On 31 July 2025, the UK government published a statement of policy intent, setting out its initial thinking on an Early Access Service (EAS) for innovative medical devices. The intention is for this to first focus on innovative diagnostic devices, particularly those supporting the NHS's most urgent needs and financial sustainability in the NHS. It is hoped this will lead to quick market access of such devices, by addressing challenges associated with generating sufficient evidence to obtain regulatory approval.
The aim is to introduce controlled and time-limited market access for medical devices prior to UKCA marking where the device addresses an unmet clinical need or has the potential to significantly improve patient outcomes. This will help innovators collate real world evidence on the use of their device and also support access for patients. The scheme will do this through the granting of "conditional authorisations" using the existing powers in the Medical Devices Regulations 2002 for the MHRA to exempt certain devices from needing to meet full regulatory requirements. The "approval" will however include specific conditions to be met, such as on safety monitoring and data collection. Innovators will also be expected to progress towards conformity assessment and full regulatory approval.
Through the EAS, innovators will receive structured regulatory support, including regulatory advice through the establishment of an advisory service, and help with planning their regulatory pathway. The MHRA will link the EAS with other government initiatives designed to improve MedTech adoption in the NHS.
The proposal has been developed from the lessons learnt through the Unmet Clinical Need Authorisation (UCNA) tool piloted in the Innovative Devices Access Pathway (IDAP), discussed in our previous blog post. The EAS will enable the UCNA tool to be available to innovators outside of innovative regulatory pathways such as IDAP, and will be separate from the existing Exceptional Use Authorisation pathway, which is not for innovation purposes, but used for the supply of devices in the interests of protecting public health. It is also likely, given the clear parallels in approach, that as the EAS is developed, consideration will be given to the operation of and recent amendments to the Early Access to Medicines Scheme, which allows early patient access to promising, unlicensed medicines for serious or life-threatening conditions with a clear unmet medical need.
The MHRA states it will now engage with stakeholders to refine and implement the EAS for innovative devices. Additional guidance, setting out eligibility criteria, the application process and evidence standards, is expected in due course.
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