{"id":27745,"date":"2025-06-30T13:32:09","date_gmt":"2025-06-30T13:32:09","guid":{"rendered":"https:\/\/quickbirdmedical.com\/?post_type=news&#038;p=27745"},"modified":"2026-08-27T13:25:49","modified_gmt":"2026-08-27T13:25:49","slug":"bsi-tr-03161-deadline-june-30","status":"publish","type":"news","link":"https:\/\/quickbirdmedical.com\/en\/news\/bsi-tr-03161-deadline-june-30\/","title":{"rendered":"BSI TR-03161 Deadline on June 30 &#8211; What DiGA Manufacturers Need to Know Now"},"content":{"rendered":"<p>Anyone wanting to either keep a DiGA in the directory or have one newly listed since January 1, 2025 needs the certificate under BSI TR-03161.<\/p>\n<p>The extended grace period for manufacturers to submit it now ends on June 30. The big question: what happens to those DiGA that cannot present a certificate by then?<\/p>\n<p>What manufacturers specifically need to bear in mind now:<\/p>\n<p><strong>Listed DiGA<\/strong><br \/>\nDiGA currently listed will remain in the directory for now. As things stand today, it has not yet been determined when those DiGA will have to present the certificate.<\/p>\n<p><strong>DiGA applications under substantive review<\/strong><\/p>\n<p style=\"padding-left: 40px;\">a) If the substantive review period for your DiGA has not yet expired, the procedure continues and the BSI certificate must be presented before the review deadline expires.<\/p>\n<p style=\"padding-left: 40px;\">b) If the review period of up to six months has expired and no BSI certificate can be presented, you must withdraw the DiGA application, otherwise it risks being rejected. The reason: the BfArM gives no guarantees here that it will continue to review the DiGA if the certificate is not available. In other words, when a DiGA is resubmitted, new deficiencies may be found and the process could drag on further.<\/p>\n<p><strong>DiGA to be newly submitted from July 1, 2025 and DiGA under formal review<\/strong><br \/>\nThe certificate must be presented at the end of your formal review.<\/p>\n<p><strong>DiGA in appeal proceedings<\/strong><br \/>\nIn this case you need the certificate immediately, provided the appeal was successful.<\/p>\n","protected":false},"featured_media":0,"template":"","categories":[],"tags":[],"display":[54],"class_list":["post-27745","news","type-news","status-publish","hentry","display-display-on-news-page"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>BSI TR-03161 Deadline on June 30 - What DiGA Manufacturers Need to Know Now<\/title>\n<meta name=\"description\" content=\"DiGA manufacturers face new BSI TR-03161 certificate requirements. 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