{"id":253394,"date":"2023-11-03T07:26:53","date_gmt":"2023-11-03T11:26:53","guid":{"rendered":"https:\/\/platohealth.ai\/eda-guidance-on-reporting-adverse-reactions-responsibilities-of-users-regdesk\/"},"modified":"2023-11-03T14:43:23","modified_gmt":"2023-11-03T18:43:23","slug":"eda-guidance-on-reporting-adverse-reactions-responsibilities-of-users-regdesk","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/eda-guidance-on-reporting-adverse-reactions-responsibilities-of-users-regdesk\/","title":{"rendered":"EDA Guidance on Reporting Adverse Reactions: Responsibilities of Users – RegDesk","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"
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The article highlights the key points related to the responsibilities of persons using healthcare products in the context of reporting adverse reactions thereto. <\/span><\/p>\n<\/div><\/div>\n

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<\/span>Table of content<\/span><\/h2>\n<\/div><\/div>\n

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The article highlights the key points related to the responsibilities of persons using healthcare products in the context of reporting adverse reactions thereto. <\/span><\/p>\n

The <\/span>Egyptian Drug Authority<\/span><\/a> (EDA), the country\u2019s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to detecting and reporting adverse reactions to drugs and medical devices. <\/span><\/p>\n

The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by manufacturers, distributors, and other parties involved in order to ensure continuous safety of healthcare products allowed for marketing and use in the country. <\/span><\/p>\n

The authority also reserves the right to make changes to the guidance, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation. <\/span><\/p>\n

The scope of the guidance covers, inter alia, the aspects related to the responsibilities of users.<\/span><\/p>\n<\/div><\/div>\n

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<\/span>User Responsibilities within the Vigilance System<\/b><\/span><\/h2>\n

First of all, the authority emphasizes that the Vigilance System, designed to monitor and address potential issues with medical devices, heavily relies on the active participation of users. According to the guidance, this includes:<\/span><\/p>\n