1. IDAP Pilot Program Guide
Welcome to another edition of the Deviceology blog. Today, we explore the Innovative Devices Access Pathway (IDAP), a groundbreaking initiative by the UK government. This pilot program, launched on 19th September 2023 and set to conclude on 29th October 2023, aims to revolutionise the way medical devices are developed and integrated into the UK healthcare system. This blog post will serve as a comprehensive guide to understanding the IDAP pilot and how Deviceology Ltd can assist you in this journey.
2. Objectives of IDAP
The IDAP pilot is not just another program; it’s a strategic move to foster innovation in medical technology. It serves as a testing ground for the main components of the pathway, providing actionable insights and feedback. The ultimate goal is to streamline the development and approval processes, thereby accelerating the time-to-market for innovative medical devices.
3. Consortium of Partners
The IDAP is a collaborative venture involving key organisations in healthcare and technology:
– Health Technology Wales (HTW): Focuses on health technology assessment.
– Medicines and Healthcare products Regulatory Agency (MHRA): Responsible for ensuring the safety and efficacy of medical devices.
– National Health Service England (NHSE): The public health service provider in England.
– National Institute for Health and Care (NICE): Provides evidence-based guidance and advice.
– Scottish Health Technologies Group (SHTG): Evaluates health technologies in Scotland.
4. Eligibility Criteria
The IDAP pilot is inclusive, welcoming participants from around the globe, except for those from sanctioned countries. The program is particularly interested in established products or solutions that are beyond the idea stage. This aligns with international standards such as ISO 13485, which sets the quality management system requirements for medical devices.
5. Funding and Support
The UK government has allocated £10 million to support this pilot program. This financial backing aims to expedite the development and integration of advanced medical technologies into the UK healthcare system.
6. Application Process
The application process is straightforward but requires attention to detail. Applicants must complete the IDAP pilot application via GovForms in a single session. Upon successful submission, a unique IDAP pilot reference number is generated, which should be used for all future communications regarding the application.
7. IDAP Application Assistance
Deviceology Ltd offers end-to-end support for organisations worldwide looking to apply for the IDAP pilot. Our services include application assistance, regulatory compliance guidance, and market access strategy. We extend our expertise to help you gain access to other major medical device markets like the EU and the US. For customised assistance, contact us at info@deviceology.net
8. Benefits of Participation
Participation in the IDAP pilot comes with a plethora of benefits. Successful applicants will have access to a suite of tools and resources, including testing and regulation support from MHRA and feasibility studies from NICE. These benefits are designed to facilitate the device’s seamless integration into the UK public health system, starting from January 2024.
9. Evaluation and Selection
A panel of experts from various disciplines will evaluate all applications. The assessment criteria focus on the potential impact and benefits that the products could gain from the pilot program’s expertise and tools.
10. Intellectual Property and Data Protection
Rest assured, the intellectual property rights of your products are secure. All information shared during the application process is confidential and protected under UK data protection legislation, in compliance with ISO/IEC 27001 standards for information security management.
11. Fees and Market Access
There is no UK Government application or participation fee for the IDAP pilot. Moreover, the MHRA has the authority to grant exceptional authorisations for medical devices in both the GB and NI markets, thereby broadening your market access opportunities.
12. Conclusion
The IDAP pilot program is a monumental step towards fostering innovation in medical technology. With its well-defined objectives, collaborative approach, and robust support system, it offers a unique opportunity for medical device companies. Deviceology Ltd is committed to assisting eligible organisations and individuals in navigating this complex yet rewarding pathway.
3. Contact Information
For more details about the IDAP pilot, you can reach out to IDAPEnquiries@mhra.gov.uk. For assistance with your application and market access strategy, contact Deviceology Ltd at info@deviceology.net or visit www.deviceology.info