{"id":22888,"date":"2022-08-10T17:08:42","date_gmt":"2022-08-10T15:08:42","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=22888"},"modified":"2022-08-11T09:11:20","modified_gmt":"2022-08-11T07:11:20","slug":"uk-possible-extension-of-validity-of-ce-marking","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2022\/08\/10\/uk-possible-extension-of-validity-of-ce-marking\/","title":{"rendered":"UK: possible extension of CE marking validity"},"content":{"rendered":"<p>In order to avoid a blockage of healthcare supplies in the territory, <strong>MHRA<\/strong> (Medicines and Healthcare products Regulatory Agency) is considering the possibility to postpone the requirement for affixing of the UKCA marking under certain unavoidable conditions.<\/p>\n<p>The scenario proposed as a result of the aforementioned assessment would amend of what has already been published within the <a href=\"https:\/\/www.gov.uk\/guidance\/regulating-medical-devices-in-the-uk\"><em>Regulating medical devices in the UK<\/em><\/a> guideline updated last January, which set <strong>June 30, 2023<\/strong> as the final and mandatory deadline for affixing the UKCA mark.<\/p>\n<p>As reflected in the document <a href=\"https:\/\/assets.publishing.service.gov.uk\/government\/uploads\/system\/uploads\/attachment_data\/file\/1085333\/Government_response_to_consultation_on_the_future_regulation_of_medical_devices_in_the_United_Kingdom.pdf\"><em>Government response to consultation on the future regulation of medical devices in the United Kingdom<\/em><\/a> updated last June 26, MHRA in fact expresses the possibility of allowing devices already CE-marked to remain on the UK market after June 30, 2023. Such an extension would depend on the expiration of the certificate or a defined term, namely 3 years (for Medical Devices) and 5 years (for IVDs).<\/p>\n<p>In detail, the extension would be as follows:<\/p>\n<ul>\n<li>CE marked devices benefitting from a Period of Grace in accordance with MDD, AIMDD and IVDD: can be placed on the market for 3-5 years from 01\/07\/2023;<\/li>\n<li>CE marked devices in accordance with MDR and IVDR: can be placed on the market for 3-5 years or until the expiration of the EU certificate, whichever is earlier.<\/li>\n<\/ul>\n<p>However, it would be possible to take advantage of this extension upon the occurrence of certain conditions during the transitional period, in particular:<\/p>\n<ul>\n<li>the absence of significant changes involving the design or intended use of the device;<\/li>\n<li>full compliance with the post-market surveillance requirements defined by UK regulations;<\/li>\n<li>that certificate and declaration of conformity have been issued prior to 30\/06\/2023;<\/li>\n<li>that the devices were placed on the market in the territory before 30\/06\/2023 in compliance with UK legislative and regulatory requirements, particularly with regard to registration with MHRA.<\/li>\n<\/ul>\n<p>No problem of free circulation in the UK territory, on the other hand, for devices already with UKCA marking as of July 1, 2023.<\/p>\n<p>If ratified, this choice would be of <strong>clear benefit to all non-UK manufacturers<\/strong> of medical devices and IVDs, ensuring them a useful extension of time to obtain a UKCA certificate from designated Notified Bodies who today are still insufficient in number to be able to cope with market and health needs.<\/p>\n<p>&gt;&gt;&gt; Rely on <strong>Thema<\/strong> for the <a href=\"https:\/\/www.thema-med.com\/en\/services\/local-representative-and-license-holder\/uk-responsible-person-service\/\">UKRP service<\/a> needed to meet regulatory requirements useful for marketing devices in the UK.<\/p>\n<p>Want to learn more? Go to the <a href=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/07\/UKRP_EN.pdf\">UKRP Service Sheet<\/a><\/p>\n<p>&gt;&gt;&gt; If you need more information for technical-regulatory or strategic support from our UK experts, <a href=\"mailto:sales@thema-med.com\">Contact our Customer Service.<\/a><\/p>\n<p>&gt;&gt;&gt; Stay up-to-date on pre-market requirements for device commercialization in the UK and <strong><a href=\"https:\/\/www.thema-med.com\/en\/library\/brexit-news\/\">subscribe to Brexit News<\/a><\/strong>.<\/p>\n<p>Source: <a href=\"https:\/\/assets.publishing.service.gov.uk\/government\/uploads\/system\/uploads\/attachment_data\/file\/1085333\/Government_response_to_consultation_on_the_future_regulation_of_medical_devices_in_the_United_Kingdom.pdf\"><em>Government response to consultation on the future regulation of medical devices in the United Kingdom<\/em><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>In order to avoid a blockage of healthcare supplies in the territory, MHRA (Medicines and Healthcare products Regulatory Agency) is considering  [&#8230;]<\/p>\n","protected":false},"author":114,"featured_media":22869,"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-22888","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 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>UK: possible extension of CE marking validity - Thema Med<\/title>\n<meta name=\"description\" content=\"In order to avoid a blockage of healthcare supplies in the territory, MHRA (Medicines and Healthcare products Regulatory 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