{"id":6572,"date":"2025-01-17T11:41:00","date_gmt":"2025-01-17T10:41:00","guid":{"rendered":"https:\/\/www.qtec-group.com\/verzicht-klinische-daten\/"},"modified":"2025-08-25T14:04:46","modified_gmt":"2025-08-25T12:04:46","slug":"verzicht-klinische-daten","status":"publish","type":"post","link":"https:\/\/www.qtec-group.com\/en\/verzicht-klinische-daten\/","title":{"rendered":"Waiver of clinical data to demonstrate compliance to the essential requirements in initial clinical evaluation"},"content":{"rendered":"","protected":false},"excerpt":{"rendered":"<p>A waiver of clinical data under MDR Article 61(10) is possible if the product\u2019s nature, sufficient non-clinical evidence, and risk management justify it. Instead of clinical investigations, manufacturers may rely on technical testing, pre-clinical evaluation, and performance data to demonstrate safety and compliance.<\/p>\n","protected":false},"author":24,"featured_media":6574,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[48],"tags":[],"class_list":{"0":"post-6572","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-latest-news-en"},"_links":{"self":[{"href":"https:\/\/www.qtec-group.com\/en\/wp-json\/wp\/v2\/posts\/6572","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.qtec-group.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.qtec-group.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.qtec-group.com\/en\/wp-json\/wp\/v2\/users\/24"}],"replies":[{"embeddable":true,"href":"https:\/\/www.qtec-group.com\/en\/wp-json\/wp\/v2\/comments?post=6572"}],"version-history":[{"count":2,"href":"https:\/\/www.qtec-group.com\/en\/wp-json\/wp\/v2\/posts\/6572\/revisions"}],"predecessor-version":[{"id":6577,"href":"https:\/\/www.qtec-group.com\/en\/wp-json\/wp\/v2\/posts\/6572\/revisions\/6577"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.qtec-group.com\/en\/wp-json\/wp\/v2\/media\/6574"}],"wp:attachment":[{"href":"https:\/\/www.qtec-group.com\/en\/wp-json\/wp\/v2\/media?parent=6572"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.qtec-group.com\/en\/wp-json\/wp\/v2\/categories?post=6572"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.qtec-group.com\/en\/wp-json\/wp\/v2\/tags?post=6572"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}