Clinical data on high risk medical devices should be made publicly available

Doctors and patients should have access to information on clinical trial data used to approve high risk medical devices so that they can make informed decisions about the devices they use, a WHO agency says.

In a report the Belgian Health Care Knowledge Centre recommends that the EU Medical Devices Directive should be adapted to require all manufactures of high risk medical devices to carry out “high quality randomised trials . . . with clinically relevant endpoints.”

The Belgian Health Care Knowledge Centre is part of WHO’s Health Evidence Network, which promotes the use of research evidence in health policy and health technology assessment. Its report places more emphasis on testing devices for their clinical effectiveness rather than the current focus on assessing …