The MHRA announced yesterday 19th September 2023 some fantastic news for medical device and diagnostics manufacturers; the IDAP program. The Innovative Devices Access Pathway (IDAP) program is designed to accelerate the development of medical devices and their integration that are both cost effective and safe for patients and end users.
This initiative is to bring new technologies and solutions to the National Health Service (NHS) to help with medical needs that are not currently being met. Not only that, but this would improve and increase patient access to innovative and transformative medical devices by providing an integrated and enhanced regulatory and access pathway to developers.
Successful applicants will receive non-financial support from a team of experts to develop a product specific Target Development Profile (TDP) roadmap. The TDP roadmap will define Regulatory and Access touchpoints across the product development, which could include;
– Quality management system (QMS) support
– System navigation
– Fast track clinical investigation
– Advice with scientific partners
– Product realisation and adoption from the HTA (Health technology assessments)
– NHS adoption
– Exceptional use authorisations from the MHRA where applicable
The IDAP is open to UK and international commercial and non-commercial developers with new health technology solutions and will choose 8 products to proceed. All size companies that fit the below applicant list can take part:
– Product must be a medical device and/or diagnostic tool
– Must have legal entity to market their product in the UK (IVDeology can help with becoming your UKRP – click here for more info)
– Early stage companies must demonstrate proof of concept evidenced by data from a near final prototype of the product
– Applicants must have the intention to market their product in the UK and obtain regulatory authorisation (IVDeology can support on this – click here)
– Applicants must have UK clinical investigations sites lined up
– Applicants must commit to working with IDAP to create target developments profiles
– The technologies must be able to demonstrate evidence of ISO13485 certification (IVDeology can support with QMS implementation – find out more here)
Pilot launch: 19th September
Pilot outcomes: December 2023
Profile engagements: Jan 2024
Follow the link here to start your application process – and we wish you all the best of luck!