{"id":29645,"date":"2026-10-29T11:14:27","date_gmt":"2026-10-29T11:14:27","guid":{"rendered":"https:\/\/quickbirdmedical.com\/?post_type=news&#038;p=29645"},"modified":"2026-10-29T11:14:55","modified_gmt":"2026-10-29T11:14:55","slug":"ce-marking-uk-mdr-ivdr-recognition","status":"publish","type":"news","link":"https:\/\/quickbirdmedical.com\/en\/news\/ce-marking-uk-mdr-ivdr-recognition\/","title":{"rendered":"Great Britain Plans Indefinite Recognition of CE Marking"},"content":{"rendered":"<p>On October 21, 2026, the UK government published its response to a consultation by the Medicines and Healthcare products Regulatory Agency (MHRA): Medical devices and in vitro diagnostics with CE marking under the MDR or IVDR are to be <strong>recognized indefinitely<\/strong> in Great Britain. So far, this is only planned until June 30, 2030.<\/p>\n<p><strong>The key points:<\/strong><\/p>\n<ul>\n<li>No additional <strong>national assessment<\/strong> for CE marked devices under the MDR and IVDR, regardless of risk class<\/li>\n<li>MDD devices: The British transition periods are to be aligned with the EU (December 31, 2027 or December 31, 2028, depending on the class)<\/li>\n<li>A <strong>UK Responsible Person<\/strong> and <strong>MHRA registration<\/strong> remain mandatory<\/li>\n<li>UKCA marking remains available as a national route<\/li>\n<\/ul>\n<p>The legislative changes are to be made before <strong>June 30, 2028<\/strong>. Parliament still has to approve them. The decision is based on a consultation with 1,056 responses.<\/p>\n<p>For manufacturers of software as a medical device, CE marking under the MDR is thus to remain the route to the UK market in Great Britain in the long term. Additional UKCA marking would not be required.<\/p>\n<p><a href=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/\/2026\/10\/ce-marking-uk-en_1.svg\"><img decoding=\"async\" class=\"alignnone wp-image-29658 size-large\" src=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/\/2026\/10\/ce-marking-uk-en_1.svg\" alt=\"CE marking UK: so far, recognition under MDR and IVDR until June 30, 2030, planned indefinitely without additional UKCA assessment\" width=\"1024\" height=\"468\" \/><\/a><\/p>\n<p>Sources:<\/p>\n<ul>\n<li>GOV.UK: <a href=\"https:\/\/www.gov.uk\/government\/news\/government-confirms-indefinite-recognition-of-ce-marked-medical-devices?utm_source=website-quickbirdmedical&amp;utm_medium=website&amp;utm_campaign=news\">Government confirms indefinite recognition of CE marked medical devices<\/a><\/li>\n<li>MHRA: <a href=\"https:\/\/assets.publishing.service.gov.uk\/media\/6ad76f8be9713babfbe3f755\/Government_response_to_the_targeted_consultation_on_indefinite_recognition_of_CE_marked_medical_devices.pdf?utm_source=website-quickbirdmedical&amp;utm_medium=website&amp;utm_campaign=news\">Government response to the targeted consultation (PDF)<\/a><\/li>\n<\/ul>\n","protected":false},"featured_media":0,"template":"","categories":[],"tags":[],"display":[54],"class_list":["post-29645","news","type-news","status-publish","hentry","display-display-on-news-page"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>CE Marking UK: Indefinite Recognition Planned<\/title>\n<meta name=\"description\" content=\"CE marking UK: The government plans to recognize medical devices under MDR and IVDR indefinitely. 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