Regulating medical devices in the UK
MHRA provides guidance on medical device regulation in the UK. This represents the current regulatory framework and requirements for medical device manufacturers and distributors.
📅 Effective / published: 2026-02-20
Manufacturers and sponsors placing medical devices on the the UK market should review their current compliance documentation against this change. Assess whether your device class, labelling, registration status, or technical documentation is affected. Where gaps are identified, update your files and notify your local representative or importer. Refer to the official source below for the full regulatory text and any transitional arrangements.
View official source ↗