The Medicines and Healthcare products Regulatory Agency (MHRA) has published proposed new pre-market regulatory requirements for medical devices and in vitro diagnostic (IVD) devices entering the Great Britain market.

The draft Medical Devices (Amendment) Regulations 2026 were published on the World Trade Organisation (WTO) notification portal on 8 May 2026, opening a formal period for feedback from stakeholders across the medtech sector.

BHTA members are encouraged to share their views on the proposed regulatory changes through the MHRA stakeholder impact survey. Member feedback will help inform the MHRA’s Impact Assessment and future implementation planning.

Key proposals within the draft regulations

According to the MHRA, the proposed changes are intended to introduce a more proportionate and patient-centred regulatory framework for medical devices and IVDs.

Key proposals include:

• Measures intended to give faster access to safe and innovative medical devices, while supporting economic growth and innovation across the UK medtech sector.
• A framework to enable faster access to devices already approved by regulators in Australia, Canada, and the United States.
• Mandatory use of unique device identifiers (UDI) to improve device traceability throughout the product lifecycle.
• Alignment of IVD classifications with International Medical Device Regulators Forum (IMDRF) standards.
• Alignment of essential device requirements with international best practice.
• Stronger requirements for technical documentation retention.
• New traceability and electronic prescription requirements for custom-made devices.
• Requirements for manufacturers to ensure claims about devices align with their intended purpose.

The MHRA states that the proposals are designed to support patient safety, improve transparency and strengthen access to innovative medical technologies across the UK.

The proposed reforms may be particularly relevant to members involved in manufacturing, importing, distributing, supplying, or servicing medical devices and IVDs. The survey is intended to gather evidence on the practical impacts of the proposals, including likely costs, benefits, and implementation considerations. As the MHRA develops its future regulatory framework, feedback from across the sector will play an important role in helping policymakers understand the potential operational, commercial, and compliance impacts of the proposed changes. Members responding to the survey are encouraged to provide specific examples relevant to their organisations where possible. All responses will be analysed in aggregate and anonymised.

How to respond

Read the WTO notification and draft Medical Devices (Amendment) Regulations 2026.

Complete the MHRA stakeholder impact survey.

The deadline for responses is 11:59pm (UK time) on Friday 19 June 2026.

The UK Government has announced enhanced collaboration between the Medicines and Healthcare products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA).

The collaboration is intended to accelerate innovation, strengthen patient safety, and reduce barriers to transatlantic market access for medical technologies and AI.

Key developments

The MHRA will deepen its regulatory collaboration with the FDA, with a shared ambition to advance alignment and reciprocity.

During the Advanced Medical Technology Association conference in San Diego, MHRA Chief Executive Lawrence Tallon highlighted the agencies’ commitment to accelerating joint initiatives and policy development, supported by strategic opportunities for cooperation.

The MHRA has launched the National Commission on the Regulation of AI in Healthcare, bringing together UK and international experts, including contributors from the United States. The commission will develop recommendations to support the safe and transparent use of AI-driven medical technologies and to contribute to international alignment.

The agency has also confirmed plans for new international reliance routes designed to improve international investment and increase UK access to medical devices that have already been approved by trusted regulators, including the FDA.

According to the announcement, the reliance framework is intended to include products cleared through the FDA’s 510(k), De Novo, and Premarket Approval (PMA) pathways.

What this means for BHTA members

For BHTA members operating in the UK and internationally, the planned international reliance routes are expected to facilitate faster UK market access for devices already approved by trusted regulators.

The strengthened collaboration between the MHRA and FDA, together with the establishment of the National Commission on the Regulation of AI in Healthcare, signals ongoing work to align approaches to regulating medical technologies and AI.

The medtech regulatory reforms in Great Britain are intended to enter legislation in 2026  and open new reliance routes from 2027.