What do CE marked manufacturers need for UKCA marking and access to the Great Britain market?
UKCA marking is a separate conformity route with its own certificate, assessed by a UK Approved Body designated by the MHRA. CE acceptance in Great Britain ends at certificate expiry or the statutory date, whichever comes first, while registration duties apply throughout.
Overview
Why is a CE certificate not enough for Great Britain?
UK MDR 2002 · UKCA, UK Responsible Person, MHRA registration, Part 4A post-market surveillance under SI 2024/1368
Last updated: September 13, 2026
Great Britain accepts CE marked devices, but only for a defined period and only alongside duties that a CE certificate does not cover.
- The acceptance of CE marked devices is time limited and runs by legal basis. Devices compliant with the MDD or AIMDD may be placed on the Great Britain market until the earlier of certificate expiry and 30 June 2028, IVDD devices until the earlier of certificate expiry and 30 June 2030, and devices compliant with EU MDR or EU IVDR until 30 June 2030. The words that decide a project plan are the earlier of, because a certificate expiring in 2027 moves the real deadline forward by a year.
- Registration and representation apply today, whatever the marking. A manufacturer without a UK establishment must appoint a UK Responsible Person, who registers the device with the MHRA and holds the technical documentation available for inspection. This duty is independent of whether the device carries a CE or a UKCA mark.
- Great Britain post-market surveillance went its own way on 16 June 2025. SI 2024/1368 inserted a new Part 4A into the UK MDR 2002 and applies to every device placed on the Great Britain market, CE marked devices included, so a PMS system written against EU 2017/745 alone no longer answers the UK requirements.
- UKCA conformity assessment runs through a UK Approved Body designated by the MHRA, on the list the agency publishes and updates. Switching route therefore means a second assessment, a second certificate and a second surveillance relationship, not an amended label.
- The regulatory picture is unsettled, and that is itself a planning input. The MHRA consulted between 16 February and 10 April 2026 on indefinite recognition of EU MDR and EU IVDR devices, on aligning the MDD transition with EU timelines and on an international reliance route. The consultation is closed and the outcome had not been published when this page was last reviewed.
Services
How we support you
Great Britain Route Decision
Portfolio level assessment of which devices can stay on CE acceptance, which need UKCA now and which are driven by certificate expiry rather than by the statutory date, documented as a route decision per device family with the evidence behind it.
UKCA Conformity Assessment
Preparation of the UKCA route under the UK MDR 2002: classification under the UK rules, the technical documentation deltas against the existing CE file, selection of a suitable UK Approved Body from the MHRA list and management of the assessment and its findings.
MHRA Registration & Device Data
Reconciliation of the product variants that are really shipped to Great Britain, preparation of the registration data set, and a change procedure that keeps registrations current when variants, labeling or certificates change.
Northern Ireland & Dual Market Strategy
Separation of the Great Britain and Northern Ireland requirements in one portfolio view, so that labeling, registration and conformity decisions are taken per territory instead of per country name.
How we work together
What it comes down to
A CE certificate answers a European question. Great Britain asks three more.
The first is how long. Acceptance of CE marked devices in Great Britain is time limited and runs by legal basis: MDD and AIMDD devices until the earlier of certificate expiry and 30 June 2028, IVDD devices until the earlier of certificate expiry and 30 June 2030, EU MDR and EU IVDR devices until 30 June 2030. Two of those three rules contain a second date that is not in any regulation, namely the expiry printed on the certificate. A manufacturer whose notified body certificate runs to March 2027 has a 2027 deadline for Great Britain, not a 2028 one.
The second is who acts in the UK. A manufacturer without a UK establishment appoints a UK Responsible Person, who registers the device with the MHRA, keeps the technical documentation available for inspection and answers to the agency. Nothing about that duty depends on the marking. It applies to a CE marked device on the day it reaches the Great Britain market.
The third is what happens after launch. On 16 June 2025, SI 2024/1368 inserted a new Part 4A into the UK Medical Devices Regulations 2002. It sets post-market surveillance requirements for devices placed on the Great Britain market, CE marked devices included. A PMS plan written against EU 2017/745 alone therefore covers the EU and leaves a gap in Great Britain.
Where the UKCA route is chosen, the assessment itself is a separate relationship. Third party conformity assessment under the UK rules is performed by a UK Approved Body from the list the MHRA designates and updates, which means a second audit schedule and a second surveillance cycle rather than an extension of the existing one.
| Question | Great Britain | Northern Ireland |
|---|---|---|
| Conformity marking | UKCA, or CE under transitional acceptance | CE, with UKNI where a UK body assessed |
| Underlying rules | UK MDR 2002, as amended | EU 2017/745 and EU 2017/746 |
| Representation | UK Responsible Person for manufacturers outside the UK | Authorized representative under the EU rules |
| Post-market surveillance | Part 4A, UK MDR 2002 (SI 2024/1368) | EU MDR and EU IVDR |
One more thing belongs on the planning table, and it is an open question rather than a rule. Between 16 February and 10 April 2026 the MHRA consulted on recognizing EU MDR and EU IVDR devices in Great Britain indefinitely, on aligning the MDD transition with the EU timelines, and on an international reliance route for devices that Great Britain classifies higher than the EU does. The consultation has closed and no outcome had been published when this page was last reviewed. Around 90 percent of the devices used in Great Britain are CE marked, which is the reason the agency gives for the proposals and also the reason a manufacturer cannot simply wait: the deadlines in force today are the ones that apply until something replaces them.
The work that survives either outcome is the same work. A device by device inventory of legal basis, certificate expiry and UK classification tells a manufacturer which deadline is real. The UKRP mandate, the MHRA registration data and the Part 4A gap analysis are required whatever the agency decides about recognition. Only the last step, the UK Approved Body assessment, depends on the decision, and it is the step with the longest lead time.
Our approach
Our approach
Step
Result
Portfolio & Certificate Inventory
A per device list of legal basis, certificate expiry, UK class and the date on which Great Britain access actually ends.
Route Decision
A documented decision per device family between staying on CE acceptance, moving to UKCA and waiting for the international reliance route, with the trigger that would reopen it.
Representation & Registration
An appointed UK Responsible Person with a written mandate covering the statutory tasks, and MHRA registrations that match the variants actually shipped.
Documentation Delta
The technical documentation and labeling changes needed for the chosen route, derived from the existing CE file rather than rebuilt.
Post-Market System
A PMS plan and reporting practice that satisfies Part 4A of the UK MDR 2002 alongside the EU obligations, with responsibilities assigned between manufacturer and UKRP.
Assessment & Maintenance
Completed UK Approved Body assessment where the route requires it, and a monitoring routine for the pending MHRA decisions.
Common pitfalls
Where projects commonly fail
The headline deadline is planned instead of the certificate date.
The rule for MDD and AIMDD devices reads as the earlier of certificate expiry and 30 June 2028, so a notified body certificate that runs out in 2027 ends Great Britain access in 2027. A roadmap built on the statutory date alone loses the months between the two.
The UK is treated as one market.
Northern Ireland follows EU MDR and EU IVDR and is not covered by the UKCA marking, while Great Britain covers England, Wales and Scotland. A single UK line in a market access plan hides two different sets of obligations.
The EU post-market surveillance system is assumed to cover Great Britain.
Since 16 June 2025 Part 4A of the UK MDR 2002 sets its own requirements for the PMS plan, trend reporting and vigilance, and it applies to CE marked devices on the Great Britain market as well.
The UK Responsible Person is treated as an address.
The UKRP registers the device, holds documentation available to the MHRA and receives complaints and incident information, which only works when the manufacturer has set up the data flow behind the mandate. A mandate without that flow produces a registered device and an unreachable manufacturer.
The pending consultation is read as a reprieve.
The proposals for indefinite recognition of EU MDR and EU IVDR devices closed for comment on 10 April 2026 and no outcome had been published when this page was last reviewed, so the deadlines in force today remain the ones that bind.
The existing EU notified body is expected to issue the UKCA certificate.
Conformity assessment for UKCA is carried out by a UK Approved Body from the MHRA designated list, so the assessment relationship, the audit schedule and the surveillance cycle have to be planned as an addition rather than as an extension.
Regulatory Affairs
Do any of these pitfalls apply to you?
In a first call we assess your situation and say what needs clarifying first in your case. Without obligation, reply usually within one working day.
FAQ
Frequently asked questions
Sources
- MHRA, Regulating medical devices in the UK (guidance, last updated 20 February 2026): https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk
- The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024, SI 2024/1368, made 16 December 2024, in force 16 June 2025: https://www.legislation.gov.uk/uksi/2024/1368/made
- Medical Devices Regulations 2002 (SI 2002/618), as amended
- MHRA, Medical devices: UK approved bodies (list, last updated 17 July 2026): https://www.gov.uk/government/publications/medical-devices-uk-approved-bodies
- MHRA, Medical devices regulations: targeted consultation on the indefinite recognition of CE marked devices, 16 February to 10 April 2026, outcome not published at the time of review: https://www.gov.uk/government/consultations/medical-devices-regulations-targeted-consultation-on-the-indefinite-recognition-of-ce-marked-devices
- MHRA, Implementation of the future regulations (last updated 12 March 2026): https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/implementation-of-the-future-regulations
- MHRA, news release of 16 February 2026, source of the statement that around 90% of medical devices currently used in Great Britain are CE marked: https://www.gov.uk/government/news/mhra-launches-a-consultation-on-indefinite-recognition-of-ce-marked-medical-devices
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Related insights
All insights →Regulations & standards considered
- UK Medical Devices Regulations 2002 (SI 2002/618), as amended
- UK MDR 2002 Part 4A (post-market surveillance in Great Britain)
- SI 2024/1368 (Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024)
- UKCA marking (UK Conformity Assessed) and UK Approved Body assessment
- UK Responsible Person (UKRP) and MHRA device registration
- EU 2017/745 (MDR)
- EU 2017/746 (IVDR)
- Directive 93/42/EEC (MDD) and Directive 90/385/EEC (AIMDD)
- Directive 98/79/EC (IVDD)
- ISO 13485:2016 (QM system)
- ISO 14971:2019 (risk management)
Related topics
IVD Consulting & IVDR Readiness →
IVDR compliance under EU 2017/746, the basis that IVDD devices in Great Britain run out against
International Market Access →
Great Britain in the wider picture of USA, APAC, LATAM and Switzerland
CE Marking →
The EU conformity route whose certificate defines the Great Britain end date
Post-Market Surveillance →
The PMS system that Part 4A of the UK MDR 2002 adds its own requirements to
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