Last updated: 14 February 2024
See updates at the end of this post.
Following an announcement in May 2023, the pilot phase of the Innovative Devices Access Pathway (IDAP) was launched on 19 September 2023.
Innovators are invited to submit Expressions of Interest for access into the pathway.
On 1 December 2023, the MHRA confirmed on its website that the pilot is now closed
About the IDAP pathway
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.
What are the aims of IDAP and the pilot?
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.
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.
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.
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)
Who can apply for entry to the programme?
Entry to the IDAP is open to both commercial and non-commercial innovators of medical technology in the UK and abroad.
Who/what is out of scope for the programme?
- Drug medical device combination products
- Legal entities headquartered or operating out of jurisdictions that are the subject of UK Government sanctions. View the sanctions list.
What type of support could be offered to successful applicants?
Throughout the pathway, successful applicants will receive targeted non-financial support from a team of experts (from the IDAP partners) to develop a product specific Target Development Profile (TDP) roadmap. The TDP roadmap will define Regulatory and Access touchpoints across the product development, which could include;
- quality management system support
- system navigation advice
- a fast-tracked 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.
What are the eligibility requirements for entry to the IDAP pilot programme?
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 the following criteria, addressing a significant unmet clinical need as defined in the programme.
- The product must be a medical device.
- The lead applicant must be a legal entity with the rights to market their health product in the UK.
- For early-stage health technologies, organisations must demonstrate a proof of concept evidenced by data from a near final prototype.
- The applicant must be intending to market the health product in the UK and intend to obtain regulatory authorisation.
- The applicant must have UK clinical investigation sites lined up.
- The applicant must commit to working with the IDAP partners to create a Target Development Profile.
- Technologies must be able to demonstrate evidence of ISO 13485 certification or equivalent.
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.
What are the IDAP pilot criteria?
The IDAP pilot criteria are as follows:
Criterion one: The condition is life-threatening or seriously debilitating and there is a significant patient need.
Criterion two: The product is innovative and transformative.
Criterion three: The product will provide system wide benefit.
Criterion four: the technology clearly helps to address one of the following Life Sciences Vision’s Healthcare Missions:
More information is available on each of the above criteria, on this page.
What are the key dates for submissions for the pilot phase?
- Pilot live for applications 25 September 2023 00:00 BST
- Submission deadline 29 October 2023 23:59 BST
- IDAP pilot notifications from December 2023
- Target Development Profile engagements from January 2024
On 1 December 2023, the MHRA confirmed on its website that the pilot is now closed.
How can you apply for the pilot?
To join the program, you need to complete the IDAP pilot application via GovForms.
The form will launch week commencing 25 September 2023. Until then, you can view a template of what the web form will look like, to allow you to start preparing your evidence in advance.
The application will require completion of seven parts:
- Part A: Eligibility
- Part B: Company Information
- Part C: Product Details
- Part D: Regulation and Compliance
- Part E: The IDAP Pilot Criteria
- Part F: IDAP Support
- Part G: Declaration & Submission
Upon completion of the web form you will receive confirmation of the submission and a unique IDAP pilot reference number. Please quote this number in any enquiries.
Is there a fee for application or participation in the IDAP pilot?
No, there is no fee for application or participation in the IDAP pilot.
Where can you find more information on the IDAP pilot phase and detailed guidance on the IDAP pilot application?
More information on the IDAP pilot phase is available here.
Further detailed guidance on the IDAP pilot application is available here and it includes an FAQ.
Post pilot closure
The eight successful applicants whose products have been selected for the pilot will receive support at key stages of their product development journey from the IDAP partners.
The eight successful applications are as follows:
- Blood-based biomarker test for Alzheimer’s Disease: Developed by Roche Diagnostics Ltd.
- Algorithm-based infection predictor: Developed by Presymptom Health Ltd.
- Liver cancer treatment using focused ultrasound: Developed by HistoSonics Inc.
- Artificial intelligence to predict at risk COPD patients: Developed by Lenus Health Ltd
- Multiple Sclerosis fatigue app: Developed by Avegen Ltd.
- Portable diagnostic device for stroke identification: Developed by Upfront Diagnostics Ltd
- Self-test diagnostic device for neutropenia: Developed by 52 North Health
- Artificial intelligence to predict at risk COPD patients: Developed by Lenus Health Ltd
Next steps for the successful medical device products: Target Development Profile meetings
Target Development Profile (TDP) meetings between the product developers and IDAP partners will take place early in the pilot. Patient and public involvement at these meetings will be determined on a case-by-case basis.
The TDP defines a pathway for the selected manufacturers that enables direct interaction with partners in an innovative approach to support the safe, timely and efficient generation of evidence to underpin both regulatory approval and Health Technology Assessment (HTA) of innovative medical devices.
You can read more about them on this page.
Source: MHRA
Updates
| Date | Update(s) |
|---|---|
| 14 Feb 2024 | Added new section Post Pilot closure and sub section Next steps for the successful medical device products: Target Development Profile meetings |
| 1 Dec 2023 | Section What are the key dates for submissions for the pilot phase? updated to state the the pilot is now closed. |
| 27 Oct 2023 | 1) Section entitled What are the key dates for submissions for the pilot phase? updated in line with the MHRA website. 2) Section entitled Where can you find more information on the IDAP pilot phase and detailed guidance on the IDAP pilot application? updated to include the point that an FAQ is included in the detailed guidance. |