{"id":517775,"date":"2024-02-16T11:34:14","date_gmt":"2024-02-16T16:34:14","guid":{"rendered":"https:\/\/platohealth.ai\/mdcg-guidance-on-clinical-investigations-part-2-eu\/"},"modified":"2024-02-16T13:55:43","modified_gmt":"2024-02-16T18:55:43","slug":"mdcg-guidance-on-clinical-investigations-part-2-eu","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/mdcg-guidance-on-clinical-investigations-part-2-eu\/","title":{"rendered":"MDCG Guidance on Clinical Investigations: Part 2 | EU","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"
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\t\t\t\t <\/p><\/div>\n <\/p>\n <\/p>\n The <\/span>Medical Device Coordination Group<\/b> (MDCG), a voluntary association of national regulating authorities cooperating to improve the existing legal framework, has published a questions-and-answers document dedicated to clinical investigations. <\/span> In particular, the document provides detailed guidance on the regulatory pathways for conducting clinical investigations of medical devices in the European Union, as outlined in the Medical Device Regulation (MDR). <\/span><\/p>\n<\/div><\/div>\n \n\t\t\t<\/div>\n <\/p><\/div>\n <\/p>\n It addresses various scenarios, such as investigations for CE-marked devices and pilot stage studies, and outlines the applicable regulatory requirements.<\/span><\/p>\n <\/p>\n \t\t\t\t In summary, the present MDCG guidance provides an overview of the regulatory frameworks and considerations for conducting clinical investigations of medical devices in the EU, as per the MDR. <\/span> <\/p>\n https:\/\/health.ec.europa.eu\/system\/files\/2023-12\/mdcg_2021-6_en.pdf<\/a><\/p>\n<\/div><\/div>\n \n\t\t\t<\/div>\n <\/p><\/div>\n <\/p>\n RegDesk<\/strong><\/a> is a holistic Regulatory Information Management System that provides medical device and pharma companies with regulatory intelligence for over 120 markets worldwide. It can help you prepare and publish global applications, manage standards, run change assessments, and obtain real-time alerts on regulatory changes through a centralized platform. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Global expansion has never been this simple.<\/p>\n<\/div><\/div>\n \n\t\t\t<\/div>\n <\/p><\/div>\n <\/p><\/div>\n \t\t<\/div>\n \n\t<\/div>\n <\/p><\/div>\n <\/p>\n –><\/p>\n The new article highlights the aspects related to the existing regulatory pathway, the approach to be applied for different types and classes of medical devices, and the way the intended purpose of the device in question should be considered. Table of content The Medical Device Coordination Group (MDCG), a voluntary association of national regulating authorities […]<\/p>\n","protected":false,"gt_translate_keys":[{"key":"rendered","format":"html"}]},"author":2,"featured_media":517781,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[52],"tags":[],"acf":[],"gt_translate_keys":[{"key":"link","format":"url"}],"_links":{"self":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/517775"}],"collection":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/comments?post=517775"}],"version-history":[{"count":1,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/517775\/revisions"}],"predecessor-version":[{"id":517780,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/517775\/revisions\/517780"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media\/517781"}],"wp:attachment":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media?parent=517775"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/categories?post=517775"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/tags?post=517775"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}<\/span>\n\t\t\t<\/div>\n<\/p><\/div>\n
<\/span>Table of content<\/span><\/h2>\n<\/div><\/div>\n
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<\/span>The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be considered by the parties involved to ensure compliance with it. <\/span>
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<\/span>It is also important to mention that recommendations in the guidance could be subject to changes, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation. <\/span><\/p>\n<\/span>Regulatory Requirements<\/span><\/h2>\n
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<\/span>These investigations may have multiple objectives, such as verifying performance, clinical benefits, and safety. They can involve both CE-marked devices used outside their intended purpose and devices without a CE marking.<\/span>
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<\/span>For other devices, the authorization procedure is described in Article 70(7) point (b) of the MDR. Annex I of the document provides an overview of various pathways, including national requirements under Article 82 of the MDR.<\/span>
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<\/span>Depending on the nature of the study, different articles of the MDR apply, including Article 74 for post-market clinical follow-up investigations. <\/span>
<\/span>National legislation plays an essential role in this respect.<\/span>
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<\/span>The definition of these terms is subject to interpretation and evolution over time.<\/span><\/li>\n
<\/span>Devices intended to administer medicinal products are governed by the MDR, but integral products combining a device and a medicinal product follow different regulations.
Annex III<\/b> provides a flowchart for determining applicable requirements.<\/li>\n<\/ol>\n<\/div><\/div>\n<\/span>\n\t\t\t<\/div>\n
<\/span>Conclusion<\/b><\/span><\/h2>\n
<\/span>It emphasizes the importance of aligning investigations with device purposes and adhering to specific articles of the MDR, depending on the nature of the device subject to review and investigation conducted.<\/span><\/p>\n<\/div><\/div>\n<\/span>Source<\/span><\/h2>\n
<\/span>How Can RegDesk Help?<\/span><\/h2>\n
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