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Regulatory change
The UK government and Medicines and Healthcare products Regulatory Agency confirmed on 21 October that eligible EU CE-marked medical devices and in vitro diagnostic devices can continue accessing the Great Britain market indefinitely. The decision applies across England, Scotland and Wales, according to InnoScot Health’s regulatory specialist Elaine Gemmell.
Reduced duplication
Gemmell said the change removes substantial administrative complexity for devices previously facing parallel UKCA and EU CE-marking requirements. Around 90% of medical devices and IVDs had dual approval routes, while the previous arrangements included a June 2028 limit for certain devices compliant with older EU directives.
Industry and patient implications
InnoScot Health views the decision as reducing uncertainty for manufacturers and creating a more stable environment for innovation and investment. Gemmell also said recognition of European assessments could help maintain supply and patient access, while avoiding additional approvals for manufacturers.
Consultation context
The decision followed an MHRA consultation that closed in April 2026 and received more than 1,000 responses from patients, healthcare organisations, industry and others. MHRA chief executive Lawrence Tallon said the change provides patients, the NHS and industry with longer-term certainty over medical-device access.
