Key takeaways
A new era for GB medical device regulation
Post Brexit framework replaces legacy EU-based system towards a modern, lifecycle-focused framework.
Closer alignment with EU Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (EU IVDR) standards
Stronger evidence requirements and updated classification rules, which may result in reclassification and increased compliance obligations for manufacturers.
Introduction of International Reliance Pathway and new transparency
Improving patient safety but increased scrutiny for higher risk devices and stricter evidence requirements.
On 8 May 2026, the Medicines and Healthcare Regulatory Agency (MHRA) published the draft Medical Devices (Amendment) Regulations 2026 (the Draft Regulations). Once finalised, this statutory instrument will update the regulatory requirements for pre-market medical devices and in vitro diagnostic devices entering the Great Britain (GB) market.
As part of the development process of the Draft Regulations, the MHRA launched a call for evidence on 11 May 2026, through both the World Trade Organisation (WTO) portal and the MHRA portal. The call seeks views from WTO members, approved bodies, healthcare providers, and patients for their input on the proposed regulations. The consultation is open until 19 June 2026.
Key proposals
1. Moving away from the retained EU Directive framework
The Draft Regulations propose the establishment of an independent Great Britain framework, making a decisive shift away from the reliance on retained EU Directives.
At present the UK Medical Devices Regulation 2002 (UK MDR), which applies to all products, including digital technologies, which meet the definition of a medical device in Great Britain, remains primarily EU Directive-based. The framework continues to rely heavily on retained EU medical device Directives, creating a hybrid system that reflects legacy EU requirements rather than a fully domestic regulatory structure.
The Draft Regulations seek to end this dependency by removing the embedded EU Directive structure and replacing it with a distinct GB-specific framework. As part of this structural redesign, new GB classification schedules will be introduced for general medical devices. These will replace the existing EU Directive-based classification rules, aligning more closely with modern MDR/ IVDR-style risk principles while retaining UK regulatory control. In practice this may result in reclassification of certain devices, and manufacturers will need to consider whether products may fall into higher or lower risk classes under the new GB framework. Some critics have stated that they consider that the reclassification rules are potentially a regulatory omission, particularly in regard to classification of software.
The shift away from the EU Directive framework enables the MHRA to embed a more lifecycle-based approach to regulation, extending oversight beyond pre-market conformity assessment to include clinical evaluation, post-market surveillance and ongoing performance monitoring, reinforcing a more proactive model of regulatory control.
2. International Reliance Pathway
A new regulatory mechanism enabling medical devices approved by overseas regulators to access the GB market.
Today Great Britain has no formal international reliance mechanism for medical devices that may be certified overseas. Market access is limited to either obtaining UKCA marking, or relying on continued CE marking acceptance under transitional agreements.
The Draft Regulations therefore introduce a new third pillar of market access to sit alongside the UKCA and CE routes. International Reliance will be based on approval by the United States (FDA routes), Canada (Health Canada MDR) and Australia (TGA). Eligibility will be subject to MHRA recognition criteria and conditions and the MHRA will also retain discretion to impose additional conditions, limitations or post-market requirements where reasonable.
Practically, the International Reliance Pathway has the potential to enable faster routes to market for many devices, lower regulatory costs and administrative burdens and improve global regulatory alignment for transnational medical device product strategies.
This represents a shift from reliance being applied on a case-by-case basis, to being expressly embedded within primary legislation. In doing so, this makes Great Britain one of the first jurisdictions to embed reliance explicitly in primary device legislation, rather than treating it as an informal policy choice.
3. Strengthened evidence and documentation
Clinical evidence and equivalence
The concept of equivalence is transformed into a defined legal test that must be objectively met. Currently, manufacturers can rely on existing clinical data from older or similar products, claim equivalence with limited justification and use clinical data from devices that are either no longer on the market, or have not been approved in the UK market.
The Draft Regulations now require manufacturers to satisfy all three forms of equivalence: (i) technical, (ii) biological, (iii) clinical. For higher-risk devices falling under classes IIb and III, the evidence threshold is intentionally much higher, enabling approved bodies and the Secretary of State to have clearer grounds to reject equivalence claims. This represents a significant departure from current practice where equivalence can be supported more flexibly.
Technical documentation
The Draft Regulations introduce a more detailed and standardised requirement for technical documentation, that is closely aligned with EU MDR technical documentation requirements.
Whilst technical documentation is already required under the current regulations, the current framework does not prescribe format, limits inspection timelines and applies shorter retention periods.
The Draft Regulations impose that documentation must now be in English and searchable. The retention period for these documents is also increased to 15 years for implantable devices and 10 years for all other devices.
4. Software, AI and expanded scope
Pre-determined Change Control Plan (PCCP)
The introduction of the PCCP enables pre-approved software modifications, addressing long-standing difficulties with software-driven and AI-enabled devices.
Under the current UK MDR, software changes trigger significant change assessments and require re-certification by an Approved Body. There is no formal legal mechanism to distinguish controlled, low risk updates, from changes that materially affect safety or performance. Practically this means that manufacturers delay updates and innovation slows post-market entry.
The PCCP defines, in advance, what software changes are permitted and how these changes will be assessed, controlled and documented. The PCCP is optional for manufacturers, however it will be an advantageous tool for software-driven devices that are encountering delays with software approvals under the current framework.
Expanded scope and definitions
The Draft Regulations also modernise the regulatory framework to better reflect current technologies and commercial practices. Key updates include:
explicit recognition of software as a medical device
expansions of the concept of intended purpose to include promotional and sales materials
introduction and clarification of definitions such as:
clinical evaluation
lifetime of the device
Unique Device Identification (UDI).
These changes provide greater clarity for manufacturers developing digital health and AI-driven technologies.
5. Patient transparency and market controls
Implantable device obligations
The Draft Regulations introduce a deliberate move toward patient-centred transparency and long-term traceability for implantable medical devices. Under the Draft Regulations, every implantable medical device must now be accompanied by a patient leaflet and a physical implant card as a legal requirement. This will mitigate the current inconsistencies in patient-facing implant information, ensuring consistent access regardless of the healthcare setting.
Marketing and claims
The Draft Regulations introduce medical device specific offences, including misleading or unsubstantiated claims, claims beyond the intended purpose and promotional misuse during clinical investigations. These offences will be directly enforceable under medical device legislation.
This means that manufacturers are likely to face increased scrutiny in product development and in how their devices are marketed to both clinicians and patients.
For information on how we can support medical device businesses, find out more about our Healthtech expertise.
This article was co-authored by Trainee Solicitor, Fiona Broad.
