Reform of medical device approval process not straight-forward

Across Europe, health systems are facing similar challenges such as rising costs and rapid development and pace of change of health technologies.

The latter exerts pressure on health systems to fund technologies while striving for value for money, as well as ensuring patient safety. As a result, health technologies (including pharmaceutical products, medical devices, etc.) need to be examined for efficacy and effectiveness (including cost-effectiveness) to get market access and reimbursement approval.

Over the past two decades, regulations, license approval processes, and methods for establishing cost-effectiveness, to inform adoption and reimbursement decisions, have developed and are now well-established for capital projects and pharmaceutical products. However, for medical devices, it is only recently coming to the attention of European decision-makers, such as the European Parliament.