Recently the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "The Innovative Devices Access Pathway (IDAP)" and guidance to "Notify the MHRA about a Clinical Investigation for a Medical Device".
Innovation Devices Access Pathway (IDAP) is a pilot program aimed at bringing new medical solutions to the National Health Service (NHS) to meet current medical needs.
By providing developers with an integrated and enhanced regulatory and access pathway, IDAP is facilitating and improving patient access to innovative and transformative medical devices. During the pilot, the major elements of the IDAP will be tested and feedback will be provided to aid in the development of the future IDAP.
IDAP partners will provide support at key stages of the product design and development process to successful applicants. To join the program, you need to complete the IDAP pilot application via GovForms.
The application will require completion of seven parts:
Part A: Eligibility
Part B: Company Information
Part C: Product Details
Part D: Regulation and Compliance
Part E: The IDAP Pilot Criteria
Part F: IDAP Support
Part G: Declaration & Submission
This guidance provides the details on How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
To know what is required by clinicians involved in the investigation, check out this guidance "Clinical Investigations of Medical Devices".For medical devices that are UKCA / CE / CE UKNI marked for the purpose under investigation, no notification to the MHRA is required.