The UK Health Bill and a potential Great Britain medical-device licensing regime

A proposed shift from conformity assessment toward licensing

On 1 September 2026, the Medicines and Healthcare products Regulatory Agency (MHRA) announced that the Government had tabled Health Bill amendments in three thematic areas:

• expanded information-sharing powers;
• mechanisms intended to make medicines and medical-device legislation easier to update;
• and enabling powers for the future development of a medical-device licensing regime.

The MHRA expressly states that the proposals do not introduce immediate regulatory changes and would require further policy development and consultation even if Parliament agrees to the enabling legislation.

The underlying parliamentary text confirms that this is not merely a policy aspiration. Government New Clause 94 (NC94), tabled for Commons Report Stage, would insert an extensive new licensing chapter into Part 4 of the Medicines and Medical Devices Act 2021 (MMD Act). It would permit the Secretary of State to make regulations establishing product and personal licenses for defined medical-device activities in Great Britain.

At the article date, the Health Bill remained in Parliament. The House of Commons Library recorded that the Bill had completed Public Bill Committee on 16 July 2026 and was scheduled for Commons Report Stage on 7 September 2026. Consequently, neither NC94 nor the related reform package has yet changed the law.

Updated on 7 September 2026: Report Stage was allocated two days rather than one. The first day, 7 September, covered clauses 1 to 61 and schedules 1 to 8. The second day, 8 September, covers clauses 62 to 81 and schedules 9 to 12, which include the provisions on medicines and medical devices, followed by all other outstanding new clauses. NC94 would insert a new chapter into Part 4 of the Medicines and Medical Devices Act 2021, so it falls to the second day. The statement above therefore still holds, and the outcome for NC94 should be read from the second day's proceedings before anything in this article is treated as settled.

The present GB baseline: conformity assessment, registration and transitional CE recognition

A future licensing discussion must start from the system it could replace or reshape. Medical devices in Great Britain are currently regulated principally under the Medical Devices Regulations 2002 (UK MDR 2002), as amended. Manufacturers must register devices with the MHRA before placing them on the GB market. A manufacturer established outside the United Kingdom must appoint a UK Responsible Person (UKRP), which registers and performs specified compliance functions for the manufacturer.

The current GB system supports both a UKCA pathway and, during defined transition periods, acceptance of qualifying CE-marked devices. Where UKCA third-party assessment is necessary, it is performed by a UK Approved Body; certain non-sterile, non-measuring Class I devices and general IVDs may be self-certified. UK Approved Bodies cannot issue CE certificates.

The current CE transitional arrangements are product- and legal-basis-specific. Qualifying devices compliant with the former EU MDD or AIMDD may generally be placed on the GB market until the earlier of certificate expiry or 30 June 2028. Qualifying IVDD devices may generally be placed until the earlier of certificate expiry or 30 June 2030. Devices compliant with the EU MDR or IVDR, including qualifying custom-made devices, may generally be placed until 30 June 2030. These dates are current rules, not dates proposed by NC94.

What NC94 would actually authorize

Product licenses and personal licenses

NC94 would insert a new Chapter A1, "Medical Devices Regulations (Great Britain)," into Part 4 of the MMD Act. It would permit the Secretary of State to make regulations prohibiting specified activities unless they are undertaken under a license. The two proposed license types have distinct functions.

A product license would authorize supply or advertising of a medical device of a description specified in the license. A personal license would authorize the holder to manufacture, import, supply by wholesale dealing or conduct a clinical investigation in relation to a device of a specified description. The wording also captures a transfer of devices from Northern Ireland to Great Britain within the definition of importing.

"This introduces a new power to make regulations for the licensing of medical devices, which is intended to replace the current regulatory regime in Great Britain." Member's explanatory statement to Government NC94

This drafting matters. The proposal is not limited to a voluntary MHRA review for novel products, nor is it limited to products. It provides a possible legal basis for both product-level authorization and actor-level licensing across the device supply chain. The policy announcement calls this a future medical-device licensing regime and says the approach under exploration could require a license issued by the MHRA for devices placed on the GB market through a domestic route rather than reliance on third-party conformity assessment.

Strictly speaking, NC94 says that licenses are issued by the Secretary of State, not by the MHRA. In a practical regulatory model, the MHRA would be expected to administer or operationalize the regime, consistent with its existing role and the Government's announcement. However, descriptions of a "direct MHRA license" should be treated as policy shorthand until the final regulations allocate functions explicitly.

Broad enabling powers, limited current design detail

NC94 would permit future regulations to establish the full license lifecycle. The statutory power expressly covers grant criteria, license conditions, duration, renewal, variation, suspension, revocation, transfer, public registers, temporary public-health exemptions, enforcement, criminal offences and fees. The exact substantive requirements are not set in NC94.

The proposed conditions are significant because they indicate the kind of ongoing regulatory relationship a licensing model could create. Conditions may require monitoring, investigation or evaluation of safety or performance; provision of information to the Secretary of State; and appointment of an individual resident in the UK who is authorized or required to act for the license holder in specified matters.

The amendment specifies an overarching objective of safeguarding public health. In determining whether action contributes to that objective, the Secretary of State must have regard to safety, availability and the UK's attractiveness for research, development, manufacture and supply of medical devices. These statutory considerations point to an intended balancing of patient safety and market access, but they do not amount to a settled risk framework.

Does the Bill establish risk tiers?

No. The MHRA announcement says that any future system would be proportionate to risk, with different scrutiny levels depending on the product. NC94 itself contains no device classification structure, risk-class mapping, priority pathway, evidence threshold or review timeline. It is therefore accurate to identify a risk-proportionate intention, but premature to assume that EU MDR classes, UKCA classes or any particular software or AI categories will determine the future licensing workflow.

The same caution applies to software and AI medical devices. The MHRA identifies advancing technologies, including software and AI devices, as a reason for seeking a more adaptable framework. That is a credible signal of policy relevance; it is not a bespoke AI-device licensing rule.

Information-sharing reforms: wider gateways, not unrestricted disclosure

The Government's first reform theme is supported by two separate proposed clauses. NC95 would create a broader information-sharing gateway for human medicines, while NC98 would expand the purposes for which the Secretary of State can disclose information relating to medical devices. The permitted purposes include facilitating public-authority functions, relevant medicines and device activities, international agreements or arrangements, civil proceedings, criminal enforcement and public warnings.

The provisions are not a general permission to disclose all regulatory information without restraint. For international-sharing purposes, patient information cannot be disclosed without the relevant person's consent. Disclosure of commercially sensitive information requires the Secretary of State or relevant authority to consider it appropriate after taking account of the public interest and the interests of the affected person. The public-health objective, including safety and availability, must be considered where relevant.

For manufacturers, the immediate consequence is none, because the clauses are proposed only. If enacted, the operational issue will be the governance of more frequent or broader information flows among authorities, partners and regulated actors, particularly where safety signals, shortages, post-market data or international regulatory cooperation are involved.

Dynamic standards, international recognition and parliamentary control

The reform narrative sometimes risks overstating the legal effect of the Bill's dynamic mechanisms. The proposals do create routes for a more responsive regulatory architecture, but not a blanket automatic adoption of every revised technical standard or international guideline.

Clause 70 of the Bill as amended in Committee would allow regulations under the MMD Act to refer to international agreements and standards as they have effect from time to time. It would also allow reference to UK standards that appear in a Secretary-of-State list published from time to time. Government Amendment 65 would standardize the formulation of those dynamic references. Clause 71 similarly shifts the definition of mutual recognition agreement in the UK MDR 2002 away from a fixed country schedule toward countries specified in a list published by the Secretary of State from time to time.

This is a meaningful flexibility tool. In principle, a regulation may adopt a reference that tracks later revisions of an international standard, reducing the need for repeated domestic amendments merely to keep a referenced document current. But a new or amended GB regulatory obligation will still depend on the scope and wording of the underlying regulation. It is not correct to say that all technical changes simply become law without further action.

The consultation and parliamentary-procedure provisions are also more differentiated than a simple "unless Parliament objects" formulation implies. Clause 72 requires the relevant authority, before making Part 2 or Part 4 regulations, to conduct a public consultation or consult persons it considers appropriate. This allows a proportionate route for less significant measures but does not abolish consultation.

Clause 73 permits the negative procedure only for defined categories, such as particular fees and specific technical or administrative amendments. Other Part 4 regulations are generally subject to draft affirmative procedure. NC99 would likewise make new Part 4 regulations subject to draft affirmative procedure except for narrowly limited civil-sanctions supplemental provisions. Thus, the core regulations that would create a GB licensing regime should not be portrayed as capable of taking effect solely through a lightly scrutinized negative procedure.

Great Britain versus Northern Ireland: separate regulatory paths remain essential

The potential licensing regime concerns Great Britain, defined as England, Scotland and Wales. It does not convert Northern Ireland into a GB licensing jurisdiction. The MHRA confirms that Northern Ireland continues to apply the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) under the Windsor Framework, maintaining its particular dual-market-access context.

NC101 would create a power to restate Northern Ireland medical-device law, including the relevant Northern Ireland regulations and EU device regulations, with limited changes designed to resolve ambiguities, remove anomalies or improve clarity and accessibility. Its explanatory statement contrasts that restatement power with Great Britain, where it says the existing law would be replaced by the new licensing regulations. This supports the conclusion that the Government is deliberately preserving a distinct NI architecture.

The distinction has real supply-chain significance. NC94 defines importation for a personal license to include both entry from outside the UK into Great Britain and removal of devices from Northern Ireland to Great Britain. A business with an NI/EU and GB strategy should therefore track the future treatment of NI-to-GB movement, even though no new license is required today under NC94.

Interaction with UKCA, CE recognition and international reliance

The future relationship among possible licenses, UKCA, CE recognition and international reliance is the single most consequential unresolved design issue.

The MHRA is explicit that the UKCA regime will remain in place while a future model is developed. It also states that policy intentions relating to international reliance and recognition are unchanged. The MHRA's policy-intent statement envisages alternative GB routes using approvals from other countries and Medical Device Single Audit Program (MDSAP) certificates alongside UKCA; it describes CE recognition as currently time-limited and says manufacturers would retain the UKCA option.

NC94's explanatory statement nevertheless says the licensing power is intended to replace the current GB regime. The most defensible interpretation is therefore not that a direct license is already an additional optional route, but that the Bill would give Government the capacity to design a future replacement or hybrid architecture. Possible outcomes include a licensing endpoint supported by third-party assessments, differentiated routes by risk, reliance-based licensing, an optional domestic route, or more extensive replacement of UKCA conformity assessment. The documents reviewed do not select among these models.

Operational implications for the sector

Manufacturers and UK Responsible Persons

There is no present reason to amend a quality-management system, technical-file process, registration SOP or GB market-access strategy solely because NC94 is tabled. Existing registration, UKRP and conformity or CE-recognition obligations remain applicable.

However, manufacturers should begin portfolio mapping. In particular, they should identify products marketed only in GB, products marketed in both GB and NI/EU, products that currently depend on a UK Approved Body, and products that could be viewed as strategically significant for domestic licensing, including high-risk, novel, software-based or AI-enabled products. This is not an implementation action; it is proportionate scenario planning.

Non-UK manufacturers and UKRPs should examine whether current UKRP contracts, authority letters and data-access arrangements could support a future license-holder contact role. NC94 permits conditions requiring a UK-resident individual authorized or required to act for a license holder. The amendment does not say this person must be the UKRP, but the functional overlap is sufficiently apparent to warrant monitoring.

UK Approved Bodies

UK Approved Bodies remain essential where third-party UKCA conformity assessment is currently required. Yet NC94 raises a structural question: whether Approved Bodies will remain the principal assessors for a domestic route, contribute evidence to an MHRA-led licensing decision, perform defined outsourced technical review functions, or see their role narrowed for parts of the market. None of those outcomes is determined by the proposed amendment.

Software and AI medical-device companies

The MHRA expressly identifies software and AI medical devices as technologies that a more adaptable framework should be able to address. A licensing model could, in theory, allow conditions tailored to change management, real-world performance monitoring, data governance or periodic reassessment. But these are analytical possibilities, not proposed legal requirements. Companies should avoid redesigning their compliance models until there is a consultation text or draft secondary legislation.

Fees and lifecycle obligations

Fees and ongoing obligations are not speculative in the abstract: NC94 expressly permits application fees and license-holder fees, along with license conditions for safety and performance monitoring and information provision. But no draft tariff, payment schedule, portfolio basis or renewal interval has been published for a future device license.

The MHRA's separate 2026 statutory-fees consultation concerns cost recovery and other services from April 2027, including a phased update to the medical-device post-market-surveillance fee. Its public summary does not establish a new NC94 product-license tariff. The two issues should not be conflated.

Recommended regulatory watchlist

The appropriate immediate response is monitoring, not operational conversion. An effective watchlist should focus on the sequence by which an enabling power could become a functioning licensing system.

Conclusion

The United Kingdom is not yet introducing an operative direct MHRA license for medical devices. It is seeking legislation that could enable a materially different GB regulatory architecture. The proposed power is deliberately broad: future regulations could turn product and personal licenses into the legal basis for supply, advertising, manufacture, import, wholesale distribution and clinical investigation, with potential fees, post-market conditions, UK-resident representation, enforcement and public registers.

That breadth makes the development strategically important for manufacturers, UKRPs, UK Approved Bodies and businesses with software, AI or GB-specific market plans. Yet it also makes precision indispensable. The Bill does not set a final risk model, evidence package, tariff, timetable, migration plan or relationship with UKCA, CE recognition and international reliance. It does not change current obligations. The sound response is therefore to preserve current compliance arrangements while building a structured watch program around parliamentary progress, consultation and the eventual secondary legislation that would determine the real regulatory burden.