UKCA marking for medical devices in 2026: what is actually required

UKCA marking for medical devices is one route to the Great Britain market, and in 2026 it is not the only one. CE marked devices are still accepted in Great Britain until 30 June 2028 or 30 June 2030, depending on the legislation they were certified under, so for most manufacturers the live question is when UKCA becomes necessary for their device and whether to start now.

An earlier version of this guide described UKCA as required for the Great Britain market and left Northern Ireland to one side. This version replaces it. It covers what UKCA marking is, the CE acceptance dates, what Northern Ireland needs, what is proposed for the mark itself, the labelling point that is easy to miss, and what to decide this year.

What is UKCA marking?

UKCA stands for UK Conformity Assessed. It is the Great Britain conformity mark under the UK Medical Devices Regulations 2002, and Great Britain means England, Scotland and Wales. Where a conformity assessment body is needed, that is a UK Approved Body rather than an EU Notified Body.

The rules behind it are not the EU rules with a new logo. General medical devices in Great Britain are still classified under Annex IX of Directive 93/42/EEC, as modified by the UK regulations, not under Annex VIII of the EU Medical Device Regulation (EU MDR). A device classified for the EU can land in a different class for Great Britain, so the class is the first thing to settle. Our guide to medical device classification shows where the systems differ.

A UKCA mark does not replace the other Great Britain duties. The device still has to be registered with the Medicines and Healthcare products Regulatory Agency (MHRA), a manufacturer based outside the UK still needs a UK Responsible Person, and the post market surveillance rules in force since 16 June 2025 still apply.

Is UKCA marking mandatory for medical devices in 2026?

No. Under current law, CE marked devices can still be placed on the Great Britain market within these dates. The legislation abbreviations are the Medical Devices Directive (MDD), the Active Implantable Medical Devices Directive (AIMDD), the In Vitro Diagnostic Medical Devices Directive (IVDD) and the EU In Vitro Diagnostic Regulation (EU IVDR).

CE marked under	Accepted in Great Britain until
MDD or AIMDD, certified by a Notified Body	The sooner of certificate expiry or 30 June 2028
IVDD	The sooner of certificate expiry or 30 June 2030
EU MDR, including custom made devices	30 June 2030
EU IVDR	30 June 2030

The MHRA adds one exception to the directive dates: they do not apply to Class I devices and general IVDs where neither the directive nor the EU MDR or IVDR requires a Notified Body. For those self declared devices the question is whether they meet the EU MDR or IVDR, so check which group your device falls into before relying on 2028.

Read the words “the sooner of”. An MDD certificate that expires in 2027 does not get you to 2028. The earlier date wins.

Once the date for your certificate has passed, current law leaves two options for Great Britain: a CE certificate that is still inside its own date, or a UKCA mark. After 30 June 2030, only UKCA remains. That is the honest position today. It could change, and the next section explains why you should not plan on it.

Will CE marks be accepted in Great Britain indefinitely?

It has been proposed. It is not the law. The government ran a targeted consultation from 16 February to 10 April 2026 on three ideas: extending the MDD transitional arrangements to match the EU MDR transition timelines, recognising EU MDR and EU IVDR compliant devices indefinitely, and an international reliance route for devices classed higher in Great Britain than in the EU. No outcome has been published. The consultation page says the government is analysing the feedback.

There is a second signal worth knowing. In its July 2025 consultation response, the government said it would implement international reliance Routes 1, 3 and 4, but deferred Route 2, the route for CE marked devices. Reliance for devices approved in Australia, Canada and the USA is in the draft Medical Devices (Amendment) Regulations 2026, which were published on the World Trade Organization notification portal on 8 May 2026 and had not been laid before Parliament as of 25 September 2026.

So the 2028 and 2030 dates stand. A plan that only works if indefinite recognition arrives in time is a bet. Our guide to the UK Medical Devices Regulations 2002 sets out what is law now and what is still draft.

What do you need for Northern Ireland?

Northern Ireland follows the EU rules. The EU MDR has applied there since 26 May 2021 and the EU IVDR since 26 May 2022. CE marking is required. UKCA on its own does not get a device onto the Northern Ireland market.

Three further points:

• Where a UK notified body carries out the conformity assessment, the device needs a combined CE and UK(NI) mark.
• A Great Britain manufacturer supplying Northern Ireland must designate a sole authorised representative based in the EU or Northern Ireland.
• Since 28 May 2026, devices placed on the Northern Ireland market, other than custom made devices, are registered on EUDAMED, the European database on medical devices. Custom made devices are still registered with the MHRA.

If you sell across the whole UK, you are working to two systems at once. Map both before you choose a mark.

Is UKCA being scrapped?

No. The MHRA says the UKCA regime will remain in place in Great Britain while any future model is developed.

What is proposed is narrower. In its 22 July 2025 response, the government said it will remove the requirement to affix the UKCA mark, on condition that the manufacturer assigns a Unique Device Identification (UDI) and the UDI is searchable in a public database. The planned UDI transitional periods are three years for general devices and five years for in vitro diagnostics (IVDs). The draft 2026 amendments make UDI compulsory. None of that is law yet, and the mark still has to be affixed on devices placed through the UKCA route today.

The Health Bill is the other change people misread. On 1 September 2026 the government tabled amendments that include powers to support a future MHRA medical device licensing regime, under which devices placed on the market through a domestic route could in future need an MHRA licence rather than relying on third party conformity assessment. The government’s fact sheet says the bill does not itself establish a licensing regime. These are enabling powers, and nothing about your UKCA obligations changes because of them today.

What has to appear on the label?

Where the UKCA mark is affixed, the UK Responsible Person’s name and address must appear on the labelling, the outer packaging or the instructions for use. It is easy to miss on artwork prepared for the EU, which names an authorised representative and no UK Responsible Person.

The appointment itself sits in regulation 7A of the UK regulations. A manufacturer based outside the UK must appoint a sole UK Responsible Person, who gives the Secretary of State written evidence of its authority to act. Our complete guide to the UK Responsible Person covers the duties that come with it.

What should manufacturers decide now?

The right answer depends on the certificate you hold today.

• You hold an MDD or AIMDD certificate. Your Great Britain date is 30 June 2028 or your certificate expiry, whichever comes first. Decide now whether you are moving to the EU MDR, which buys you to 30 June 2030 in Great Britain, or to UKCA, and budget the time. Our guide to the MDD to MDR transition for legacy devices covers the EU side.
• You hold an EU MDR or EU IVDR certificate. You have until 30 June 2030 under current law. Use the time to see whether the consultation outcome or the reliance routes change your route, but keep UKCA in the plan until they do.
• You are launching a new device in Great Britain. Choose the route on the dates in law. A new CE certificate under the EU MDR is accepted to 30 June 2030. After that, current law points to UKCA.
• You also sell in Northern Ireland. You need CE marking there whatever you do in Great Britain.

Whichever route you take, three things do not wait. Register the device with the MHRA. Get the UK Responsible Person on the label. And run post market surveillance to the Great Britain rules, which apply to CE and UKCA marked devices alike. Our MHRA registration guide covers the first of those.

Where Worldwide Device Solutions fits

The choice between CE and UKCA always starts with two facts: the certificate you hold and the class of the device in each market. Our CE and UKCA marking service takes a device from classification to a mark that holds up in both markets, backed by 500+ CE technical files built and approved and 600+ companies to first time approval. We also act as UK Responsible Person from Newcastle upon Tyne and EU Authorised Representative from Cork, on one contract.

If you are not sure which date applies to your device or which mark to plan for, book a free consultation and Paul will give you a straight answer. For a full picture of the gaps, start with the fixed fee Gap Assessment.