Incentivizing research into the effectiveness of medical devices

Excerpt

Medical devices (MDs) often obtain market authorization with much less clinical evidence than other health technologies, especially pharmaceuticals. This is due to a number of reasons. First, in contrast to pharmaceuticals, there is no legal requirement to conduct adequately controlled clinical studies, other than for ‘high-risk’ devices in some jurisdictions. In the US for example, high-risk devices and innovative lower-risk devices are required to demonstrate ‘reasonable assurance of safety and effectiveness’, which may imply clinical evidence based on randomized studies in many instances. In contrast, in the EU the requirement is to demonstrate adequate performance and safety, which can often be achieved by conducting observational studies such as registries [1, 2]. …