Empowering regulatory science for medical devices in Europe.

From clinical and ethical perspectives, the need for scientific evidence establishing safety and efficacy of high-risk therapeutic medical devices, and for transparency of that evidence, is similar to new drugs-but requirements for devices and drugs have developed quite differently. The first European system for evaluating new devices applied a framework that had been developed for industrial products. Despite reforms the same flawed structure persists, as a fundamental obstacle to the uniform application of clinical standards, adherence to the principles of open science, and flexibility to respond to innovations. In this Viewpoint, we summarise how the regulatory system evolved and review how it needs to change, for the assessment and approval both of implantable devices and of laboratory diagnostic tests. There are too few clinically-qualified regulators within the EU governing institutions, so substantial investment is needed to boost scientific expertise within a central coordinating unit. Clinicians and scientists must support these changes by developing shared principles with regulators. Some colleagues within each medical speciality should develop expertise in 'regulatory science'.