Report pushes dialogue on clinical evidence for medical devices

According to a report by The Dutch Royal Academy of Sciences, in its Evalulation of New Technology in Health Care report, medical devices should not be treated in the same way as pharmaceuticals and a one-size-fits-all approach should not be applied to them.

The independent body which advises the Dutch government highlighted that at present EU legislation doesn’t provide clear guidance on how to design research/clinical investigations on devices. It suggests that three main approaches should be used to generate clinical evidence.

These are: Studies providing direct evidence of the benefits or added benefits of a device use for health or health care; studies providing indirect evidence of the benefits or added benefits of a device use for health or health care, using a quantitative linked-evidence approach and studies providing indirect evidence of the benefits or added benefits of a device use for health or health care, using a qualitative linked-evidence approach