Topic archive
MedTech Current publications and recall entries tagged UKCA.
The UK Department of Health and Social Care published a Health Bill fact sheet outlining primary legislative powers for the MHRA to directly license medical devices and strengthen global safety data sharing.
MHRA has updated its guidance on medicine parallel import licence applications with more detailed instructions on submission, supporting documents, sample scans, packaging, company functions, and its one-RFI assessment approach. The guidance applies to medicines and should not be treated as a medical-device parallel-import licensing pathway.
The Department for Business and Trade updated its Great Britain UKCA / CE market guide on August 21, 2026, with a limited wording change to the declaration-of-conformity template. The wider guide remains a useful operating reference for non-medical products covered by the continued-recognition framework, including CE access, Fast-Track UKCA, marking placement, importer details, and labelling flexibilities.