The scheme is currently in a pilot phase and is open to manufacturers seeking to develop and commercialise an innovative device in the UK. The application period runs from 25th September until 29th October 2023 and will be limited to up to eight devices. Successful applicants, who meet the eligibility and innovation criteria, will receive advice and support at important stages of their development process from key organisations, such as the Medicines and Healthcare products Regulatory Agency (MHRA), National Institute for Health and Care Excellence (NICE) and the Department of Health and Social Care (DHSC).

Benefits of Applying for the IDAP

Although this is a pilot scheme, designed to test the main elements of the pathway and hone its structure, what is being proposed as a pathway is a welcome initiative, promising “an integrated and enhanced regulatory and access pathway”, with support at key stages in the development process, aimed at streamlining market approval and market access processes for innovative medical devices, thus reducing the time to market and assisting in securing reimbursement.

How to Apply for the IDAP

Applicants will need to meet both eligibility and IDAP pilot criteria to be successful. The eligibility criteria are set out in the IDAP Pilot Phase Guidance and it should be noted that the device cannot be a medical device combination product. The four IDAP Pilot criteria are set out below and are broadly consistent with the ILAP criteria:

  • Criterion 1: the intended purpose of the device should be for a condition that is life-threatening or seriously debilitating and where there is a significant patient need;
  • Criterion 2: the product must be innovative and transformative;
  • Criterion 3: the product must provide system wide benefit; and
  • Criterion 4: the technology clearly helps to address one of the “Life Sciences Vision’s Healthcare Missions.” These Missions cover priority areas such as neurodegeneration/dementia, early diagnosis/treatment, treatment and prevention of cardiovascular diseases, reducing mortality and morbidity from respiratory diseases, addressing the underlying biology of ageing and increased understanding of mental health conditions.

To join the Pilot applicants must submit a completed application form before the deadline of 29th October 2023. Further guidance on the application process can be accessed here. The outcomes of the pilot application process will be communicated in December 2023.

Finally …

Whilst this is a pilot scheme, we think the proposed IDAP offers an important new pathway for the most promising medical devices, with the potential for reducing time to market and helping to secure reimbursement. Medical device manufactures interested in applying are urged to do so without delay and before the application deadline closes on 29th October.

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