Serena on UK Policy: Long-Term CE Recognition and What Manufacturers Still Need to Do

On 21 October 2026, the MHRA announced the government's decision to accept CE-marked medical devices and in vitro diagnostic devices in Great Britain on a long-term basis, alongside the continuing UKCA route. This is positive news for manufacturers planning to serve both EU and British markets. MHRA announcement ↗

For me, the value of this policy is greater clarity for market planning—not the removal of compliance responsibilities.

1. Long-term recognition does not make every CE certificate permanent

The government consultation response explains its intention to legislate for indefinite recognition of devices complying with EU MDR and IVDR. For devices complying with the legacy MDD, it intends to align Great Britain's transitional arrangements with EU timelines.

Start by identifying whether your device follows MDR or IVDR, or remains under a legacy transition. Do not interpret long-term CE recognition as an unlimited extension of an old certificate, or abandon existing compliance arrangements based on a news announcement alone. Continue to follow legislative amendments and implementation requirements. Government consultation response ↗

2. CE marking does not replace local compliance

Manufacturers entering Great Britain still need to address:

• MHRA registration: complete the applicable registration before placing devices on the market.
• UK Responsible Person: manufacturers based outside the UK need to appoint a UKRP to fulfil the relevant responsibilities.
• Post-market surveillance: maintain safety monitoring, feedback handling and applicable reporting.

CE marking is an important basis for market access, not a replacement for these tasks. MHRA market-access guidance ↗

3. Confirm the destination before choosing the route

Great Britain (GB) comprises England, Scotland and Wales. This policy concerns that market.

Northern Ireland (NI) follows different medical-device rules. Do not simply transfer a GB plan to NI. When reviewing orders or distribution plans, establish where the product will actually be sold before determining the applicable requirements. MHRA guidance on regional rules ↗

4. Serena's recommendation: check three things first

1. The product: What is the current basis for CE conformity, and which models are covered?
2. The arrangements: Are the UKRP and MHRA registration in place, and do the records match the actual product?
3. Ongoing maintenance: Who follows regulatory changes, certificate status and post-market issues?

A policy announcement need not overturn every existing plan. Equally, long-term recognition is not a reason to overlook ongoing responsibilities.

Policy provides more stable expectations; complete and effective compliance arrangements support continued sales.

If you are planning UK market entry, share your product name, instructions for use and current CE status with Serena. Together with SUNGO's UK team, we can help clarify the next steps.

Specific requirements are subject to product assessment and the competent authority's current regulations.
Official MHRA announcement ↗

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