Regulating medical devices in the UK
Updated guidance on the regulatory framework for medical devices in the UK. This guidance document provides current requirements and procedures for medical device approval and compliance.
📅 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 ↗