Medical Devices
UKCA stands for UK Conformity Assessed. It is the product marking that shows goods placed on the market in Great Britain meet the UK's product safety rules, and it took over from the CE mark after Brexit. This guide explains which products need it, how CE marking is treated in Great Britain today, how the mark is applied, and what is different for medical devices, where the deadlines still matter.
Written for product and regulatory teams. Dates checked against GOV.UK guidance in October 2026.
The UKCA (UK Conformity Assessed) marking was introduced on 1 January 2021, when the UK left the EU's single market. It is the marking used for goods placed on the market in Great Britain (England, Scotland and Wales) that previously needed the CE marking, and it signals that the manufacturer has checked the product against the relevant UK regulation and takes responsibility for its conformity.
Like the CE mark, UKCA is not a quality mark and no authority issues it. The manufacturer applies it after completing the conformity assessment the regulation demands: sometimes a self-declaration against designated standards, sometimes third-party assessment by a UK Approved Body. The mark is backed by technical documentation and a signed UK Declaration of Conformity that must be kept for ten years.
UKCA is a Great Britain mark only. It is not recognised in the EU, and it cannot be used on its own for goods placed on the market in Northern Ireland, which continues to follow EU rules under the Windsor Framework.
The UK Government's position on CE marking changed in 2024, and that is the part most guides online have not caught up with. Under The Product Safety and Metrology (Amendment) Regulations 2024, CE marking continues to be recognised in Great Britain for most product groups with no end date, so UKCA is now a choice rather than an obligation for many manufacturers. Medical devices are the main exception, covered below.
UKCA applies to the product groups that used CE marking before 2021: machinery, electrical and electronic equipment, toys, personal protective equipment, pressure equipment, gas appliances, radio equipment, measuring instruments, recreational craft, lifts and equipment for explosive atmospheres, around twenty regimes in all, plus aerosols that previously used the reversed epsilon mark.
Cosmetics, food and food supplements, medicines, chemicals under UK REACH and most consumer goods under the General Product Safety Regulations do not carry UKCA or CE marking. They have their own regimes: for cosmetics, a UK Responsible Person, a Product Information File and SCPN notification; for food supplements, a UK Food Business Operator and labelling rules.
Medical devices and in vitro diagnostics are UKCA regimes under the UK Medical Devices Regulations 2002, but with their own conformity assessment, their own UK Approved Bodies and their own transition dates. Construction products, rail, marine equipment, cableways, transportable pressure equipment and uncrewed aircraft also have sector-specific rules.
If you are unsure which regime your product falls under, the regulation that applied to it before 2021 is the best guide: a CE-marked product is almost always a UKCA regime product, and a product that never carried CE almost never is.
Three positions apply at once, depending on what you sell and where you sell it.
For the product groups covered by the 2024 regulations, a CE-marked product that meets EU requirements can be placed on the Great Britain market without a UKCA mark, and there is no end date. You may use UKCA, CE or both. The UK keeps the power to diverge in future, which is why the position is worth re-checking before each major launch.
CE-marked medical devices can be placed on the Great Britain market only until set dates: 30 June 2028 for devices certified under the old EU directives (MDD and AIMDD), and 30 June 2030 for IVDs under the IVDD and for all devices and IVDs under the EU MDR and IVDR. After those dates, UKCA marking is required.
Goods placed on the market in Northern Ireland follow EU rules and carry the CE mark. If a UK Approved Body carried out the mandatory third-party assessment, the UKNI marking is applied alongside CE. UKCA on its own is not valid in Northern Ireland, and CE plus UKNI is not valid in the EU.
Qualifying Northern Ireland goods can move to Great Britain on their CE or CE plus UKNI marking without further assessment. GOV.UK guidance is updated regularly; the version we checked for this page is dated 21 August 2026.
The route mirrors CE marking, and if you already hold a CE technical file most of the work is done. The steps are:
Identify every UK regulation that applies to the product, and the designated standards that give a presumption of conformity
Check whether the regulation allows self-declaration for your product, or requires assessment by a UK Approved Body
Carry out the conformity assessment, including any testing, and compile the technical documentation
Draw up and sign the UK Declaration of Conformity, listing the regulations and standards relied on
Apply the UKCA mark, legibly and at least 5 mm high, together with the Approved Body number where one was involved
Keep the technical file and declaration for ten years, and make them available to market surveillance authorities on request
Until 11pm on 31 December 2027, the UKCA mark may be placed on a label affixed to the product or on an accompanying document rather than on the product itself, for most regimes. You can also choose to put it on the product now. Medical devices, construction products and a few other sectors follow their own placement rules.
Medical devices placed on the Great Britain market must be UKCA marked under the UK Medical Devices Regulations 2002 unless they are still within the CE acceptance periods above. Non-sterile, non-measuring Class I devices and general IVDs can be self-certified by the manufacturer; every other class needs a UK Approved Body to assess the device and the quality system, which in practice means an ISO 13485 system.
All devices, including Class I, must be registered with the MHRA before they are placed on the market. Manufacturers based outside the UK cannot register directly: they must appoint a UK Responsible Person, who registers the devices, holds the technical documentation for the regulator and handles incident reporting.
The practical question for most device makers is sequencing: whether to run UKCA alongside an EU MDR CE certificate now, or to rely on CE recognition until 2028 or 2030 and plan the UKCA assessment into the next certification cycle. Approved Body capacity is limited, so the second route needs a start date well before the deadline.
Manufacturers outside the UK must appoint a UK Responsible Person before registering devices with the MHRA. We hold the role for device makers of every class.
A product may carry both marks, and many do, so that one label serves Great Britain and the EU. The two marks must each be backed by their own declaration of conformity and, where third-party assessment is required, by the right body: an EU Notified Body for CE and a UK Approved Body for UKCA. One assessment does not count for both, even when the standards are identical.
Where CE is recognised indefinitely, dual marking is optional and mainly a matter of future-proofing. For medical devices it is the normal end state, because CE acceptance in Great Britain ends and UKCA is not accepted in the EU.
No. This is one of the most common questions we are asked, usually by brands that have been told by a marketplace or a printer that everything sold in the UK needs a conformity mark. Cosmetics are regulated by the UK Cosmetics Regulation and carry no UKCA or CE mark. What they need is a UK Responsible Person named on the label, a Product Information File with a signed safety report and an SCPN notification before launch.
Food supplements are foods, regulated under food law. They need a UK Food Business Operator named on the label and compliant labelling and claims, not a conformity mark. Putting UKCA on a cosmetic or a supplement is a labelling error, not a safeguard.
For most product groups, no. Since the 2024 regulations, CE marking is recognised in Great Britain indefinitely, so manufacturers may use UKCA, CE or both. For medical devices UKCA becomes mandatory as the CE acceptance dates expire: 30 June 2028 for devices under the old directives and 30 June 2030 for the rest.
They do the same job for different markets. CE shows conformity with EU law and is recognised across the EU, Northern Ireland and, for most goods, Great Britain. UKCA shows conformity with UK law and is valid only in Great Britain. The technical requirements are closely aligned today, but the declarations, the designated standards and the assessment bodies are separate.
It depends on the regulation and the product. Many regulations allow the manufacturer to self-declare against designated standards. Higher-risk products, including most medical devices above Class I, need a UK Approved Body. The regulation that applies to your product states which route is open to you.
No. Cosmetics fall under the UK Cosmetics Regulation and need a UK Responsible Person, a Product Information File and an SCPN notification. Food supplements fall under food law and need a UK Food Business Operator. Neither carries UKCA or CE marking.
No. Northern Ireland follows EU rules, so goods there carry the CE mark. If a UK Approved Body did the mandatory assessment, UKNI is applied alongside CE. UKCA alone is not valid in Northern Ireland, and CE plus UKNI is not valid in the EU.
For medical devices, yes if the manufacturer is based outside the UK: the UK Responsible Person registers the devices with the MHRA and holds the documentation. For most other UKCA regimes the equivalent role is the UK importer or an authorised representative, and the duties are lighter. Cosmetics have their own UK Responsible Person requirement, unrelated to UKCA.
We are not an Approved Body and we do not certify products. We help medical device manufacturers plan the UKCA route, build and audit ISO 13485 quality systems, prepare technical documentation, register with the MHRA and act as UK Responsible Person. If your question is about a cosmetic or a food supplement, we handle those regimes too, and the first thing we will tell you is that UKCA is not the issue.
