UKCA Marking and MHRA

Classification and legal basis

In Great Britain (England, Wales, and Scotland), medical devices are regulated under the Medical Devices Regulations 2002 (Statutory Instrument 2002 No. 618, as amended, UK MDR 2002 for short; a statutory instrument is a form of secondary legislation in the UK). The competent authority is the Medicines and Healthcare products Regulatory Agency (MHRA). Among other things, the regulations are divided into Part II for general medical devices, Part III for active implantable devices, Part IV for in vitro diagnostic devices, and Part V for Approved Bodies, conformity assessment bodies, and the marking of devices. As of October 8, 2026, the version on legislation.gov.uk reflected all known amendments.

Northern Ireland follows a different regime that is oriented toward the European MDR (see below). This term covers market access in Great Britain. The European approach with CE marking is covered in the term CE Marking and Technical Documentation.

UKCA marking and conformity assessment

The UKCA marking (UK Conformity Assessed) is a British product mark for the market in Great Britain. It indicates that a device meets the requirements of the UK MDR 2002. It is not recognized in the EU, in the European Economic Area, or in Northern Ireland. Before affixing it, the manufacturer signs a declaration of conformity. If an Approved Body was involved, its identification number appears below the UKCA marking.

Which route applies depends on the risk class. The MHRA describes it as follows:

Class I devices that are non-sterile and have no measuring function, as well as general in vitro diagnostic devices, may carry the UKCA marking by self-certification. Approved Bodies are designated by the MHRA and carry out assessments under Parts II, III, and IV of the UK MDR 2002. They may not assess for the CE marking. The official register of British conformity assessment bodies is the UKMCAB database. According to the MHRA, British bodies that previously operated as notified bodies under EU law automatically became Approved Bodies. The counterpart under EU law is the Notified Body.

CE marking in Great Britain and transition periods (as of October 2026)

In addition to UKCA, CE-marked devices continue to be accepted on the British market for a limited period, at the latest until June 30, 2030, depending on the type of device and the underlying EU law. The legal basis is amendments to the UK MDR 2002 made by the Medical Devices (Amendment) (Great Britain) Regulations 2023 (SI 2023 No. 627). On gov.uk, the MHRA states the following deadlines:

According to the MHRA, custom-made devices under the directives are no longer permitted, and expired certificates may not be relied on unless the EU otherwise treats them as valid. The mandatory third-party assessment for the CE marking must be carried out by an EU notified body.

From February 16 to April 10, 2026, the MHRA consulted on whether CE-marked devices under the MDR and IVDR should be recognized indefinitely. Further proposals concerned an extension of the MDD transition period and a route via international approvals for devices that are classified higher in Great Britain than in the EU. No outcome had been published on the gov.uk pages reviewed as of October 10, 2026. The MHRA writes that the existing transitional arrangements remain in force until then. Anyone who needs deadlines for a market access decision should check the gov.uk page again at the time of the decision.

Registration with the MHRA and the UK Responsible Person

All devices, including in vitro diagnostic devices, custom-made devices, and system or procedure packs, must be registered with the MHRA before being placed on the market in Great Britain. The MHRA accepts direct registrations only from manufacturers based in the United Kingdom. Manufacturers without a British base appoint a UK Responsible Person, who registers the device and acts on behalf of the manufacturer. Importers and distributors do not need a UK Responsible Person of their own.

According to the MHRA, the tasks of the UK Responsible Person include, among others:

• ensuring that the declaration of conformity and the technical documentation have been drawn up,
• keeping the documentation available for MHRA inspections and presenting it on request,
• cooperating with the MHRA on corrective actions,
• informing the manufacturer without delay about complaints and incident reports.

The name and address of the UK Responsible Person belong on the label, the outer packaging, or the instructions for use, wherever the UKCA marking is affixed. The requirements for monitoring after placing on the market are set out in Part 4A of the UK MDR 2002 (Post-market surveillance).

Northern Ireland

In Northern Ireland, the EU MDR has applied since May 26, 2021, and the EU IVDR since May 26, 2022. The CE marking is required there. If a device was assessed by a British notified body, the UKNI indication is also required, which applies only in Northern Ireland and is not accepted in the EU. Devices with the UKCA marking may be placed on the market in Northern Ireland only with an additional CE marking. Manufacturers based in Great Britain appoint an authorized representative based in the EU or in Northern Ireland for Northern Ireland. The MHRA remains the competent authority there for monitoring after placing on the market.

Standards and human factors

The MHRA sources reviewed do not describe a separate usability process. Regulation 3A defines “designated standards,” that is, technical specifications whose application is not mandatory and which the competent minister designates by publishing a reference. Notice 0129/26 of the Department of Health and Social Care of January 17, 2026 lists in the valid list, among others: EN 62366-1:2015 with amendment A1:2020 (usability engineering), EN ISO 13485:2016 with corrigendum AC:2018 and amendment A11:2021, and EN ISO 14971:2019 with amendment A11:2021. A note accompanies the usability standard: it does not necessarily cover the requirements that S.I. 2008/2936 introduced into the regulations, and manufacturers should check whether all relevant essential requirements are adequately covered. The standard itself is explained in a separate term.

This distinguishes the British situation from the European one: IEC 62366-1 is not listed in Implementing Decision (EU) 2021/1182 on harmonized standards, but it is listed in Great Britain as a designated standard. What legal effect the designation has in detail was not examined here. The MHRA guidance page on the UKCA marking does not mention usability and human factors explicitly, but cites ISO 13485 and ISO 14971 as examples of designated standards. For human factors evidence, this means by inference: manufacturers who conduct their usability engineering according to the standard and document it in the usability engineering file can rely on a standard designated in Great Britain. This is an inference from the list and not a statement by the MHRA.

Distinction from related terms

• In Great Britain, the Approved Body replaces the EU notified body for UKCA, but does not assess for the CE marking.
• The UK Responsible Person is an actor under British law. It resembles the authorized representative under EU law but is not equivalent to it.
• The UKCA marking replaces neither the CE marking for the EU market nor the UKNI indication for Northern Ireland.
• The quality management standard ISO 13485 is listed in Great Britain as a designated standard and is explained in a separate term.

Frequently asked questions (FAQ)

Sources

• Regulation (EU) 2017/745 on medical devices (MDR)
• IEC 62366-1:2015+AMD1:2020, Medical devices, Part 1: Application of usability engineering to medical devices
• ISO 13485:2016, Medical devices, Quality management systems, Requirements for regulatory purposes
• ISO 14971:2019, Medical devices, Application of risk management to medical devices
• Commission Implementing Decision (EU) 2021/1182 on harmonised standards for medical devices, consolidated version of 06/17/2026
• The Medical Devices Regulations 2002 (SI 2002/618), legislation.gov.uk
• The Medical Devices (Amendment) (Great Britain) Regulations 2023 (SI 2023/627)
• GOV.UK (MHRA): Regulating medical devices in the UK
• GOV.UK (MHRA): Medical devices, conformity assessment and the UKCA mark
• GOV.UK (MHRA): Timelines for acceptance of CE marked medical devices in Great Britain
• GOV.UK (MHRA): Targeted consultation on the indefinite recognition of CE marked devices
• Department of Health and Social Care: Notice of publication 0129/26, references to standards for medical devices, January 17, 2026

Related terms

• MDR (Medical Device Regulation)
• IEC 62366-1
• Usability engineering file
• Risk management (ISO 14971)
• Post-market surveillance
• Usability engineering process

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