The UK is rewriting the rules for placing medical devices on the market and you have until 19 June 2026 to help shape them. Here is what is changing and how to respond to those changes.

Published by Quality First International - 11 June 2026

1. Published: 8 May 2026 on the World Trade Organisation notification portal; opened to stakeholders on 11 May.
2. Survey deadline: 11:59pm (UK time), 19 June 2026.
3. Scope: pre-market rules for medical devices and IVDs entering the GB market.
4. Headline measure: an "international reliance" route using approvals from Australia, Canada and the USA.
5. Also proposed: mandatory UDI, implant cards, closer alignment with international and EU standards, and a software/AI change pathway.
6. Expected timing: made around the end of 2026, with the main rules following roughly six months later, and the international reliance route expected around 2028 (subject to Parliament).

What is the MHRA survey and when is the deadline?

The survey is a stakeholder impact survey. It asks for real-world evidence on the likely costs, benefits, challenges and practical effects of the proposed changes.

The MHRA will use the responses to build its official Impact Assessment and to refine the rules before they become law. In short, this is your genuine chance to influence the final version.

The deadline is 11:59pm (UK time) on 19 June 2026. You can read the proposals and respond through the MHRA stakeholder impact survey on GOV.UK.

What is changing? A closer look at the key proposals

The MHRA has set out a broad package. Here are the changes most likely to affect your work, with our read on what each one means.

1. An international reliance route. Devices already approved by trusted regulators in Australia, Canada and the USA could reach the GB market more quickly, by cutting duplicate assessments. This is the most commercially significant proposal. Important caveat: it is not a free pass. MHRA oversight, registration and post-market duties would still apply, so your GB obligations do not disappear.

2. Closer alignment with international and EU standards. The draft would move GB's essential requirements towards best international practice and bring them closer to the EU's Medical Devices Regulation and IVDR, adapted for UK use. If you already meet EU MDR, you may be a step ahead, though, as we explain below, this alignment is not guaranteed to last.

3. New IVD classification. In vitro diagnostic devices would be classified in line with IMDRF standards which is a risk-based system. For many IVD makers this could change the class of a product and with it the route to market. If you make diagnostics, this is the section to read first.

4. Mandatory UDI. Unique Device Identifiers would become compulsory, so devices can be traced precisely across their whole lifecycle. Expect detailed rules on when a new UDI is needed, for example, after changes to design, intended purpose, software or packaging. Crucially, UK Responsible Persons would carry new duties to submit, verify and maintain UDI data in MHRA systems. If you rely on a UK Responsible Person, make sure they are ready for this step.

5. Implant cards. Organisations that implant devices would have to give patients a card with key information about what was implanted that is improving safety follow-up and transparency.

6. A change pathway for software and AI. The draft is expected to formalise "Predetermined Change Control Plans" (PCCPs), letting manufacturers plan certain software updates in advance, with strong version control, change management and cybersecurity expectations. This sits neatly alongside the EU's separate AI rules. For AI-enabled devices, this is a fast-moving area which our AI technical services team follows closely.

7. Stronger technical documentation retention. Manufacturers would need to keep technical documentation for an appropriate, defined period. This is part of a wider tightening of record-keeping that links to your quality management system.

8. New rules for custom-made devices. Improved traceability and the ability to use electronic prescriptions.

9. Claims must match intended purpose. Manufacturers would have to make sure marketing claims line up with the device's stated intended purpose that is closing the gap between what a device says it does and what it is approved to do.

The 2026 draft does not stand alone. It is the pre-market piece of a much larger reform programme, and it lands while several other changes are already in motion:

1.Post-market surveillance. Tougher PMS rules for GB came into force on 16 June 2025, so manufacturers are already adapting to stronger monitoring and reporting duties.

2. Recognising CE-marked devices. Earlier in 2026 the MHRA consulted on recognising EU MDR/IVDR-compliant devices in Great Britain on a long-term basis, alongside extended transitional arrangements.

3. The end of the "transition era". Together, these moves signal a shift away from temporary, post-Brexit recognition measures towards a standalone, but internationally aligned GB framework.

The MHRA frames all of this within the Government's Life Sciences Sector Plan, which sets an ambition for the UK to become one of the three fastest countries in Europe for accessing MedTech by 2030.

Will the UK and EU rules align or diverge?

This is the question we are hearing most from clients. The draft moves GB closer to the current EU framework , but the EU is, at the same time, working on its own simplification of the MDR and IVDR. If both sides keep changing, the two regimes could continue to drift apart in the detail.

For manufacturers selling into both markets, that means watching two moving targets at once. It is exactly where cross-market experience earns its keep. QFI supports clients on both sides of the Channel — as a UK Responsible Person and as an EU Authorised Representative. Divergence is something we manage daily and not a surprise. (If the EU market is on your radar, our practical EUDAMED guide is a good companion read.)

When will the changes take effect?

Timings are not yet fixed, but the current expectation is:

1. The regulations are made around the end of 2026 (subject to review and approval by Parliament).
2. The main pre-market rules follow roughly six months later — around mid-2027.
3. The international reliance route is expected around 2028.



Because draft legislation must be open for international comment for a set period before it is laid before Parliament, the final text may still change. That is precisely why your survey response carries weight now.

Who should respond and why it matters to you

The MHRA wants to hear from the whole sector: manufacturers, UK Responsible Persons, approved bodies, healthcare providers and patients. It is especially keen to hear directly from manufacturers, who will live with these rules day to day.

Responding matters because:

1. The rules are not final. Evidence you give can change them.
2. The impact is broad. Classification, technical files, labelling, UDI, claims and software all sit in scope.
3. Early sight is an advantage. Firms that read the draft now will plan calmly; latecomers will scramble.
4. It could work in your favour. If you already hold approvals in the USA, Canada or Australia, the reliance route may speed your access, therefore tell the MHRA how.

How to respond to the survey: a practical approach

You do not need to comment on everything. A focused, evidence-based response is more useful than a broad one.

We suggest:

1.Read the draft and the MHRA's guidance questions in full.



2. Map the proposals against your own portfolio note where classification, technical documentation, UDI or claims would change for your specific devices.

3. Gather real numbers likely costs, timescales and resource needs. The MHRA is asking for evidence, not opinions.

4. Be specific about impact explain how a change would help or hinder your route to market.



5. Submit before 11:59pm on 19 June 2026.

How QFI can help

Quality First International has advised medical device manufacturers on European regulatory compliance since 1995. Our founder, Haroon Atchia, brings an MHRA background and serves as Honorary Lecturer at the University of Cambridge and member of the Editorial Advisory Board of the Journal of Medical Device Regulation.

Our clients range from start-ups to multinationals, with deep experience in minimally invasive and cardiovascular products and implants.

For this reform, we can:

1. Assess the impact of the draft 2026 regulations on your specific products and classifications.
2. Help you prepare a clear, evidence-based survey response before the deadline.
3. Get you ready for what's coming :UDI, technical documentation, software change control and stronger post-market surveillance.
4. Support your route to market as your UK Responsible Person.

Book a free 20-minute call and we will assist you with your next steps. 

Get in touch with QFI.