IVDR) Draft Agenda (opens in a new tab)\" href=\"https:\/\/ec.europa.eu\/transparency\/regexpert\/index.cfm?do=groupDetail.groupMeetingDoc&amp;docid=39323\" target=\"_blank\">11-12 March 2020 &#8211; MDCG (MDR\/IVDR) &#8211; Draft Agenda<\/a>, and <a rel=\"noreferrer noopener\" aria-label=\"12 March 2020 - Meeting between MDCG &amp; Stakeholders MDCG (MDR\/IVDR) - Draft Agenda (opens in a new tab)\" href=\"https:\/\/ec.europa.eu\/transparency\/regexpert\/index.cfm?do=groupDetail.groupMeetingDoc&amp;docid=39327\" target=\"_blank\">12 March 2020 &#8211; Meeting between MDCG &amp; Stakeholders MDCG (MDR\/IVDR) &#8211; Draft Agenda<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Need help with regulatory, MDR, quality, or compliance support with IEC 60601 series of standards support please&nbsp;<a href=\"https:\/\/eisnersafety.com\/schedule-call\/\">schedule a call<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Medical Device Coordination Group (MDCG) is meeting on March 11 &amp; 12th to hold a series of meetings. Part of these meetings includes hearing feedback from industry and Notified Bodies on stakeholder preparedness for the application of the MDR<\/p>\n","protected":false},"author":4,"featured_media":46,"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":[1365,1377,1378,1375,1376,1370,1369],"tags":[1331,471,1173,1330,1174,32],"class_list":["post-6683","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-eu","category-eudamed","category-imdrf","category-mar-2020","category-mdcg","category-mdr","category-medical-device-regulation","tag-eudamed","tag-imdrf","tag-ivdr","tag-mdcg","tag-mdr","tag-notified-body"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/6683","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=6683"}],"version-history":[{"count":3,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/6683\/revisions"}],"predecessor-version":[{"id":6853,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/6683\/revisions\/6853"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media\/46"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=6683"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=6683"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=6683"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}