{"id":27727,"date":"2025-10-27T10:30:42","date_gmt":"2025-10-27T10:30:42","guid":{"rendered":"https:\/\/quickbirdmedical.com\/?post_type=news&#038;p=27727"},"modified":"2026-08-27T13:05:09","modified_gmt":"2026-08-27T13:05:09","slug":"rule-11-svdgv-fair-risk-classification","status":"publish","type":"news","link":"https:\/\/quickbirdmedical.com\/en\/news\/rule-11-svdgv-fair-risk-classification\/","title":{"rendered":"Rule 11: SVDGV and Partners Call for Fair Risk Classification"},"content":{"rendered":"<p class=\"mcePastedContent\">The <strong>European Commission&#8217;s feedback round<\/strong> is already the <strong>second round<\/strong> in which various <strong>stakeholders<\/strong> can submit their <strong>feedback on the classification of software under the MDR<\/strong>. The first round mainly served to identify implementation problems, while the <strong>second round<\/strong> specifically targets the clarification of <strong>requirements and suggestions for improvement<\/strong>.<\/p>\n<p class=\"mcePastedContent\">The <strong>SVDGV<\/strong>, as the joint <strong>voice of eHealth providers and supporters<\/strong> in Germany, has also submitted its feedback together with other representatives of the <strong>digital health industry<\/strong>, criticising the fact that even <strong>apps with a low risk<\/strong> to users, such as dyslexia tools, are disproportionately classified as <strong>class IIa<\/strong>. The <strong>associations<\/strong> are calling for <strong>risk-appropriate implementation<\/strong> so that DiGA become <strong>accessible to patients<\/strong> quickly and efficiently and <strong>Europe remains internationally competitive<\/strong>.<\/p>\n<p class=\"mcePastedContent last-child\">Read the joint statement at: <a href=\"https:\/\/ec.europa.eu\/info\/law\/better-regulation\/have-your-say\/initiatives\/14808-Medical-devices-and-in-vitro-diagnostics-targeted-revision-of-EU-rules\/F33073337_en\/?utm_source=quickbird_medical\">https:\/\/ec.europa.eu\/info\/law\/better-regulation\/have-your-say\/initiatives\/14808-Medical-devices-and-in-vitro-diagnostics-targeted-revision-of-EU-rules\/F33073337_en<\/a><\/p>\n","protected":false},"featured_media":0,"template":"","categories":[],"tags":[],"display":[54],"class_list":["post-27727","news","type-news","status-publish","hentry","display-display-on-news-page"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO 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