GRS News

The Innovative Devices Access Pathway (IDAP) is a pilot initiative aimed at bringing new technologies and solutions to the National Health Service (NHS) to address unmet medical needs. The goal of IDAP is to improve patient access to innovative and transformative medical devices by providing an integrated and enhanced regulatory and access pathway to developers.

The pilot phase of IDAP is designed to test the main elements of the pathway and provide informative learning and feedback that helps build the future IDAP. The IDAP is open to UK and international commercial and non-commercial developers with new health technology solutions.

Successful applicants will receive support at key stages of their product design and development process from the IDAP partners, which include the 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 support provided includes developing a product-specific Target Development Profile (TDP) roadmap, 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 realization and adoption, safe-harbour meetings to discuss NHS adoption, and exceptional use authorization granted by the MHRA, provided necessary safety standards are met.

To be eligible for the IDAP pilot, 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, and for early-stage health technologies, organizations must demonstrate a proof of concept evidenced by data from a near final prototype.

Find more details regarding the program by visiting - https://www.gov.uk/government/publications/the-innovative-devices-access-pathway-idap

Remember, The IDAP pilot will launch 19 September 2023 and run until 29 October 2023.

While this program will help the applicants with a Roadmap, Experts at GRS are here to get things done!

We can support you with

• IDAP Application Process
• Regulatory Compliance Assessment
• Regulatory Affairs Representation
• Performing Regulatory Aspects of Project Management
• Creating, Implementing and Maintaining a Risk Management Plan
• Commercialisation support
• Implementing a Quality Management System
• Market Access Strategy
• Continual Updates and Advisory Services

Connect with our experts by sending an email to grs@globalregulatoryservices.com

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