MHRA MD Guidance: Innovative Devices Access Pathway (IDAP) & How to Notify Clinical Investigation

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".

Guidance: The Innovative Devices Access Pathway (IDAP)

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

To learn more about the Eligibility criteria, How to Apply, and know about the IDAP Pilot criteria click this LINK and IDAP pilot application guidance.

Guidance: Notify the MHRA about a Clinical Investigation for a Medical Device

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.