You have CE and FDA clearance, but UKCA is blocking your path to market

Post-Brexit divergence means CE marking no longer guarantees UK market access. UKCA requirements, MHRA registration, and shifting transition timelines are a distinct regulatory pathway, and a failed submission is expensive to put right.

steps: 7; steps
to start: 1 to 3 days; to start

The short answer

For most devices, you do not need UKCA marking to sell in Great Britain. On 21 October 2026 the government confirmed that CE-marked devices will be recognised in Great Britain on a long-term basis, although the regulations have not yet been made. Until they are, the current deadlines apply: 30 June 2028 for devices certified under the old EU directives (MDD and AIMDD), and 30 June 2030 for IVDD, EU MDR and EU IVDR devices. What you do need is MHRA registration, a UK Responsible Person if you are based outside the UK, and a post-market surveillance system that meets the GB rules in force since 16 June 2025.

7 steps

Do it yourself: step by step

0 of 7 done

Confirm your device class under UK MDR 2002 and which certificate you hold (EU MDD, EU MDR, or none). This decides your GB deadline
Time
1 to 3 days
Typical cost
£0 to £2,000 regulatory advice (Solvable estimate: up to 2 days of a regulatory consultant at about £1,000 a day)
Who does it
Regulatory lead or consultant
Done when: Written note of class, current certificate, expiry and GB deadline
Write a PMS plan for each device or device family, and set up incident reporting to the MHRA within the current timelines: 2, 10 or 15 calendar days depending on severity
Time
2 to 6 weeks
Typical cost
£0 to £5,000 (Solvable estimate: up to 5 days of regulatory consultancy at about £1,000 a day)
Who does it
Quality and regulatory lead
Done when: PMS plan approved and incident reporting procedure tested
Diary the current deadline for each product. Track when the long-term CE recognition regulations are made, and decide by 18 months before your deadline whether you will rely on CE recognition or move to UKCA through a UK Approved Body
Time
1 day now, review every 6 months
Typical cost
£0 now; UK Approved Body fees vary widely
Who does it
Regulatory lead and board
Done when: Board-approved regulatory roadmap with dates

This problem is Solvable.

Copy this checklist

GB regulatory readiness checklist for medical devices

Free to copy, adapt and use. No sign-up.

Checklist

Product: [Name] Class: [I / IIa / IIb / III / IVD]

Marking and deadline

Current certificate: [EU MDD / EU MDR / EU IVDD / EU IVDR / UKCA / none]
Certificate expiry: [date]
Current GB deadline for this route: [30 June 2028 / 30 June 2030 / earlier of expiry]
Long-term CE recognition (announced 21 October 2026): regulations made yet? [Yes / no, date checked]
Decision on UKCA or CE recognition due by: [date, 18 months before deadline]

Market access basics

UK Responsible Person appointed (if manufacturer outside UK): [name]
MHRA DORS registration complete: [date]
Annual MHRA registration fee paid (due within 90 days of 1 April)
Labelling shows UKRP details where required
Northern Ireland position confirmed: [ ]

Post-market surveillance (GB, in force since 16 June 2025)

PMS plan per device or family, proportionate to risk
Serious incident reporting procedure meets MHRA timelines (2, 10 and 15 calendar days)
Trend reporting process in place
Owner named: [ ]

For software and digital products

Confirmed whether the software is a medical device (intended purpose)
Clinical safety documents (DCB0129) if supplying NHS or providers that require it

Buyer statement (paste into procurement pack)

> [Product] is [CE / UKCA] marked as a Class [ ] medical device under [regulation]. It is registered with the MHRA. Our UK Responsible Person is [name] (if applicable). We operate a post-market surveillance system meeting the Great Britain requirements in force since 16 June 2025. Contact for regulatory questions: [name, email].

Review

Check GOV.UK MHRA guidance every six months for changes to deadlines and CE recognition. Last checked: [date]

Avoid these

Common mistakes

Spending on UKCA marking now, when CE marking is still accepted and long-term recognition has been announced.
Forgetting that a non-UK manufacturer needs a UK Responsible Person before selling in GB.
Selling before MHRA registration is complete.
Running post-market surveillance to the old 30-day incident timeline.
Treating Northern Ireland the same as Great Britain.

Free personal check

Done by Paul Robinson, not software

I'll check your GB regulatory position against the current rules and tell you what is actually needed now

What I need from you

Answers to 8 tap questions
Your device name and class

What you get

What you need now and what can wait
Gaps in registration, UK Responsible Person or surveillance
A plain status line to give buyers

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Check where you stand

Your illustrative estimate

£140,000

Solvable estimate. Rounded to the nearest £500. Updates as you type.

Months of delay

Starting figure 6 (from 6 (Solvable estimate: time lost while unsure of the route)). Change it to match your practice.

Monthly UK revenue at launch

Starting figure £20,000 (from £20,000 (Solvable estimate; use your forecast)). Change it to match your practice.

Unnecessary early certification cost

Starting figure £20,000 (from £20,000 (Solvable estimate: UK Approved Body and consultancy fees for a lower-class device)). Change it to match your practice.

Formula

(months of launch delay × monthly UK revenue at launch) + (cost of unnecessary early UKCA certification)

Variables and defaults

months of delay: 6 (Solvable estimate: time lost while unsure of the route)
monthly UK revenue at launch: £20,000 (Solvable estimate; use your forecast)
unnecessary early certification cost: £20,000 (Solvable estimate: UK Approved Body and consultancy fees for a lower-class device)

Defaults only. Change them in the calculator to use your own numbers.

Assumptions and defaults

months of delay = 6 (Solvable estimate: time lost while unsure of the route)
monthly UK revenue at launch = £20,000 (Solvable estimate; use your forecast)
unnecessary early certification cost = £20,000 (Solvable estimate: UK Approved Body and consultancy fees for a lower-class device)

Solvable estimate. Revenue lost while unsure of the route plus spend on UKCA certification that CE recognition makes unnecessary. Both are avoidable by confirming your route now. With defaults this is about £140,000; treat it as £90,000 to £190,000.

Benchmarks

21 October 2026
The government confirmed long-term recognition of CE-marked medical devices and IVDs in Great Britain. The regulations to put it into law have not yet been made
Source: GOV.UK, Government confirms indefinite recognition of CE marked medical devices
30 June 2028
Current GB deadline for general medical devices certified under EU MDD or AIMDD (or certificate expiry if sooner), until new regulations are made
Source: MHRA, Regulating medical devices in the UK
30 June 2030
Current GB deadline for IVDD, EU MDR and EU IVDR devices, until new regulations are made
Source: MHRA, Regulating medical devices in the UK
15 days
Time limit to report most serious incidents to the MHRA since 16 June 2025, down from 30. Death or unanticipated serious deterioration: 10 days. Serious public health threat: 2 days
Source: MHRA, Vigilance reporting requirements

The divergence from EU MDR/IVDR post-Brexit has created a complex and evolving regulatory framework. UKCA marking requirements, MHRA registration, and the transition timelines are different from every other market and change frequently.

The primary root cause is the post-Brexit divergence from EU MDR/IVDR, leading to a complex and frequently changing UK regulatory framework.
This is exacerbated by limited Approved Body capacity in the UK, creating bottlenecks in the conformity assessment process.
The administrative burden of navigating distinct UKCA marking requirements and MHRA registration, coupled with evolving transition timelines, adds significant structural and systemic challenges for MedTech companies.

A failed UKCA submission for Class I, IIa, and non-high-risk IIb devices costs £11,701 for resubmission, while for high-risk Class IIb, Class III, and active implantables, resubmission costs £22,678. (Morulaa, 2026)

Increased administrative burden and resource allocation for managing dual regulatory pathways (CE and UKCA)
Delays in product launches and market access due to extended conformity assessment timelines and limited Approved Body capacity
Increased operational costs due to the need for dual regulatory compliance and maintaining separate technical documentation for UKCA and CE marking
Significant financial losses from delayed market entry, potentially impacting revenue generation and return on investment for new medical devices
Reduced access to innovative medical devices and advanced treatment options for UK patients due to manufacturers deprioritizing the UK market
Potential delays in patient access to new and improved medical technologies
Damage to the UK's reputation as an attractive market for MedTech innovation and investment, potentially deterring future foreign direct investment
Erosion of trust among international partners and manufacturers due to perceived regulatory instability and divergence from established global standards

What it looks like in practice

Delays in obtaining UKCA marking due to limited Approved Body capacity and extended review times
Increased administrative burden and resource allocation for managing dual regulatory pathways (CE and UKCA)
MedTech companies prioritizing other markets (e.g., US FDA) over the UK due to perceived easier or faster market access
Reduction in the availability of innovative medical devices in the UK market as manufacturers withdraw products or deprioritize UK launches

Paul Robinson

14 years in UK private healthcare

I solve this one for healthcare companies

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Questions

Frequently asked questions

Do we need UKCA marking to sell in Great Britain now?

Not if you hold a valid CE certificate. Long-term recognition of CE marking was confirmed on 21 October 2026. Until the regulations are made, check your certificate type against the current GB deadlines.

We are a UK company. Do we need a UK Responsible Person?

No. The UKRP is for manufacturers based outside the UK.

Is our software a medical device?

It depends on its intended purpose. If it diagnoses, monitors or informs treatment of individual patients, it may be. Get a written view before you market it.

Will the transition dates change again?

They are changing now: the October 2026 announcement needs new regulations to take effect. Check MHRA guidance on GOV.UK every six months and keep your roadmap dated.

Do private hospitals ask about this?

Yes. Clinical governance and procurement teams ask for marking, MHRA registration and PMS evidence before approving a device.

Is this regulatory advice?

No. This is general information. Confirm your device's class and route with a qualified regulatory consultant or your UK Responsible Person.

Last reviewed: 30 October 2026

Sources

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The short answer

Do it yourself: step by step

1Confirm classification and route1 to 3 days · £0 to £2,000 regulatory advice (Solvable estimate: up to 2 days of a regulatory consultant at about £1,000 a day)

2Appoint a UK Responsible Person if needed2 to 4 weeks · £2,000 to £10,000 a year (Solvable estimate: annual UKRP retainer, higher for more products and higher-risk classes)

3Register with the MHRA1 to 4 weeks · Annual MHRA registration fee per GMDN category, charged from 1 April 2026 (check the current amount in DORS or on GOV.UK)

4Set up GB post-market surveillance2 to 6 weeks · £0 to £5,000 (Solvable estimate: up to 5 days of regulatory consultancy at about £1,000 a day)

5Check Northern Ireland separately1 day · £0

6Plan for UKCA or long-term CE recognition1 day now, review every 6 months · £0 now; UK Approved Body fees vary widely

7Tell buyers your status plainly1 hour · £0