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The pilot phase of the Innovative Devices Access Pathway launched in the UK
On September 19, 2023, the Innovative Devices Access Pathway (IDAP) pilot was launched in the UK. IDAP aims to enable and improve patient access to innovative and transformative medical devices by providing developers with an integrated and enhanced regulatory and access pathway. The pilot aims to test the pathway's main elements and provide informative learning and feedback that helps build the future IDAP.
The IDAP is managed by the following partner organizations: 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), and Scottish Health Technologies Group (SHTG).
The application window is open from September 25 to October 29, 2023, to UK and international commercial and non-commercial developers with new health technology solutions.
The eligibility and innovation criteria must be met for successful entry to the pilot.
Key eligibility criteria include the following:
- 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, organizations must demonstrate a proof of concept evidenced by data from a near-final prototype;
- The applicant must intend to market the health product in the UK and intend to obtain regulatory authorization;
- The applicant must have UK clinical investigation sites lined up.
Four IDAP Pilot criteria must be met:
- The condition is life-threatening or seriously debilitating, and there is a significant patient need;
- The product is innovative and transformative;
- The product will provide system-wide benefits;
- The technology clearly helps to address one of the Life Sciences Vision's Healthcare Missions.
Successful applicants will receive non-financial support from a team of experts to develop a product-specific Target Development Profile (TDP) roadmap. The TDP roadmap will define Regulatory and Access touchpoints across the product development.
See the full details here.
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