UK MHRA International Reliance Pathway: Draft Regulations 2026 Analysis

MHRA's draft Medical Devices Regulations 2026: International Reliance Pathway for US, Canada, and Australia approvals, IVD reclassification, PCCPs for AI software, and what manufacturers must prepare.

The Biggest Post-Brexit Regulatory Overhaul Is Here

On May 8, 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published the draft Medical Devices (Amendment) Regulations 2026 on the World Trade Organisation notification portal — the most significant overhaul of the GB medical device framework since Brexit. The draft introduces an International Reliance Pathway (IRP) that allows devices authorized in the US, Canada, and Australia to access the Great Britain market without UKCA marking; a formalized Predetermined Change Control Plan (PCCP) pathway for AI and software devices; revised IVD classification rules aligned with risk-based global frameworks; mandatory Unique Device Identifiers; and tighter post-market surveillance obligations (Hogan Lovells; Latham & Watkins; Hill Dickinson).

The MHRA simultaneously opened a call for evidence via an impact survey, open until June 19, 2026. Adoption is anticipated in December 2026, with core provisions entering into force in June 2027 and the International Reliance Pathway becoming operational in mid-2028 (Latham & Watkins; BioSlice Blog).

This article examines every major proposal, explains what changes for each category of device, and sets out the practical steps manufacturers, UK Responsible Persons, and regulatory teams should take now.

Why This Reform Is Happening Now

Since Brexit, the UK has operated its medical device regulatory framework under the retained EU law established by the Medical Devices Regulations 2002 (as amended). The EU itself moved forward with the Medical Device Regulation (EU MDR 2017/745) and In Vitro Diagnostic Regulation (EU IVDR 2017/746), creating a widening gap between the EU's updated requirements and the UK's legacy framework.

The MHRA has been consulting on the future of UK medical device regulation since 2022, with several rounds of public consultation. The response published in July 2025 confirmed the direction of travel: the UK intends to build a standalone regulatory framework that draws on EU MDR/IVDR concepts and IMDRF principles, but operates as a distinct system with its own market access routes (MHRA Government Response, August 2025).

The February 2026 consultation on indefinite recognition of CE-marked devices — which closed April 10, 2026 — proposed three pathways: automatic indefinite recognition of CE-marked devices compliant with EU MDR/IVDR; international reliance for CE-marked devices in higher UK risk classes; and a six-month extension of the current transitional period from June 30, 2028, to December 31, 2028. The MHRA has not yet published its formal response to that consultation (Latham & Watkins, March 2026).

The May 2026 draft regulations are the legislative expression of these policy decisions. Their publication coincides with the European Commission's own proposals to simplify the EU MDR and IVDR, leaving open the question of how closely the UK reforms will ultimately align with those amendments — or whether regulatory divergence will increase (Hogan Lovells; Reed Smith).

The International Reliance Pathway

Scope and Mechanics

The International Reliance Pathway is the centrepiece of the draft regulations. It creates a new, standalone route to the GB market that sits alongside UKCA marking and CE marking — a "third pillar" of market access (Hill Dickinson).

Under the IRP, manufacturers of eligible devices can apply for a Certificate of International Reliance from a UK-approved body. The application must be supported by evidence of overseas authorization from a designated Comparable Regulator Country (CRC), quality management system certification, and relevant post-market surveillance data (BioSlice Blog; PatientGuard).

Which Countries Qualify

The draft regulations designate three CRCs:

Country	Regulatory Authority	Qualifying Frameworks
United States	FDA	510(k), De Novo, PMA
Canada	Health Canada	Medical Device Regulations (MDR)
Australia	TGA	Australian Register of Therapeutic Goods (ARTG)

Notably, the EU is not included as a CRC. The MHRA deferred implementation of reliance routes for CE-marked products following strong consultee demand for indefinite recognition, and will undertake further consultation. In the interim, CE-marked devices continue to be accepted on the GB market: until June 2028 for most devices, or until June 2030 for devices that comply with EU MDR or IVDR (Reed Smith; Hogan Lovells).

The FDA–MHRA Dimension

In October 2025, the MHRA and FDA announced a formal collaboration to align regulatory processes for medical devices and reduce duplication. In April 2026, the two agencies deepened this commitment, announcing strengthened cooperation including exploration of mutual recognition mechanisms and streamlined approval processes. Devices cleared under FDA frameworks (510(k), De Novo, PMA) are expected to benefit from reliance routes active from 2027 (Reed Smith; LFH Regulatory).

Risk-Based Routes

The IRP categorizes eligible devices into defined routes based on risk and device type. Based on the MHRA's consultation response and draft regulations, the routes are structured as follows:

Route 1: Lower-risk devices. Devices authorized in CRC jurisdictions may qualify for a streamlined review, where the approved body primarily verifies the overseas authorization and QMS certification rather than conducting its own full assessment.
Route 2: Moderate-risk devices. Devices require more substantive review by the approved body, which must confirm equivalence rationale, assess UK-specific requirements, and verify post-market surveillance data.
Route 3: Higher-risk devices. Class III devices, Class D IVDs, and implantable devices undergo the most thorough review. The approved body must confirm compatibility with UK electrical requirements for active devices, review PCCP documentation for software devices, and for devices incorporating ancillary medicinal substances, obtain an opinion from the Secretary of State.

Manufacturers must apply for a Certificate of International Reliance through an approved body, and the MHRA retains discretion to impose additional conditions, limitations, or post-market requirements where reasonable (BioSlice Blog; Emergo by UL; MHRA Government Response).

What the IRP Does Not Cover

The IRP does not replace UKCA certification. A certificate of international reliance grants market access but is a distinct legal instrument. Manufacturers must still comply with UK-specific labelling requirements, post-market surveillance obligations, and UK Responsible Person appointment (LFH Regulatory).

IVD Classification Changes

The draft regulations propose aligning UK IVD classification rules with globally recognized risk-based frameworks, moving away from the retained EU IVD Directive list-based approach toward a rule-based system similar to EU IVDR.

Key changes include:

Reclassification of many IVDs into higher risk classes. Devices currently self-classified under the EU IVD Directive may move into classes requiring notified body involvement under the new UK framework.
Risk-proportionate classification rules. The new rules draw on EU IVDR and IMDRF concepts but are modified for the UK framework.
Transitional provisions. The MHRA's IVD Medical Device Roadmap, published December 15, 2025, outlines planned priority deliverables for the IVD work programme through mid-2027 (GOV.UK).

Manufacturers should map their IVD portfolios against the proposed classification framework now, identifying products likely to be reclassified upward and planning for new conformity assessment and QMS obligations (Reed Smith; PatientGuard).

PCCPs for AI and Software Devices

The draft regulations introduce a formal Predetermined Change Control Plan (PCCP) pathway for software medical devices. This is intended to streamline regulated software updates, allowing certain modifications to be implemented without full re-certification, provided they fall within the scope of an approved plan (BioSlice Blog; JD Supra).

Key elements:

PCCPs are optional. Manufacturers choose whether to include a PCCP in their technical documentation.
Approved body review required. The PCCP must be reviewed and approved by a UK-approved body as part of the conformity assessment.
Scope defines permissible changes. The PCCP describes what modifications can be made and how they will be assessed — supporting agile development for software medical devices.
Explicit cybersecurity obligations. The regulations include new cybersecurity requirements for software devices alongside the PCCP framework.

This approach mirrors the FDA's evolving PCCP framework for AI/ML-enabled devices and reflects a growing international consensus that regulatory frameworks must accommodate iterative software development without compromising safety (PatientGuard; Learnova).

Other Key Proposals

Unique Device Identifiers (UDI)

The draft regulations make UDI mandatory for medical devices and IVDs placed on the GB market, strengthening traceability and supporting post-market surveillance. This aligns with the EU MDR's UDI requirements and global trends toward device identification harmonization (JD Supra).

Implant Cards

New obligations require certain implantable device information to be provided to patients and retained by healthcare institutions, reflecting a broader emphasis on traceability and patient transparency (BioSlice Blog).

Essential Requirements Reanchored

The draft regulations re-anchor UK essential requirements, drawing on EU MDR and IVDR concepts as modified for the UK framework. This represents a deliberate effort to maintain alignment with international best practice while establishing UK-specific adaptations (JD Supra; Hill Dickinson).

Technical Documentation Retention

Expanded technical documentation requirements include extended retention periods: device lifetime plus 10 years for general devices, and 15 years for implantable devices (JD Supra).

Electronic Instructions for Use (eIFU)

Broader circumstances under which electronic IFUs may replace paper IFUs, modernizing labelling requirements and reducing manufacturer burden (JD Supra).

Claims and Equivalence

Tighter rules on claims of equivalence to existing devices, and new controls on misleading or unsubstantiated device claims (JD Supra).

Northern Ireland

The proposed approaches apply to the GB regulatory framework only. Northern Ireland continues to follow the EU MDR/IVDR under the Northern Ireland Protocol. Manufacturers with all-UK supply chains must evaluate whether their regulatory strategy provides uninterrupted coverage across both GB and Northern Ireland (Reed Smith; MHRA Government Response).

Implementation Timeline

Milestone	Date	Status
MHRA consultation on future regulation	2022–2025	Completed
Consultation response published	July 2025	Published
CE-marking indefinite recognition consultation	Feb–Apr 2026	Closed, response pending
Draft Regulations published (WTO notification)	May 8, 2026	Published
Impact survey / call for evidence	May–Jun 2026	Open until June 19, 2026
Expected adoption	December 2026	Anticipated
Core provisions enter into force	June 2027	Anticipated
International Reliance Pathway operational	Mid-2028	Anticipated

What Manufacturers Should Do Now

1. Assess Your GB Market Access Strategy

Determine whether the International Reliance Pathway, CE marking, UKCA marking, or a combination best serves your product portfolio and commercial objectives. For manufacturers with FDA, Health Canada, or TGA approvals, the IRP may offer a faster, lower-cost route to the GB market starting in 2028 — but CE marking remains viable through at least June 2028 (2030 for MDR/IVDR-compliant devices) (Reed Smith).

2. Map Your IVD Portfolio

Review your IVD product portfolio against the proposed classification framework. Identify products likely to be reclassified upward and plan for new conformity assessment and QMS obligations. Early preparation will be essential given the expected volume of reclassification applications (PatientGuard).

3. Evaluate Northern Ireland Coverage

Confirm whether your regulatory strategy provides uninterrupted supply chain coverage across both GB and Northern Ireland. The diverging frameworks mean that a GB-only strategy may not cover Northern Ireland, and vice versa (Reed Smith).

4. Review UK Responsible Person Arrangements

Ensure your UKRP appointment is current, appropriately structured, and aligned with your broader distribution and commercial arrangements. The new regulations will likely increase the obligations on UKRPs (Reed Smith).

5. Prepare for PCCP Adoption

If you manufacture software or AI-enabled medical devices, begin developing PCCP documentation. Early adoption of PCCP frameworks — even before the regulations take effect — will position your organization to move quickly once the pathway becomes available (PatientGuard).

6. Submit Evidence to the MHRA

Respond to the MHRA's impact survey before the June 19, 2026 deadline. The survey seeks evidence on practical impact, including likely costs, benefits, and implementation considerations. Responses will inform the impact assessment for the proposed legislation (Latham & Watkins; BioSlice Blog).

How This Compares to EU Reforms

The timing of the UK draft regulations raises an important strategic question: will the UK and EU frameworks converge or diverge?

The European Commission published its own proposals to simplify aspects of the EU MDR and IVDR in late 2025. The UK draft regulations draw heavily on EU MDR/IVDR concepts for classification and essential requirements. But proposed EU amendments affecting classification, clinical evidence requirements, and post-market obligations could increase regulatory divergence if the final texts differ significantly (Hogan Lovells).

For manufacturers operating across both markets, the practical implication is clear: monitor both legislative processes in parallel, plan for two distinct regulatory submissions, and build flexibility into your regulatory strategy to accommodate potential divergence.

Sources

MHRA draft Medical Devices (Amendment) Regulations 2026, WTO notification portal, May 8, 2026
MHRA Government Response to consultation on routes to market and IVD devices, August 2025
Hogan Lovells, "UK Medical Devices Reform: MHRA Publishes Draft 2026 Regulations," June 2026
Latham & Watkins, "MHRA Publishes Draft Amendment to the UK Medical Devices Regulations," May 2026
BioSlice Blog (Arnold & Porter), "Draft UK Medical Device Amending Regulations: Key Proposals," May 2026
Hill Dickinson, "Update to the medical devices regulatory regime: key implications," June 2026
Reed Smith, "Britain to overhaul medical device market access rules," 2026
PatientGuard, "The MHRA 2026 Regulatory Roadmap Explained," 2026
LFH Regulatory, "International Recognition of Medical Devices: MHRA's Policy," 2026
GOV.UK, "Implementation of medical devices future regime," updated March 2026