{"id":28476,"date":"2023-07-07T10:59:51","date_gmt":"2023-07-07T08:59:51","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=28476"},"modified":"2023-08-04T12:12:18","modified_gmt":"2023-08-04T10:12:18","slug":"uk-mhra-extends-ce-marking-validity","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2023\/07\/07\/uk-mhra-extends-ce-marking-validity\/","title":{"rendered":"UK: MHRA extends CE marking validity"},"content":{"rendered":"<h2>Medicines and Healthcare products Regulatory Agency (MHRA) extended the timeframe for the acceptance of CE-marked medical devices and in vitro diagnostic (IVD) devices within the UK to ensure the continued safe supply of devices in the country.<\/h2>\n<p>On 14 June, MHRA published <a href=\"https:\/\/www.legislation.gov.uk\/uksi\/2023\/627\/pdfs\/uksi_20230627_en.pdf\"><strong><em>Statutory Instrument 2023 No. 627 &#8216;Medical Devices (Amendment) (Great Britain) Regulations 2023<\/em><\/strong><\/a> extending the period for placing CE-marked medical devices and IVDs on the market.<\/p>\n<p>Specifically, CE-marked medical devices may continue to be marketed according to different deadlines, namely:<\/p>\n<ul>\n<li>class III and class IIb implantable devices until <strong>31\/12\/2027<\/strong>;<\/li>\n<li>class IIb, class IIa, class Is, Im and Ir devices until <strong>30\/06\/2028<\/strong>;<\/li>\n<li>self-certified MDD class I devices, reclassified by the MDR, until <strong>30\/06\/2028<\/strong>.<\/li>\n<\/ul>\n<p>In the case of CE-marked IVD devices, marketing may continue as follows:<\/p>\n<ul>\n<li>self-declaration and class D devices until <strong>26\/05\/2025<\/strong>;<\/li>\n<li>Class C devices until <strong>26\/05\/2026<\/strong>;<\/li>\n<li>Class B and Class A sterile devices until <strong>26\/05\/2027<\/strong>.<\/li>\n<\/ul>\n<p>As mentioned, therefore, in order to ensure the presence of devices within the country&#8217;s healthcare facilities, the UK Regulatory Authority has extended the timeframe for the acceptance of medical devices and IVDs but also said it would review and update its regulations as of <strong>01\/07\/2025<\/strong>. The latter is not likely to deviate significantly from European regulation in that the conformity assessment processes and standards to be used to demonstrate compliance under the <strong>UKCA mark<\/strong> will be almost the same as those applicable to the CE mark.<\/p>\n<p>&gt;&gt;&gt; If you want to market medical devices and IVDs in the UK, Thema can assist you with the <a href=\"https:\/\/www.thema-med.com\/en\/services\/strategic-regulatory-consulting-2\/\"><strong>Strategic Regulatory Consulting Service<\/strong><\/a>, can be your <a href=\"https:\/\/www.thema-med.com\/en\/services\/local-representative-and-license-holder\/uk-responsible-person-service\/\"><strong>UK Responsible Person (UKRP)<\/strong><\/a> and can support you in <strong>registering products<\/strong> with MHRA.<\/p>\n<p><strong>Source<\/strong><\/p>\n<p><a href=\"https:\/\/www.legislation.gov.uk\/uksi\/2023\/627\/pdfs\/uksi_20230627_en.pdf\">The Medical Devices (Amendment) (Great Britain) Regulations 2023<\/a><\/p>\n<p><a href=\"https:\/\/www.gov.uk\/government\/publications\/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period#full-publication-update-history\">Implementation of medical devices future regime<\/a><\/p>\n<p><a href=\"https:\/\/assets.publishing.service.gov.uk\/government\/uploads\/system\/uploads\/attachment_data\/file\/1166483\/Infographic_-_Devices_transition_timeline.pdf\">Timelines for placing CE marked IVDs on the Great Britain market<\/a><\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Medicines and Healthcare products Regulatory Agency (MHRA) extended the timeframe for the acceptance of CE-marked medical devices and in vitro diagnostic  [&#8230;]<\/p>\n","protected":false},"author":114,"featured_media":28501,"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-28476","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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