On 31 July 2025, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) issued a statement of policy intent relating to a service to provide early access to the Great Britain market for innovative medical devices (“Early Access Service”). Although this statement is non-binding, it indicates further efforts by the MHRA to reduce unwarranted barriers to market entry, through faster, risk-proportionate, and predictable routes to regulatory approval – in line with Action 25 of the Life Sciences Sector Plan (published on 16 July 2025).
Purpose and Scope
The Early Access Service proposal follows the introduction of schemes such as the Innovative Devices Access Pathway (“IDAP”) (please see our prior blog post here), which the MHRA suggests demonstrated value in coordinated regulatory support and a targeted access pathway for medical devices.
The Early Access Service will be relevant to innovative devices that address clearly defined unmet clinical needs from the NHS or that have the potential to significantly improve patient outcomes. The MHRA’s statement of intent suggests that the initial focus will be specifically on diagnostic devices that address the most pressing needs and promote financial sustainability for the NHS. The MHRA has confirmed that the Early Access Service will be based on the Unmet Clinical Need Authorisation (“UCNA”) tool in the IDAP scheme.
For context, the IDAP scheme is an initiative that aims to improve access to innovative and transformative medical devices in the UK and satisfy unmet patient needs. Device manufacturers selected to participate in the IDAP scheme receive regulatory and market access advice and support at key stages of the development process from “IDAP partners” (including regulatory and market access bodies such as the MHRA, the National Institute for Health and Care Excellence (“NICE”) and the Department of Health and Social Care).
One of IDAP’s features is to provide an opportunity for the MHRA to assess whether a device is eligible for exceptional use authorisation and, if so, issue a UCNA. The IDAP UCNA is granted by the MHRA for a specified period and exempts the manufacturer from certain regulatory requirements. The MHRA is empowered to authorise the placing of non-UKCA or non-CE marked devices on the Great Britain market under Regulations 12(5), 26(3) and 39(2) of the UK Medical Devices Regulations 2002 “in the interests of the protection of health.”
The Early Access Service will exist alongside and complement these measures aimed at streamlining regulatory assessments in a risk-proportionate manner to reduce time to patient access. It appears that the Early Access Service is intended to provide a broad “business-as-usual” pathway, distinct from the more bespoke IDAP scheme, which has limited capacity and application windows.
In practice, the Early Access Service will provide conditional access to the Great Britain market for devices that do not yet meet all the applicable regulatory requirements (such as UKCA/CE marking), but are deemed to meet the criteria above. The Early Access Service will also offer a bridging scheme to maintain patient access to such devices in cases where clinical investigation has ended but the device manufacturer is still awaiting full regulatory approval.
Devices that successfully access the market through the Early Access Service will be granted a time-limited authorisation with specific conditions relating to ongoing safety monitoring and data collection. Notably, during this limited period of conditional authorisation, the manufacturer of the device will be expected to demonstrate continued progress towards obtaining full regulatory approval for the device.
Northern Ireland
The MHRA’s statement also addresses the application of the Early Access Service to Northern Ireland – where devices must comply with the EU Medical Devices Regulation 2017/745 or EU In Vitro Medical Devices Regulation 2017/746, as applicable, by virtue of the Northern Ireland Protocol. The MHRA states that it will carefully consider the interaction of the Early Access Service with arrangements that apply in Northern Ireland, but notes that it has the power to exceptionally authorise devices for the Northern Ireland market where there is a public health need.
Next Steps
The MHRA intends to develop internal capacity to deliver the Early Access Service while engaging with key stakeholders to prepare the scheme for implementation.
The statement of policy intent provides limited further practical detail at this stage, but Covington will continue to follow developments and provide updates.
Separately, the MHRA is in the process of introducing broader reforms to the UK medical devices regulatory landscape (please see our prior blog post here), including an international reliance procedure for medical devices approved by trusted regulators in other jurisdictions.
If you would like to discuss the latest medical device developments in the UK (or EU) and what they may mean for your company’s operations, please contact: Sarah Cowlishaw or Dan Spivey.