On 21 October 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published a press release and the government’s consultation response: the UK government will recognise, on a long-term and indefinite basis, medical devices and in vitro diagnostic devices (IVDs) that hold CE marking under the EU MDR / IVDR for placing on the Great Britain market, with no additional UK pre-market approval required.
The question that has troubled exporting manufacturers for years — “how long can CE marking still be used in the UK?” — finally has an answer. But EVERBIZ reminds you: this is a government decision that still has to be put into law, and none of the UK’s local obligations has been removed. Here is a point-by-point overview.
At a glance
- MDR / IVDR CE certificates: valid long-term in England, Scotland and Wales, with no cut-off date
- MDD legacy devices: the UK deadline will align with the EU (currently 31 December 2028) — not indefinite
- UKCA: retained as an optional UK route
- Unchanged: UK local obligations such as the UKRP, MHRA registration and post-market surveillance
- When it takes effect: through legislative amendments requiring parliamentary approval, planned to be completed before 30 June 2028
1. What happened
The MHRA notes that over 90% of medical devices currently registered in Great Britain carry the CE mark. Requiring all of them to switch to UKCA after 2030, as originally planned, would have created an obvious risk of supply disruption — the main reason the government ultimately chose long-term recognition.
2. Key points of the policy (summarised by EVERBIZ)
2.1 Indefinite recognition: only for EU MDR / IVDR certified devices
CE devices certified under the EU MDR (EU) 2017/745 and the EU IVDR (EU) 2017/746 could previously be placed on the Great Britain market only until 30 June 2030 at the latest. Under the new arrangements this deadline will be removed, while the relevant requirements of regulations 19C, 30A and 44ZB of the UK Medical Devices Regulations 2002 (UK MDR 2002) continue to apply.
2.2 MDD legacy certificates: extended, but not indefinite
Under current UK rules, devices with MDD certificates can be placed on the market only until 30 June 2028, while the EU has extended the MDR transition period for certain devices to 31 December 2028 — a six-month gap. The UK proposes to align its deadline with the end of the EU transition period; MDD devices lawfully placed on the EU or UK market before the transition period ends may continue to be made available in the UK.
2.3 No different treatment based on “classification differences”
An earlier proposal would have required devices classified higher in the UK than in the EU to follow a separate reliance route. That proposal has been dropped: all MDR / IVDR CE-certified devices are treated the same.
2.4 Drug-device combination products
For drug-device combination products regulated as devices (devices incorporating an ancillary medicinal substance), the device part also benefits from this recognition, but the product may still need to meet the relevant requirements of the UK Human Medicines Regulations 2012.
2.5 UKCA retained and to be modernised
UKCA remains the UK’s domestic route to market. The MHRA is updating UKCA requirements through its “pre-market” regulations, including UDI and implant cards for implantable devices and up-classification of certain implants. It is also seeking legislative powers to explore a future licensing regime for software and AI as a medical device.
2.6 Scope: Great Britain ≠ the whole UK
The policy covers England, Scotland and Wales. Northern Ireland continues to apply certain EU rules, and devices there must bear the CE mark. This decision allows the same product to cover the whole of the UK, simplifying supply chains.
CE devices entering Great Britain: what changes and what stays the same
What changes: more certain market access
- MDR / IVDR CE certificates remain valid long-term
No fixed cut-off date; no separate UKCA marking needed - MDD legacy deadline aligned with the EU
Extended from 30 June 2028 to the end of the EU transition period - No separate “classification difference” review route
Devices classified higher in the UK are treated the same - UKCA kept as an optional route
Pre-market requirements to be modernised separately
What stays: UK local obligations
- Appoint a UK Responsible Person (UKRP)
Applies to manufacturers based outside the UK - Register devices with the MHRA
Done by the manufacturer or its UKRP - Meet strengthened post-market surveillance
In force since June 2025, incl. serious incident reporting - English technical documentation and certificates + cooperation with enforcement
Notices under the Medicines and Medical Devices Act 2021
Scope: England, Scotland and Wales (Great Britain). Northern Ireland follows the relevant EU rules.
Figure 1 CE devices entering Great Britain: what changes and what stays the same (compiled by EVERBIZ)
3. Important: recognition ≠ no regulation
The government response is clear: manufacturers selling CE devices in the UK must still comply with the following UK requirements. In EVERBIZ’s experience, this is the area that overseas manufacturers most often overlook.
| Obligation | Requirement |
|---|---|
| UK Responsible Person (UKRP) | Manufacturers based outside the UK must appoint a UKRP, who is responsible for the device’s compliance on the UK market and acts as the MHRA’s point of contact and enforcement |
| MHRA device registration | The manufacturer or its UKRP must register devices with the MHRA; a CE certificate does not replace registration |
| Strengthened post-market surveillance (PMS) | The UK PMS rules in force since June 2025 also apply to CE devices: faster serious incident reporting and proactive reporting across the product life cycle |
| English documentation | Technical documentation and certificates of conformity must be available in English for MHRA review |
| Cooperation with enforcement | Comply with compliance, suspension, safety and information notices under the Medicines and Medical Devices Act 2021; the MHRA can restrict or suspend device supply |
In addition, the MHRA will continue to monitor all devices on the UK market through proactive market surveillance, Yellow Card adverse incident reporting, and the exchange of safety signals with international regulators, and says it will further strengthen enforcement and compliance oversight.
4. Timeline: is it already in force?
Not yet. What has been published is the government’s consultation response. The MHRA will amend the regulations accordingly, subject to parliamentary approval, with the aim of completing this before the earliest transition deadline (30 June 2028). Until the new law takes effect, the current transitional arrangements continue to apply.
Key milestones for UK recognition of CE-marked medical devices
| Date | Milestone |
|---|---|
| 16 Feb – 10 Apr 2026 | MHRA public consultation; 1,056 responses received |
| 21 Oct 2026 | Government publishes its consultation response confirming indefinite recognition |
| To be confirmed | Legislative amendment (subject to parliamentary approval) |
| By 30 Jun 2028 | Legislation to be completed (the earliest transition deadline) |
| 31 Dec 2028 | GB deadline for MDD legacy devices aligned with the EU* |
* Based on the current EU MDR transition deadline; if the EU adjusts it again, the UK intends to follow. Source: GOV.UK / MHRA consultation response (21 October 2026).
Figure 2 Key milestones for UK recognition of CE-marked medical devices (compiled by EVERBIZ)
5. EVERBIZ’s view: what this means for manufacturers
Opportunity: one CE certificate, two markets
Companies whose main market is the EU no longer need a separate budget for UKCA time and costs. With the uncertainty of repeated extensions in recent years removed, the UK changes from a “wait-and-see” market into one that can be confidently built into export plans.
Focus: from “getting certified” to “staying compliant”
With the entry requirements unchanged, the MHRA’s oversight concentrates on the UKRP, registration and post-market surveillance. Lacking a valid UKRP, registration details that do not match the actual product, or failing to report serious incidents on time can all lead to enforcement action and product withdrawal.
Watch out: three common misreadings
- MDD legacy certificates are not covered by “indefinite” recognition — the deadline is only aligned with the EU, so MDR transition must still be completed on time;
- IVDD legacy certificates are not affected by this update; plan the transition to the IVDR under the current arrangements (30 June 2030 at the latest);
- “Indefinite” does not mean “permanent” — the UK retains the power to amend its regulations, and new UKCA rules may gradually cause UK and EU requirements to diverge, so keep monitoring.
6. How EVERBIZ can help
- UK Responsible Person (UKRP) services: UKRP and MHRA device registration through our UK-based partner;
- EU MDR / IVDR compliance: EU Authorised Representative, technical documentation, MDD-to-MDR transition support;
- Post-market surveillance: setting up UK and EU PMS and vigilance systems and writing reports;
- Regulatory monitoring: updates and analysis on the UK, EU and other major markets worldwide.
To assess the route to market for your product in the UK, please contact EVERBIZ.
This article is original content compiled by EVERBIZ, provided for reference only and does not constitute legal advice. Please credit the source when republishing.