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Regulatory timeline

The dates that matter.

For UK companies building or deploying health technology.
Last reviewed 8 October 2026.

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Where a date is expected but not yet law, we say so.

28 Nov 2026EUDAMED: devices already on the EU market must be registered.

2 Dec 2026EU AI Act: marking of AI-generated content applies to systems already on the market.

9 Dec 2026EU Product Liability Directive: software and AI placed on the EU market come under strict liability.

Dec 2026MHRA: draft guidance on managing change in AI medical devices. New Great Britain pre-market device regulations are expected to be made (expected, not yet law).

Spring 2027UK: implementation roadmap for the 44 accepted recommendations on regulating AI in healthcare.

30 Jun 2027DSPT: submission deadline for the 2026-27 toolkit.

2 Dec 2027EU AI Act: high-risk obligations apply to stand-alone AI systems.

31 Dec 2027EU MDR and IVDR: transition ends for the highest-risk legacy devices.

30 Jun 2028Great Britain: current end date for devices CE marked under the older EU directives.

2 Aug 2028EU AI Act: high-risk obligations apply to AI in medical devices.

31 Dec 2028EU MDR and IVDR: transition ends for medium-risk legacy devices.

Just passed.

6 Oct 2026The UK Government accepted all 44 recommendations of the National Commission into the Regulation of AI in Healthcare.

11 Sep 2026DCB 0129 and DCB 0160: consultation on revised standards closed. No date yet for the new versions; the 2018 versions still apply.

1 Sep 2026DSPT: the 2026-27 toolkit was released.

2 Aug 2026EU AI Act: general application, including transparency duties.

27 Apr 2026Cyber Essentials: requirements version 3.3 applies to new assessments.

6 Apr 2026DTAC: only the February 2026 form is valid.

A date changes. Your plan changes with it.

Qyro Assurance Planner moves the steps that depend on it.

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