ARTICLE SUMMARY:
The UK launches an accelerated market access pilot pathway. Excerpted from Pathways Picks September 20: A Busy Week in Medtech Policymaking.
Seven UK agencies launched a pilot for a new device pathway September 19 designed to accelerate select “innovative and transformative” devices through clinical development, regulatory approval, health technology assessment, and National Health Service adoption. Specifically, devices selected to participate in the Innovative Device Access Pathway (IDAP) pilot can benefit from a fast-tracked clinical investigation and approval by the Medicines and Healthcare products Regulation Agency (MHRA), joint scientific advice and HTA support from multiple agencies, early meetings with NHS stakeholders, and overall system navigation and quality management support. Companies planning to market a new device in the UK can apply to participate in the IDAP pilot from September 25 through October 29. Products need to meet a series of eligibility criteria and, in particular, must address an unmet need for a “life-threatening or seriously debilitating” condition, must be truly novel and potentially transformative with a system-wide benefit, and must target one of six UK health priorities. In addition to MHRA, IDAP partner agencies include NHS England, the Department of Health and Social Care, the Office of Life Sciences, the National Institute for Health and Care Excellence, and HTA arms from Wales and Scotland.