{"id":25146,"date":"2022-12-15T09:31:32","date_gmt":"2022-12-15T08:31:32","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=25146"},"modified":"2022-12-15T09:31:46","modified_gmt":"2022-12-15T08:31:46","slug":"uk-new-ways-of-reporting-adverse-events","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2022\/12\/15\/uk-new-ways-of-reporting-adverse-events\/","title":{"rendered":"UK: new ways of reporting adverse events"},"content":{"rendered":"<h2>Last 28<sup>th<\/sup> October,<strong> MHRA <\/strong><em>(<\/em><a href=\"https:\/\/www.gov.uk\/government\/organisations\/medicines-and-healthcare-products-regulatory-agency\" target=\"_blank\" rel=\"noopener\"><strong><em>Medicines and Healthcare products Regulatory Agency<\/em><\/strong><\/a><em>) <\/em>announced that starting from <strong>Monday,<\/strong> <strong>5<sup>th<\/sup> December 2022<\/strong>, adverse events involving Medical Devices occurring in the UK must be reported via the <strong>new<\/strong> <a href=\"https:\/\/aic.mhra.gov.uk\/\" target=\"_blank\" rel=\"noopener\"><strong>MORE portal<\/strong><\/a>.<\/h2>\n<p>The reporting and evaluation of adverse events and <a href=\"https:\/\/www.gov.uk\/guidance\/effective-field-safety-notices-fsns-guidance-for-manufacturers-of-medical-devices\" target=\"_blank\" rel=\"noopener\"><strong>FSCA (Field Safety Corrective Actions<\/strong><\/a><strong>)<\/strong> involving Medical Devices is known as the vigilance system and must be carried out, together with Periodic Summary Reports (PSRs) and Trend Reports, by the UK-based manufacturer or <a href=\"https:\/\/www.thema-med.com\/en\/services\/local-representative-and-license-holder\/uk-responsible-person-service\/\" target=\"_blank\" rel=\"noopener\"><strong>UK Responsible Person<\/strong><\/a>.<\/p>\n<p>Post-market surveillance reporting of adverse events of Medical Devices must be submitted to MHRA by registered users <strong>via the MORE portal<\/strong> with XML report uploads or via web forms within the portal or via customised API (<em>Application Programming Interface<\/em>) for direct submission from internal systems.<\/p>\n<p>The <strong>old portal<\/strong> was in function until 6 p.m. on <strong>Friday, 2<sup>nd<\/sup> December<\/strong>, from then on it became read-only. It will still be possible to access the old portal until 30<sup>th<\/sup> April 2023 to consult existing reports: however, the documents will no longer be available for consultation after this date; we therefore recommend downloading the old account\u2019s history <strong>before 30<sup>th<\/sup> April 2023<\/strong> to avoid losing important data.<\/p>\n<p>Please note that in order to access and use the new MORE portal, it is necessary for the UK-based manufacturer or UKRP to <a href=\"https:\/\/aic.mhra.gov.uk\/\" target=\"_blank\" rel=\"noopener\"><strong>register<\/strong><\/a> via MHRA and create a <strong>new MORE account<\/strong>.<\/p>\n<h3>Need you support to market your medical devices and IVDs in the UK in full compliance with regulation?<\/h3>\n<p>Choose Thema as your <a href=\"https:\/\/www.thema-med.com\/en\/services\/local-representative-and-license-holder\/uk-responsible-person-service\/\" target=\"_blank\" rel=\"noopener\"><strong>UK Responsible Person (UKRP)<\/strong><\/a>. In addition to the services defined by the MHRA regulation, you will always be up-to-date with the latest regulatory developments.<\/p>\n<p><a href=\"https:\/\/www.thema-med.com\/en\/contact-us-2\/\" target=\"_blank\" rel=\"noopener\"><strong>Contact us<\/strong><\/a> for more information.<\/p>\n<p>Source: <a href=\"https:\/\/www.gov.uk\/government\/collections\/medical-devices-guidance-for-manufacturers-on-vigilance\" target=\"_blank\" rel=\"noopener\">https:\/\/www.gov.uk\/government\/collections\/medical-devices-guidance-for-manufacturers-on-vigilance<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Last 28th October, MHRA (Medicines and Healthcare products Regulatory Agency) announced that starting from Monday, 5th December 2022, adverse events involving  [&#8230;]<\/p>\n","protected":false},"author":114,"featured_media":25143,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-25146","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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