MDD (Medical Devices Directive) review will take care of German risk regrade plans?
This article was originally published in Clinica
Whether the German authorities will actually press for the reclassification of the products they wish to see in a higher risk category, including as ventricular assist devices and body-worn pumps, remains uncertain. Sources close to the authorities suggests that there may be other options for ensuring that these products are safer without a total reclassification.
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