The UK has announced plans to permanently recognize CE-marked medical devices compliant with the EU MDR and IVDR, removing the previously planned 2030 deadline for CE recognition in Great Britain. UKCA will remain available as an alternative route to market.
For manufacturers, this could mean greater regulatory predictability and avoiding the need for parallel certification processes when accessing markets in England, Scotland and Wales.
However, CE recognition does not remove all UK-specific requirements. MHRA registration and the requirement for manufacturers outside the UK to appoint a UK Responsible Person (UKRP) will remain.
The legislative changes are expected to be implemented before 30 June 2028, subject to parliamentary approval. A welcome step towards a more predictable regulatory environment for the medtech industry.
If you’re planning to enter the UK market or have questions regarding UK-specific regulatory requirements, contact us.
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