{"id":1028,"date":"2020-06-16T12:54:25","date_gmt":"2020-06-16T12:54:25","guid":{"rendered":"https:\/\/medconcap.com\/clinical-evaluation"},"modified":"2022-04-28T13:10:16","modified_gmt":"2022-04-28T13:10:16","slug":"clinical-evaluation","status":"publish","type":"page","link":"https:\/\/medconcap.com\/en\/medical-product-advice\/clinical-evaluation","title":{"rendered":"Clinical Evaluation"},"content":{"rendered":"\n<p>Medical device manufacturers are required to have their products <strong>clinically evaluated<\/strong> or updated to meet the requirements of the MDR.<\/p>\n\n<p>The clinical evaluation is critically reviewed against available product data and serves the following <strong>objective(s)<\/strong>:<\/p>\n\n<ol class=\"wp-block-list\"><li>The manufacturer must demonstrate that the<strong>clinical benefit of the medical device(s)<\/strong> is sufficient. Depending on the <strong>risik class<\/strong> of the device, the literature route or the conduct of a clinical trial may be chosen for the clinical evaluation.<\/li><li>Manufacturers must ensure that their medical devices do <strong>not<\/strong> cause <strong>unexpected and unacceptable adverse reactions<\/strong>.<\/li><li>The appropriate <strong>purpose<\/strong>\/ claims of the manufacturer must be proven.<\/li><\/ol>\n<div class=\"wp-block-columns are-vertically-aligned-center is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:5%\">\n<figure class=\"wp-block-image size-large is-resized\"><a href=\"https:\/\/medconcap.com\/en\/contact\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/medconcap.com\/wp-content\/uploads\/2021\/04\/kontakt-Icon.png\" alt=\"Contact\" class=\"wp-image-749\" width=\"36\" height=\"58\"\/><\/a><\/figure><\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\">\n<p><strong><a href=\"http:\/\/medconcap.com\/kontakt\">Contact us<\/a> for individual and tailor-made information!<\/strong><\/p>\n<\/div>\n<\/div>\n\n<p><\/p>\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Medical device manufacturers are required to have their products clinically evaluated or updated to meet the requirements of the MDR. The clinical evaluation is critically reviewed against available product data and serves the following objective(s): The manufacturer must demonstrate that theclinical benefit of the medical device(s) is sufficient. Depending on the risik class of the [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":1044,"menu_order":-2,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"class_list":["post-1028","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/medconcap.com\/en\/wp-json\/wp\/v2\/pages\/1028","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medconcap.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/medconcap.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/medconcap.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/medconcap.com\/en\/wp-json\/wp\/v2\/comments?post=1028"}],"version-history":[{"count":7,"href":"https:\/\/medconcap.com\/en\/wp-json\/wp\/v2\/pages\/1028\/revisions"}],"predecessor-version":[{"id":1086,"href":"https:\/\/medconcap.com\/en\/wp-json\/wp\/v2\/pages\/1028\/revisions\/1086"}],"up":[{"embeddable":true,"href":"https:\/\/medconcap.com\/en\/wp-json\/wp\/v2\/pages\/1044"}],"wp:attachment":[{"href":"https:\/\/medconcap.com\/en\/wp-json\/wp\/v2\/media?parent=1028"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}