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CE marking — transitional acceptance in GB

Regulatory basis

CE marking acceptance in GB is a policy position implemented through statutory instruments and DHSC/MHRA announcements, most recently extended by the Government announcement of June 2023 setting the deadline of 30 June 2030. The underlying legal authority is the Medical Devices Act 2021 and the UK MDR 2002 as amended.

Current position: CE marking accepted in GB until 30 June 2030​

Following the UK's exit from the EU, the Government has maintained a transitional policy permitting CE-marked medical devices to continue to be placed on the Great Britain market — rather than requiring immediate UKCA marking.

The current position (as of May 2026):

CE-marked medical devices may be placed on the GB market until 30 June 2030, provided they bear a valid CE mark issued under an applicable EU regulatory framework.

This applies to devices CE-marked under:

  • EU MDR 2017/745
  • EU IVDR 2017/746
  • EU MDD 93/42/EEC (for devices still benefiting from EU MDR transitional provisions)
  • EU AIMDD 90/385/EEC (for AIMDs still on transitional provisions)
  • EU IVDD 98/79/EC (for IVDs still on transitional provisions)

What manufacturers must still do​

Relying on CE marking for GB does not mean regulatory obligations in GB are waived. The following remain mandatory:

1. MHRA registration​

All manufacturers, UKRPs, and authorised representatives placing devices on the GB market must register with MHRA via the Submissions portal — regardless of whether the device bears CE or UKCA marking. This is a separate requirement from CE marking.

2. UKRP appointment​

Non-UK manufacturers relying on CE marking for GB access still need a UK Responsible Person (UKRP) established in Great Britain. The UKRP registers the manufacturer and devices with MHRA.

3. Post-market obligations​

All post-market obligations under UK MDR 2002 apply to CE-marked devices on the GB market:

  • Vigilance reporting to MHRA for incidents in GB
  • Field Safety Corrective Actions
  • Post-market surveillance
  • Distribution records
  • MHRA registration maintenance

4. Labelling​

Devices on the GB market must meet UK MDR 2002 labelling requirements, including identifying the UKRP where applicable. The CE mark appears on the label alongside UKRP information.

What the CE marking transitional acceptance does not cover​

SituationCovered by CE transitional?
CE mark valid but EU certificate expired❌ No — must have a valid, current CE mark
Device not CE-marked but sold in GB before 2021❌ No — legacy sell-through rules applied; new supply requires current compliance
MHRA registration not completed❌ No — registration is required even with CE marking
Devices for the NI marketN/A — CE marking always required for NI regardless of transitional rules
Devices bearing only the UKCA markNot applicable — UKCA is the GB mark; CE marking is the EU/NI mark

Practical strategy for the 2030 transition​

The 2030 deadline will require manufacturers currently relying solely on CE marking for GB to either:

Option A: Obtain UKCA marking via a UK Approved Body

  • Identify the appropriate UKAB (see UK Approved Bodies)
  • Submit application and technical documentation
  • Complete UKAB audit and design dossier review (for higher-risk devices)
  • Obtain UKAB certificate
  • Issue UK Declaration of Conformity
  • Affix UKCA mark

Option B: Maintain CE marking for GB under a mutual recognition or equivalence arrangement If a UK-EU mutual recognition agreement on medical devices is reached before 2030, CE marking may continue to be accepted in GB beyond 2030 without UKCA marking. As of May 2026, no such agreement is in place. Monitor What's New for developments.

Recommended approach: Begin UKCA transition planning now. UKAB capacity is limited and demand will increase significantly as 2030 approaches. Early movers will have greater choice of UKAB and faster turnaround.

Official references​

ReferenceDescription
DHSC announcement, June 2023Extension of CE marking acceptance to 30 June 2030
Medical Devices Act 2021Enabling powers for transitional arrangements
MHRA: Regulating medical devices in the UKCurrent MHRA position on CE/UKCA transitional
UK MDR 2002 (SI 2002/618 as amended)Underlying regulatory framework