{"id":6446,"date":"2019-12-31T22:59:04","date_gmt":"2019-12-31T22:59:04","guid":{"rendered":"https:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=6446"},"modified":"2022-06-12T18:14:11","modified_gmt":"2022-06-12T18:14:11","slug":"mdr-ivdr-designation-2019-stats","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2019\/12\/31\/mdr-ivdr-designation-2019-stats\/","title":{"rendered":"MDR \/ IVDR  Designation 2019 Stats"},"content":{"rendered":"\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" src=\"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2020\/02\/EU-Flags-for-Screen.jpg\" alt=\"\" class=\"wp-image-6443\"\/><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>EU Commission promised 20 Designations<\/strong><\/h3>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>12 Notified Bodies Designated to MDR (9) &amp; IVDR (3*)<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>*All 3 IVDR Notified Bodies have MDR designation as well, so that can be counted as double counting.  It depends on your perspective.<\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>2 NB&#8217;s are likely to be &#8220;de-designated&#8221; (not sure of the proper term yet) end of Jan 2020 based on Brexit.  That would be BSI Assurance UK Ltd.<\/strong><\/h3>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>The EU Commission has promised more NB&#8217;s to be designated in the 1st quarter of 2020.  Let&#8217;s hope this will get us to at least 20 NB&#8217;s.<\/strong><\/h3>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Two last-minute Christmas presents were BSI Group Netherlands IVDR and Medcert&#8217;s MDR designations on 24 &amp; 25 Dec respectively.<\/strong><\/h3>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Few products have been CE marked to the MDR that have gone through a NB review process. Typically the process is taking at least a year or more.  Your quality system and  product files need to be reviewed.<\/strong><\/h3>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>You are running out of time with the transition only about 5 months away.<\/strong><\/h3>\n\n\n\n<figure class=\"wp-block-image size-large is-resized\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2020\/02\/Screen-Shot-2019-12-31-at-1.50.44-PM-768x271-1.png\" alt=\"\" class=\"wp-image-6447\" width=\"580\" height=\"204\"\/><figcaption><strong><em>Notified Bodies Designated to MDR &amp; IVDR as of 31 Dec 2019<\/em><\/strong><\/figcaption><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Not all NB&#8217;s have full coverage of the NANDO codes so check the <a rel=\"noreferrer noopener\" aria-label=\" (opens in a new tab)\" href=\"https:\/\/ec.europa.eu\/growth\/tools-databases\/nando\/index.cfm?fuseaction=directive.notifiedbody&amp;dir_id=34\" target=\"_blank\">NANDO database<\/a> (MDR link) or check with your NB.<\/strong><\/h3>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>May you have a Happy, Safe, &amp; Prosperous  New Year and may your medical device be CE Marked under the MDR in the New Year.<\/strong><\/h3>\n","protected":false},"excerpt":{"rendered":"<p>EU Commission promised 20 Designations 12 Notified Bodies Designated to MDR (9) &amp; IVDR (3*) *All 3 IVDR Notified Bodies have MDR designation as well, so that can be counted as double counting. It depends on your perspective. 2 NB&#8217;s<\/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":[1383,1380,1365,1382,1370,1369,1384,1381],"tags":[1329,185,186,1173,1174,433],"class_list":["post-6446","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-brexit","category-dec-2019","category-eu","category-eu-commission","category-mdr","category-medical-device-regulation","category-nando-db","category-notified-bodies","tag-designation","tag-eu","tag-eu-commission","tag-ivdr","tag-mdr","tag-notified-bodies"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/6446","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=6446"}],"version-history":[{"count":4,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/6446\/revisions"}],"predecessor-version":[{"id":6529,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/6446\/revisions\/6529"}],"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=6446"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=6446"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=6446"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}