Ensuring timely and affordable access to medical devices

Medical devices cover a wide range of products of varying complexity and clinical risk. Practitioners’ aptitude in using medical devices in clinical settings also varies. Regulation, coverage and funding of devices thus present a considerable challenge for policy makers who need to balance the often competing objectives of safety, effectiveness, equity and timely access. Regulatory requirements for medical devices were historically less stringent than those for pharmaceutical products. This chapter examines the current state of play for medical device regulation (determining the safety, performance and effectiveness for initial market authorisation and post-market evaluation) and coverage and funding (determining their inclusion in payment schedules and the reimbursement level for their use). It provides a series of recommendations to improve these aspects of regulatory regimes in OECD countries and other health care systems. The chapter also describes the institutional requirements and policy framework needed to enable sound regulatory, coverage and funding decisions. These include governance, information infrastructure and stakeholder involvement.