Indefinite CE recognition in Great Britain could remove the 2030 cut-off for many medical devices and reshape long-term market-access planning. The Medicines and Healthcare products Regulatory Agency has consulted on allowing devices compliant with the EU Medical Device Regulation and EU In Vitro Diagnostic Medical Device Regulation to remain on the Great Britain market without a separate domestic pre-market review (MHRA, February 2026).

What the MHRA has proposed for CE-marked devices

The targeted consultation ran from 16 February to 10 April 2026. The MHRA is analysing responses, and no final outcome has been published. Until the government changes the law, the existing transitional arrangements remain in force (MHRA, July 2026).

Approximately 90%

of medical devices on the Great Britain market remained CE marked when the MHRA prepared the consultation (MHRA, February 2026).

The central proposal would indefinitely recognise devices that comply with the EU MDR or EU IVDR. The MHRA asked whether this should cover every eligible device or only devices placed in the same or a lower risk class under the UK Medical Devices Regulations 2002 than under the corresponding EU rules (MHRA, February 2026).

Which CE devices could receive indefinite recognition?

The proposal focuses on devices compliant with the EU MDR and EU IVDR. It does not automatically make older certificates issued under the Medical Device Directive, Active Implantable Medical Devices Directive or In Vitro Diagnostic Medical Devices Directive permanently valid.

For certain MDD devices, the MHRA separately proposed aligning the Great Britain transition deadline with the EU deadline of 31 December 2028. Under current Great Britain rules, relevant MDD and AIMDD devices can generally remain on the market until the earlier of certificate expiry or 30 June 2028. EU MDR and EU IVDR devices can currently be placed on the market until 30 June 2030 (MHRA, July 2026).

What indefinite CE recognition would not remove

Recognition would not eliminate Great Britain-specific obligations. Manufacturers, or their UK Responsible Persons, would still need to register devices with the MHRA and comply with the UK Medical Devices Regulations 2002.

They would also remain subject to Great Britain’s post-market surveillance requirements, including incident reporting and field safety corrective action obligations. A manufacturer or UK Responsible Person would need to notify the MHRA if an EU MDR or EU IVDR certificate were suspended or withdrawn and stop placing the affected devices on the market (MHRA, February 2026).

Manufacturers based outside the UK would still require a UK Responsible Person. Northern Ireland would remain under a different system because the EU MDR and EU IVDR apply there under the Windsor Framework (MHRA, June 2026).

Why buyers still need independent supplier checks

Indefinite recognition could protect product availability, but it would not make every CE-marked device an equally suitable procurement choice. Buyers should still verify the certificate, notified body, product scope, intended purpose, risk classification and regulatory status before approving a supplier.

The MHRA noted that it does not routinely receive all information held by EU notified bodies, including surveillance audit findings, supplier-monitoring information and technical-file review outputs. This information gap could delay investigations, recalls or corrective actions involving CE-marked devices in Great Britain (MHRA, February 2026).

What manufacturers should do before a final decision

Manufacturers should not assume that indefinite recognition has already been approved. Companies should maintain their existing compliance plans, track certificate validity and continue assessing whether UKCA certification offers strategic value for their product portfolio.

They should also map every device against both EU and Great Britain classification rules. A small number of products may receive a higher classification in Great Britain and could face an international reliance review rather than automatic recognition (MHRA, February 2026).

Practical steps for medical procurement teams

  • Confirm which legislation supports the CE mark: EU MDR, EU IVDR or a legacy directive.
  • Check the certificate number, issuing notified body, expiry status and covered product models.
  • Verify the manufacturer or UK Responsible Person’s MHRA registration.
  • Request evidence of Great Britain post-market surveillance and incident-reporting processes.
  • Add contract clauses covering certificate suspension, regulatory changes, recalls and supply continuity.
Key takeaway: Great Britain may recognise EU MDR and EU IVDR devices indefinitely, but the proposal is not yet law. Buyers and manufacturers should continue working to the current 2028 and 2030 deadlines until the government publishes its final decision.