Essential Steps to Achieving Quality and Compliance
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More information18th February 2026
Summary: This guidance sets out clear timelines for the continued acceptance of CE-marked medical devices and in-vitro diagnostics (IVDs) under current UK rules. It explains the transition periods for different device types and risk classes before UKCA marking becomes mandatory or before devices will no longer be recognised. Key points include the dates by which manufacturers must notify the MHRA or take action to maintain market access, and how different classifications (e.g., high-risk versus low-risk) are treated. The document helps manufacturers and importers understand how long CE-marked products can be placed on the Great Britain market and what steps may be needed to align with future UK regulatory requirements.