New regulatory pathway set to support safe patient access to innovative medical technologies
The Innovative Devices Access Pathway (IDAP), set for launch later in 2023, will be operated by the Medicines and Healthcare products Regulatory Agency (MHRA), the National Institute for Health and Care Excellence (NICE), Health Technology Wales (HTW) and Scottish Health Technology Group (SHTG).
Plans are advancing for a new regulatory pathway that facilitates the development of innovative technologies, by providing innovators and manufacturers with a multi-partner support service including targeted scientific advice that brings new products to patients sooner.
Set for launch later in 2023, the IDAP will be run by the MHRA, NICE, and other partners, including the devolved administrations.
The ambition of this new programme is to bring innovative technologies and solutions to the forefront of the National Health Service (NHS), through a new, integrated support service for developers that will include enhanced opportunities for engagement.
The aim is to help take uncertainty out of the route to access, bringing innovative technologies to patients that can transform health outcomes.
From today, innovators of medical technology (commercial or non-commercial, UK based or international) that addresses clinical needs are being encouraged to register for further information ahead of a planned 2023 pilot launch. Please send an email with details to IDAPEnquiries@mhra.gov.uk.
Once up-and-running, the IDAP partners will use the lessons learned from the pilot to help develop the future IDAP pathway, creating an end-to-end visible framework that supports innovators generate the evidence they need to achieve regulatory approval, heath technology assessment decisions, and patient access in the NHS.
Dr Marc Bailey, MHRA Chief Science and Innovation Officer, said:
“The new IDAP will demonstrate how the UK regulator, health technology assessment and the healthcare system are working together to deliver safe, effective, and earlier innovative medical products to patients, establishing the UK as a centre for medical innovation.”
“We would welcome early interest from potential applicants, so we can keep them updated as this key partnership and pathway develop.”
Mark Chapman, Interim Director of medical technology and digital evaluations at NICE, said:
“We look forward to working with industry to continue the acceleration of our evaluations and with the MHRA to align our work for the benefit of patients.”
Dr Susan Myles, Director of Health Technology Wales, said:
“Now more than ever innovative solutions are needed to address healthcare challenges. We look forward to working in partnership with organisations from across the UK to ensure that IDAP helps to accelerate the development and adoption of these technologies for the NHS.”
Further information:
For further information on the IDAP, please visit the IDAP homepage.
For any further queries, please email IDAPEnquiries@mhra.gov.uk, providing your name, organisation name, and email address.
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks. The MHRA is an executive agency of the Department of Health and Social Care.