Last updated: 20 June 2025
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The UK launched the regulatory Innovative Devices Access Pathway (IDAP) in September 2023.
About the Innovative Devices Access Pathway (IDAP)
The aim of IDAP is to enable and improve patient access to innovative and transformative medical devices by providing an integrated and enhanced regulatory and access pathway to developers.
What is the ambition of this new pathway?
The ambition of this new pathway is to support the rapid development of innovative technologies that can be introduced into the National Health Service (NHS) to address unmet clinical needs for patients and healthcare professionals at the earliest opportunity, without compromising on standards of safety, quality, and effectiveness.
The aim is to help take uncertainty out of the route to access, bringing innovative technologies to patients that can transform health outcomes.
What does the pathway build upon?
The pathway builds on the government’s intention to develop an end-to-end pathway for innovation as set out in the Medical Technology Strategy published on 3 February 2023 and delivers on the ambitions set out in the Government’s Life Sciences Vision
Who are the IDAP partners?
The IDAP partners comprise of the following organisations:
- Department of Health and Social Care (DHSC)
- Health Technology Wales (HTW)
- Medicines and Healthcare products Regulatory Agency (MHRA)
- National Health Service England (NHSE)
- National Institute for Health and Care Excellence (NICE)
- Office of Life Sciences (OLS)
- Scottish Health Technologies Group (SHTG)
About the IDAP Pilot
The Innovative Devices Access Pathway (IDAP) pilot is an initiative to bring new technologies and solutions to the UK National Health Service (NHS) to help with medical needs that are not currently being met.
Following an announcement in May 2023, the pilot phase of the Innovative Devices Access Pathway (IDAP) was launched on 19 September 2023.
- The aim of the pilot is to test the main elements of the pathway and to provide informative learning and feedback that helps to build the future IDAP.
- Innovators were invited to submit Expressions of Interest for access into the pathway.
- On 1 December 2023, the MHRA confirmed on its website.
- You can read more about the pilot here.
How will the IDAP partners use the lessons learnt from the pilot?
Once up-and-running, the IDAP partners will use the lessons learned from the pilot to help develop the future IDAP pathway, creating an end-to-end visible framework that supports innovators generate the evidence they need to achieve regulatory approval, heath technology assessment decisions, and patient access in the NHS.
What is IDAP expected to demonstrate?
According to Dr Marc Bailey, MHRA Chief Science and Innovation Officer:
“The new IDAP will demonstrate how the UK regulator, health technology assessment and the healthcare system are working together to deliver safe, effective, and earlier innovative medical products to patients, establishing the UK as a centre for medical innovation”
Source: MHRA
The IDAP Unmet Clinical Need Authorisation (UCNA)
What does the UCNA allow?
An Innovative Devices Access Pathway (IDAP) Unmet Clinical Need Authorisation (UCNA) allows non-UKCA or non-CE certified medical devices to be placed on the Great Britain (GB) market in the interest of the protection of public health.
What principle is the UCNA based upon, which products is it applicable to and what is its period of grant?
The IDAP UCNA, which is based upon the principle of the MHRA Exceptional Use Authorisation, is granted by the MHRA for a specified period and exempts the manufacturer from certain regulatory requirements.
- The MHRA reviews each UCNA application individually. The UCNA is subject to specific conditions and requires that the manufacturer demonstrate ongoing progress towards full conformity with the applicable regulations.
- The UCNA is not an alternative route to the UK market and is only applicable to products selected for the IDAP pilot.
Under what circumstances can the UCNA be granted?
This authorisation can only be granted in certain situations, where the MHRA considers that the UCNA criteria are met and specifically that:
- the technology addresses a critical unmet clinical need
- there is sufficient data to show that the product is safe and potentially effective
- there is evidence that the manufacturer is working towards regulatory approval or certification
To which patients does a UCNA allow access?
The UCNA permits controlled access to a specified patient population and requires that manufacturer report safety and performance data to the MHRA in line with the authorisation conditions.
- For the eight IDAP pilot technologies (listed in this post), manufacturers were able to request to supply their medical device prior to UKCA or CE marking as an exceptional use because there were limitations to other existing treatments available.
- The Unmet Clinical Need Authorisations were exclusively issued directly to the manufacturer of the medical device and only applied to devices supplied to the GB market.
- There was one UCNA issued during the IDAP pilot.
Source: MHRA