MHRA publishes draft 2026 device regulations with a reliance route for FDA-cleared products

MedDevice Startups Staff · May 11 · 2 min read · Via GOV.UK call for evidence

MHRA published the draft Medical Devices (Amendment) Regulations 2026 in May 2026 and opened a stakeholder impact survey on May 11, closing at 11:59pm on June 19. The draft is the pre-market half of the UK framework that has been promised since Brexit, and it is the first version with statutory text to read.

The provision a U.S. startup cares about is the international reliance route. MHRA designated Australia, Canada and the United States as comparable regulator countries, so an approval or certificate from one of those authorities could support Great Britain market access without a full UKCA assessment. The EU is not on that list, though CE-marked devices are separately accepted until June 2028 or June 2030 depending on type, with indefinite recognition still under consultation. The draft also revises classification rules for general devices, active implantables and IVDs toward IMDRF and EU structures, adds a predetermined change control plan pathway for software with explicit cybersecurity duties, and extends technical documentation retention to device lifetime plus ten years, or fifteen for implantables.

Nothing binds yet. MHRA does not expect implementation before 2027, with transitional periods up to three years for devices and five for IVDs. A company with an FDA clearance and UK ambitions should read the reliance conditions now and answer the survey, because the conditions are where the route gets narrow or wide.

Questions & Answers

What is the MHRA international reliance route in the draft 2026 device regulations?

It would let devices approved by regulators in Australia, Canada or the United States reach the Great Britain market through a reliance-based pathway, subject to conditions, rather than a full UKCA conformity assessment. The European Union is not among the designated comparable regulator countries.

When did the MHRA impact survey on the 2026 regulations close?

The stakeholder impact survey opened May 11, 2026 and closed at 11:59pm on June 19, 2026. MHRA asked for evidence on costs, benefits and implementation of the proposed pre-market changes.

When would the UK Medical Devices (Amendment) Regulations 2026 apply?

MHRA does not expect implementation before 2027, with transitional periods of up to three years for medical devices and five years for IVDs, and CE-marked devices accepted until June 2028 or June 2030 depending on device type.

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