{"id":7365,"date":"2023-10-21T21:10:44","date_gmt":"2023-10-21T21:10:44","guid":{"rendered":"https:\/\/eisnersafety.com\/?p=7365"},"modified":"2023-10-21T21:10:45","modified_gmt":"2023-10-21T21:10:45","slug":"draft-eudamed-roadmap-of-modules","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2023\/10\/21\/draft-eudamed-roadmap-of-modules\/","title":{"rendered":"Draft EUDAMED Roadmap of Modules"},"content":{"rendered":"\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"576\" src=\"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2023\/10\/md_eudamed_roadmap_en-1024x576.png\" alt=\"\" class=\"wp-image-7373\" srcset=\"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2023\/10\/md_eudamed_roadmap_en-1024x576.png 1024w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2023\/10\/md_eudamed_roadmap_en-600x337.png 600w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2023\/10\/md_eudamed_roadmap_en-300x169.png 300w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2023\/10\/md_eudamed_roadmap_en-768x432.png 768w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2023\/10\/md_eudamed_roadmap_en-1536x864.png 1536w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2023\/10\/md_eudamed_roadmap_en-2048x1152.png 2048w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">Draft EUDAMED roadmap (of modules*) was published on 20 Oct 2023 with updated timelines for each module and mandatory use dates for the MDR &amp; IVDR.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Q4\u2019 2027: Article 123 (3) (d) MDR\/113 (3) (f) IVDR<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Actor (Economic Operators register in EUDAMED; Supervising Entities has access to EUDAMED that is not public),<\/li><li>Certificates (Active, suspended, reinstated, withdrawn, refused, other restrictions on certificates),<\/li><li>MSU (Evaluation of devices on the market by Competent Authorities),<\/li><li>Vigilance (&amp; Post Market Surveillance), and<\/li><li>CI\/PS (Before a device is placed on the market &#8211; Clinical Investigation and Performance Study)<\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Q2\u2019 2029: Article 123 (3) (e) MDR\/113 (3) (a) IVDR<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Devices (Based on UDIs registered in EUDAMED) and<\/li><li>Certificates (see above)<\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">* For a brief explanation of EUDAMED modules refer to the below<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"531\" src=\"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2023\/10\/EUDAMED-Modules-1024x531.png\" alt=\"\" class=\"wp-image-7371\" srcset=\"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2023\/10\/EUDAMED-Modules-1024x531.png 1024w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2023\/10\/EUDAMED-Modules-600x311.png 600w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2023\/10\/EUDAMED-Modules-300x156.png 300w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2023\/10\/EUDAMED-Modules-768x398.png 768w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2023\/10\/EUDAMED-Modules.png 1070w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">Need help with Medical Electrical Equipment standards (60601\/80601 series) including Safety\/EMC; strategic planning for your medical electrical product lines; need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, &amp; other country regulatory requirements &amp; standards, laws, directives, and more.\u00a0<a rel=\"noreferrer noopener\" href=\"https:\/\/eisnersafety.com\/about_us\/associates\/\" target=\"_blank\">Leo Eisner<\/a>\u00a0is an expert on standards development and sits on many standards committees.\u00a0He also has experts on additional standards committees and we all talk to the regulators. He has a team of experts to support your needs. Feel free to\u00a0<a rel=\"noreferrer noopener\" href=\"http:\/\/www.eisnersafety.com\/Schedule-Call\/\" target=\"_blank\">schedule a call with Leo<\/a>\u00a0or contact Leo at\u00a0Leo@EisnerSafety.com\u00a0or through our\u00a0<a rel=\"noreferrer noopener\" href=\"https:\/\/eisnersafety.com\/contact_eisner_safety\/\" target=\"_blank\">contact form<\/a>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">We work with many test labs for Medical Electrical Safety &amp; EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Draft EUDAMED roadmap (of modules*) was published on 20 Oct 2023 with updated timelines for each module and mandatory use dates for the MDR &#038; IVDR.<\/p>\n","protected":false},"author":4,"featured_media":7373,"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":[1433,1402,1425,1346,1386,1325,1360,1359,1357,1350,1358,1353,1400,1355,1354,1356,1397,1398,1403,1440,1371,1443,1493,1445,1466,1410,1365,1382,1377,1424,1405,1427,1459,1376,1370,1461,1369,1381,1495,1431,1368,1452],"tags":[],"class_list":["post-7365","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-1433","category-1402","category-15223-1","category-60601-amendments","category-60601-series","category-60601-1","category-60601-1-a2","category-60601-1-amendment-2","category-60601-1-10","category-60601-1-11","category-60601-1-12","category-60601-1-2","category-60601-1-2-4th-ed","category-60601-1-6","category-60601-1-8","category-60601-1-9","category-1397","category-1398","category-62366-1","category-active-implants","category-auditing","category-combination-product","category-cybersecurity","category-device","category-emc","category-essential-performance","category-eu","category-eu-commission","category-eudamed","category-iso-15223-1","category-ivdr","category-labeling","category-marking","category-mdcg","category-mdr","category-medical-device","category-medical-device-regulation","category-notified-bodies","category-oct-2023","category-regulation","category-state-of-the-art","category-udi"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/7365","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=7365"}],"version-history":[{"count":5,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/7365\/revisions"}],"predecessor-version":[{"id":7376,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/7365\/revisions\/7376"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media\/7373"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=7365"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=7365"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=7365"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}