Evidence gaps for drugs and medical devices at market entry in Europe and potential solutions

KCE Reports 347C (2021)

To obtain marketing authorisation for the European market, any new product must provide evidence of its quality, safety and efficacy. For high-risk medical devices (e.g. implants), the requirements are less strict. But, for health insurance companies, doctors and patients, what really matters is the value of the new product compared with the existing treatments. The problem is that comparative studies – which measure significant parameters for patients – are not compulsory for obtaining a marketing authorisation.
The main recommendation from KCE is that pharmaceutical companies and medical device manufacturers should not only design their clinical studies to meet the current requirements for accessing the European market, but that they should also, from the outset, collect comparative data to allow them to meet the demands of national health insurance bodies, doctors and patients. The KCE study is very timely, given the recent changes in the various European regulations on medicines and medical devices.