Class I devices: must they have clinical data or clinical investigations?
This article was originally published in Clinica
Executive Summary
Manufacturers of class I devices are often perplexed over the issue of clinical data: is it required for regulatory purposes, even though the devices in question have been classed as low-risk? And should the devices also undergo clinical investigations, as with higher-risk devices? Or is it good commercial sense to produce strong clinical data, perhaps based on specifically-designed clinical investigations, anyway, to convince purchasers and would-be investors of the product's value?