Medicines Healthcare Products Regulatory Agency
The IDAP, supported by 10 million of Government funding, has the potential to expedite UK patient access to innovative technologies by providing innovators and manufacturers with multi-partner support and targeted scientific advice.
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 pathway builds on the governments 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 Governments Life Sciences Vision.
Following announcement of the IDAP on 25 May 2023, today the government launched the pilot phase and innovators are invited to submit Expressions of Interest for access into the pathway.
Throughout the pathway the partners will offer targeted support to successful applicants which may include:
- The development of a targeted product roadmap
- System navigation advice
- A priority clinical investigation
- Joint scientific advice with partners
- Support with Health Technology Assessments (HTA) for product realisation and adoption
- Safe-harbour meetings to discuss NHS adoption
- Exceptional use authorisation granted by the MHRA, provided necessary safety standards are met
David Lawson, Director of Medical Technology at the Department of Health and Social Care, said:
Todays launch marks an important step forward in the implementation of the Medical Technology Strategy published in February this year. It signals our commitment to move towards a rules-based pathway which will ensure the adoption of specialty innovative medical technology into the NHS, helping to benefit patient outcomes. The IDAP showcases our internationally respected regulatory and guidance bodies and the tailored support on offer for technologies that meet the specific needs of the NHS.
Dr Susan Myles, Director of Health Technology Wales, said:
We are proud to be a part of this ground-breaking project which aims to speed up access to innovative technologies for patients across the country.
We would urge innovators to consider applying for this exciting opportunity. And we look forward to supporting the successful applicants on their journey through the pathway.
Dr Marc Bailey, MHRA Chief Science and Innovation Officer, said:
The IDAP launch marks an exciting step in accelerating the delivery of cutting-edge medical technologies safely to patients across the UK. The insights gained during the pilot phase will be crucial in shaping the future direction of this new pathway.
We encourage medical technology innovators in the UK and abroad to submit their applications and benefit from this combined support service. By working together, we can fast-track access to the most advanced technologies for those in urgent need.
Jeanette Kusel, Director of NICE Scientific Advice, said:
At NICE were committed to focussing on what matters most to patients and healthcare providers. This pathway will offer companies the direction they need to properly demonstrate the value of innovations that have the potential to address unmet need in the system. The opportunity for developers of game changing health technologies to access expertise from both regulators and health technology appraisers is a unique aspect of IDAP.
Ed Clifton, Unit Head of the Scottish Health Technologies Group (SHTG) which is part of Healthcare Improvement Scotland, said:
IDAP offers a fantastic opportunity to transform access to medical technologies across the UK for the benefit of our patients, the delivery of our health and care services, and our life sciences sector. The collaboration between MHRA and HTA partners (like SHTG) means that IDAP is uniquely placed to deliver the right regulatory and evidence support, at the right time, for all successful applicants on the pathway.
Submissions for the pilot phase open 19 September 2023 and close 29 October 2023.
To be eligible for the programme, applicants must submit devices that do not have a CE mark, UK CA mark or regulatory approval. Products must meet criteria, addressing a significant unmet clinical need as defined in the programme. Applicants will need to demonstrate a proof of concept evidenced by data to a near-final prototype and have already sought clinical input from at least one UK health organisation or medical charity.
Entry to the IDAP is open to both commercial and non-commercial innovators of medical technology in the UK and abroad.
Further information about the IDAP and how to apply:
The Innovative Devices Access Pathway (IDAP)
This follows a previous announcement from the Partners in May 2023 encouraging innovators of medical technology to register their interest in the pathway ahead of the pilot launch.
Find out more
The Innovative Devices Access Pathway (IDAP)
Notes to editors
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