International Recognition of Medical Devices: MHRA’s Policy Explained

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced a landmark policy proposal that will reshape how medical devices gain market access in Great Britain.

This Statement of Policy Intent on International Recognition, first published in February 2025 and updated in October 2025, sets out how the MHRA plans to recognise medical device approvals from other trusted regulators. The goal is clear: reduce duplication, accelerate access to safe and effective medical devices, and free regulatory resources to focus on innovation.

Why International Recognition Matters

Since leaving the EU, the UK has developed its own medical device regulatory framework. However, global manufacturers have long expressed concern about duplicated approvals, added cost, and slower patient access. The proposed international recognition framework aims to change this. It allows manufacturers whose devices are already approved by a Comparable Regulator Country (CRC) to apply for faster access to the Great Britain (GB) market.

Comparable Regulators include:

• Australia (Therapeutic Goods Administration – TGA)
  
• Canada (Health Canada)
  
• EU / EEA national competent authorities
  
• United States (Food and Drug Administration – FDA)
  

While the MHRA will consider approvals from these regulators, it retains the authority to reject evidence that is not robust or complete.

The Core Principles of the New Framework

The MHRA’s proposed framework introduces the concept of a “certificate of international recognition”, granting market access in Great Britain. However, this is not the same as UKCA marking or certification.

To qualify, a device must meet several key conditions.

Eligibility criteria:

• Compliance with the regulations of the Comparable Regulator Country.
  
• English-language labelling and packaging.
  
• Alignment with UK-specific technical standards (e.g. electrical safety, measurement units, hazardous substances).
  
• The device must have the same design, manufacturing process, and intended purpose as that approved in the CRC.
  
• A UK Responsible Person must be nominated, with their name and address displayed on the label.
  
• A Unique Device Identifier (UDI) compliant with UK regulations must be included.
  
• Compliance with UK post-market surveillance (PMS) requirements under the 2024 Amendment to UK MDR 2002.
  

These conditions ensure that only devices meeting international and domestic safety standards benefit from recognition.

Recognition vs Reliance: Two Routes to Market

The framework introduces both recognition and reliance pathways:

Recognition routes

These allow direct acceptance of approvals from comparable regulators, provided all eligibility conditions are met.

Reliance routes

Planned for introduction from 2027, reliance routes will allow the MHRA to rely on regulatory decisions from the U.S. FDA under frameworks such as:

• 510(k)
  
• De Novo
  
• Premarket Approval (PMA)
  

This means that devices cleared in the U.S. through these pathways could gain faster UK market access, reducing duplication for companies already operating in both markets.

Exclusions from the Framework

Not every device will qualify under the international recognition policy.
Certain higher-risk or complex products are excluded, including:

• In-house and custom-made devices.
  
• Software as a Medical Device (SaMD) and AI as a Medical Device (AIaMD)
  
• Devices that do not align with the UK definitions of intended purpose.
  
• Class IIb (non-well-established technology) implantables and Class III devices approved using predicate equivalence.
  
• Companion diagnostics relying on unlicensed UK medicinal products.
  
• Products excluded under Regulation 3 of the UK MDR 2002.
  

These exclusions reflect the government’s intention to maintain oversight of complex, high-risk, or emerging technologies.

Implementation Timeline and Transitional Measures

The international recognition framework is still in draft form and will be implemented alongside the future core UK medical device regulations, with a phased approach of implementation. 

• 2025: Testing and industry engagement.
  
• 2026: Legislative framework introduced.
  
• 2027: Reliance routes (including FDA recognition) become operational.

October 2025 Update: UK–US Regulatory Collaboration

In October 2025, the MHRA announced a formal collaboration with the U.S. FDA to align regulatory processes for medical devices.

The partnership aims to:

• Reduce regulatory duplication between the two agencies.
  
• Accelerate patient access to safe, innovative technologies.
  
• Develop shared standards for evaluating AI-based devices.
  

This collaboration would allow medical devices cleared under FDA frameworks, such as 510(k), De Novo, or Premarket Approval (PMA), to more easily gain UK regulatory approval. These reforms are expected to become law in 2026, with reliance routes active from 2027. 

Key Takeaways for Manufacturers

• The framework represents a pragmatic evolution of UK regulation, balancing safety with agility.
  
• Trusted international approvals can be leveraged for faster access to the UK market.
  
• Manufacturers must still comply with UK-specific labelling, PMS, and Responsible Person requirements.
  
• Software-based and high-risk devices will require additional scrutiny.
  
• Future reliance routes with the FDA will significantly reduce regulatory barriers for transatlantic market entry.

LFH supports MedTech companies in preparing for the UK’s evolving regulatory landscape. Our consultants help manufacturers navigate international recognition, FDA–MHRA alignment, and UKCA compliance, ensuring faster, safer, and more strategic routes to market.

FAQs – International Recognition of Medical Devices