MHRA's draft 2026 regulations would let US, Canadian and Australian approvals reach the GB market

What the draft proposes

The international reliance pathway would let a manufacturer rely on an existing approval from a recognised regulator rather than repeating a full GB conformity assessment. The MHRA's own announcement of the policy names the trusted regulators as Australia's TGA, Health Canada and the United States FDA.

Legal commentary on the draft describes eligible devices being sorted into defined routes by risk and device type, with the manufacturer applying to an approved body for a certificate of international reliance, supported by evidence of the overseas authorisation, quality management system certification and post-market surveillance data. That mechanism comes from commentary on the draft text rather than from an MHRA statement, and the detail may move before the regulations are laid.

What it does not do

When the MHRA announced the reforms in July 2025, its chief executive Lawrence Tallon said the agency was “reducing regulatory duplication, improving traceability and aligning with international best practice”.

Duplication is the operative word. What the reliance route removes is a second assessment of evidence that already exists. It does not remove the evidence.

The reliance route lowers a market access barrier. It does not lower the engineering or evidence burden.

GB-specific safeguards survive. MHRA oversight continues, registration requirements continue, post-market surveillance obligations continue, and the regulator retains the ability to intervene where safety concerns arise.

For software-bearing devices in particular, nothing in the draft reduces what a manufacturer must be able to show about how that software was developed, verified and is maintained in service. A reliance certificate is a route to market, not a substitute for a technical file.

A note on UKCA marking

Reporting on the draft often pairs the reliance route with the end of UKCA marking. The two are not the same change. The MHRA's own position, stated in July 2025, is that it “will support removing the requirement for physical UKCA markings on products and packaging once unique device identification requirements are in place”. That is a general labelling change tied to UDI rollout, applying across the GB market, not a feature of the reliance route.

The post-market half is already live

The pre-market reforms are still in draft. The post-market regime is not.

A new post-market surveillance regime came into force in June 2025, introducing Part 4A to the Medical Devices Regulations 2002 via SI 2024/1368, setting out clearer, more risk-proportionate obligations for manufacturers. Separately, an annual registration fee based on Global Medical Device Nomenclature categories took effect on 1 April 2026, following the MHRA's statutory fees consultation.

Manufacturers waiting for the pre-market picture to settle before acting should note that the post-market obligations have applied for over a year.

Timing

This is where the reporting gets muddled, because there are two dates and they are far apart.

The draft amendment is expected to be adopted in December 2026 and to come into force in June 2027, subject to Parliamentary approval. The international reliance pathway itself is anticipated to take effect in 2028.

Those dates come from legal commentary on the draft, not from the MHRA. The agency's own published pages set out the policy and the consultation but do not give month-level dates for either milestone. Treat them as informed expectations, and note that the pathway most of the coverage is about is the later of the two.