{"id":6864,"date":"2021-02-03T15:11:42","date_gmt":"2021-02-03T15:11:42","guid":{"rendered":"https:\/\/eisnersafety.com\/?p=6864"},"modified":"2022-06-12T18:04:29","modified_gmt":"2022-06-12T18:04:29","slug":"notified-bodies-can-do-remote-audits-for-mdr-ivdr","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2021\/02\/03\/notified-bodies-can-do-remote-audits-for-mdr-ivdr\/","title":{"rendered":"Notified Bodies Can do Remote Audits for MDR &#038; IVDR"},"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\">Notified bodies can now do remote audits for the MDR and IVDR &#8212; Member states need to Notify the EU Commission of Notified Bodies not conducting on-site audits &amp; the period of time this will not be happening. So remote audits for these NBs won&#8217;t be happening immediately &#8211; but this is a big change! <a href=\"http:\/\/bit.ly\/EUCommRemoteAuditNotice\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (opens in a new tab)\">EUR-Lex &#8211; 52021XC0111(01) &#8211;<\/a><a href=\"http:\/\/bit.ly\/EUCommRemoteAuditNotice\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"  (opens in a new tab)\"> <\/a><a rel=\"noreferrer noopener\" aria-label=\"EUR-Lex - 52021XC0111(01) - EN - EUR-Lex (opens in a new tab)\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=OJ:JOC_2021_008_R_0001\" target=\"_blank\">EN &#8211; EUR-Lex<\/a> Each Competent Authority will need to review each separate NB&#8217;s justifications and procedures separately and this is a COVID-19 exemption only so this is temporary.  Once the Commission says COVID-19 crisis is over this goes away. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Follow this discussion on <a rel=\"noreferrer noopener\" aria-label=\" (opens in a new tab)\" href=\"https:\/\/www.linkedin.com\/posts\/leoeisnersafetyconsultants_eur-lex-52021xc011101-en-eur-lex-activity-6754512870802911232-mcp6\" target=\"_blank\">LinkedIn<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Notified bodies can now do remote audits for the MDR and IVDR &#8212; Member states need to Notify the EU Commission of Notified Bodies not conducting on-site audits &amp; the period of time this will not be happening. So remote<\/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":[1382,1407,1405,1370,1369,1372],"tags":[186,206,1173,1174,1332,330,1335,1336],"class_list":["post-6864","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-eu-commission","category-feb-2021","category-ivdr","category-mdr","category-medical-device-regulation","category-remote-auditing","tag-eu-commission","tag-european-commission","tag-ivdr","tag-mdr","tag-mdr-2017-745","tag-medical-device","tag-remote-audit","tag-remote-audits"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/6864","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=6864"}],"version-history":[{"count":3,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/6864\/revisions"}],"predecessor-version":[{"id":6870,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/6864\/revisions\/6870"}],"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=6864"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=6864"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=6864"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}