The need for transparency of clinical evidence for medical devices in Europe

The Lancet

11 August 2018 - To use medical devices rationally, health-care professionals must base their choices of which devices to recommend for individual patients on an objective appraisal of their safety and clinical efficacy. 

The evidence submitted by manufacturers when seeking approval of their high-risk devices must be publicly available, including technical performance and premarket clinical studies. Giving physicians access to this information supplements the peer-reviewed scientific literature and might be essential for comparing alternative devices within any class. Interested patients should be encouraged to review the evidence for any device that has been recommended for them. 

The new EU law on medical devices states that the manufacturer is to prepare a summary of the evidence for any implantable or high-risk device.

Read The Lancet article

Michael Wonder

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Michael Wonder