New regulatory pathway set to support safe patient access to innovative medtech
The Medicines and Healthcare products Regulatory Agency (MHRA) is set to launch the Innovative Devices Access Pathway (IDAP) later in 2023.
IDAP is designed to facilitate the development of innovative technologies, including assistive technologies, by providing innovators and manufacturers with a multi-partner support service including targeted scientific advice that brings new products to patients sooner.
It will be operated by the MHRA, the National Institute for Health and Care Excellence (NICE), Health Technology Wales (HTW), and Scottish Health Technology Group (SHTG).
The ambition of this new programme is to bring innovative technologies and solutions to the forefront of the 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.
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.”
Now, 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. This can be done by sending 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 Susan Myles, Director of Health Technology Wales, commented: “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.”
Recently, the UK Government announced multi-million-pound funding for medtech sector. Find out more about this investment here.