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# UKCA markings dropped and CE marked devices to be indefinitely recognised
- URL: https://med-techinsights.com/ukca-markings-dropped-and-ce-marked-devices-to-be-indefinitely-recognised/
- Published: 2025-07-23T11:10:08.000Z
- Updated: 2026-10-23T02:45:28.000Z
- Description: Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, an advisor to MedTech suppliers, chair of the Urology Trade Association, and governor of the Anscombe Bioethics Centre, reports on the MHRA’s response to its recent public co
- Author: Oliver Johnson
- Tags: Insights, Policy & Regulation

###### [*Chris Whitehouse*](https://med-techinsights.com/tag/chris-whitehouse/)*, a political consultant and expert on medical technology policy and regulation at* [*Whitehouse Communications*](http://www.whitehousecomms.com/?ref=med-techinsights.com)*, an advisor to MedTech suppliers, chair of the* [*Urology Trade Association,*](https://urologytradeassociation.com/?ref=med-techinsights.com) *and governor of the* [*Anscombe Bioethics Centre*](https://www.bioethics.org.uk/?ref=med-techinsights.com)*, reports on the MHRA’s response to its recent public consultation on the modernisation of MedTech regulation.*

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Requirements for MedTech devices physically to display the UKCA (UK Conformity Assessed) marking, which confirms a device’s compliance with regulatory standards is set to be dropped, the [**MHRA**](https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency?ref=med-techinsights.com) (The Medicines and Healthcare products Regulatory Agency) [has announced](https://www.gov.uk/government/news/mhra-announces-proposals-to-improve-access-to-worlds-best-medical-devices-for-patients-and-to-boost-economic-growth-in-britains-med-tech-sector?utm%5Fmedium=email&utm%5Fcampaign=govuk-notifications-topic&utm%5Fsource=12d23b4f-5280-45a2-89fd-ffe871e21c16&utm%5Fcontent=immediately).

The move, made [in response](https://www.gov.uk/government/consultations/consultation-on-medical-devices-regulations-routes-to-market-and-in-vitro-diagnostic-devices/outcome/response-to-assimilated-eu-law-consultation-proposal?ref=med-techinsights.com) to a recent consultation on the future of MedTech regulation, including AI devices, is set to happen once Unique Device Identification (UDI) is in place, requiring medical devices to be individually identifiable. This aims to reduce burdens on manufacturers while improving traceability and post-market surveillance.

Another move confirmed in the announcement is that international reliance routes will allow certain devices that have approvals or certifications from trusted regulators in Australia (TGA), Canada (Health Canada), and the United States (FDA) to follow a streamlined pathway to the British market. This includes specific software and implantable devices that meet British equivalence criteria.

The MHRA also confirmed that it will consult later this year on proposals indefinitely to recognise [CE (Conformité Européene) marked medical devices](https://www.gov.uk/guidance/ce-marking?ref=med-techinsights.com), which continue to be recognised in Great Britain under existing transitional arrangements until 30 June 2028 or 2030 (depending on the device classification and legislation complied with). The CE mark confirms that a device meets the rules of the European Union

[Class B In Vitro Diagnostic Devices](https://www.bsigroup.com/globalassets/meddev/localfiles/fr-fr/whitepapers/md-classification%5Fissues%5Ffor%5Fivd.pdf?ref=med-techinsights.com) will be subject to a more risk proportionate approach, claims the MHRA, requiring manufacturers to self-declare conformity with the [Medical Devices Regulations 2002](https://www.legislation.gov.uk/uksi/2002/618/contents?ref=med-techinsights.com) and hold [ISO 13485](https://www.iso.org/iso-13485-medical-devices.html?ref=med-techinsights.com) quality management system certification before placing products on the GB market.

The response to a fourth proposal, to extend four pieces of assimilated EU law, [was published in February 2025](https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.gov.uk%2Fgovernment%2Fconsultations%2Fconsultation-on-medical-devices-regulations-routes-to-market-and-in-vitro-diagnostic-devices%2Foutcome%2Fresponse-to-assimilated-eu-law-consultation-proposal&data=05%7C02%7CJamie.McDowell%40mhra.gov.uk%7C3643e8d8cae448c4ea7108ddc62c2e04%7Ce527ea5c62584cd2a27f8bd237ec4c26%7C0%7C0%7C638884615237746855%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=iy4GLH8uT3aSFs%2FF1PbXxnNM%2B8iD4J%2B%2FHbmfrH89NnM%3D&reserved=0&ref=med-techinsights.com) and has subsequently been actioned.

Commenting on the announcements, Lawrence Tallon, MHRA Chief Executive Officer, said: “Our focus is on ensuring that patients benefit from the earliest possible access to safe and effective medical technologies that meet their needs and deliver significant clinical benefit.

“By reducing regulatory duplication, improving traceability and aligning with international best practice, we are delivering on the Government’s promise to make this the best place in the world to market medical devices and a global leader in life sciences”.

The announcement was flagged in the recently published [Life Sciences Sector Strategy,](https://med-techinsights.com/2025/07/16/government-commits-to-life-sciences-for-economic-growth/) as one of a series of coming steps to promote MedTech innovation and adoption, to boost patient outcomes and deliver economic growth.

*The Author used AI in preparing this article, comments upon or questions about which can be addressed to* [*chris.whitehouse@whitehousecomms.com*](mailto:chris.whitehouse@whitehousecomms.com).