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Recent regulatory changes

note

This page reflects the regulatory position as of May 2026. UK medical device regulation is actively evolving — always verify against current MHRA communications at gov.uk.

Current key regulatory positions (May 2026)​

CE marking accepted in GB until 30 June 2030​

Following the Government announcement of June 2023, CE-marked medical devices that are lawfully CE marked under EU MDR, EU IVDR, or the legacy EU directives continue to be accepted on the GB market until 30 June 2030. MHRA registration remains mandatory regardless.

Windsor Framework in effect​

The Windsor Framework (March 2023) remains in force, governing Northern Ireland's continued alignment with EU MDR 2017/745 and EU IVDR 2017/746. No material changes to NI medical device rules have occurred since March 2023.

MHRA reform programme ongoing​

MHRA continues to develop the next generation of UK medical device regulation using powers in the Medical Devices Act 2021. MHRA has consulted on:

  • A new, more prescriptive clinical evidence framework
  • A full UK UDI system
  • Strengthened post-market surveillance obligations
  • Clarified economic operator provisions

Implementation timelines have not been finalised as of May 2026. Monitor MHRA consultations for updates.

EU IVDR phased rollout continues to affect NI​

The EU IVDR 2017/746 (applying in Northern Ireland) continues its phased implementation timeline. Manufacturers of IVDs placed on the NI market should monitor the IVDR transition milestones for their device class.

How to stay current​

Official references​

ReferenceDescription
MHRA: Regulating medical devices in the UKCurrent MHRA position summary
MHRA email updatesgov.uk/email-signup
MHRA publicationsgov.uk/government/publications?departments=mhra
MHRA consultationsgov.uk/government/consultations — filter by MHRA