In a published response to the article "Medical devices: EU approval system leaves door open for dangerous devices" (BMJ online, 24 October 2012), Prescrire, together with the AIM, ESIP, the ISDB and the MiEF, underlines the failings of the European device regulation as demonstrated by the recent BMJ investigation, and recommends several important changes if patient safety is to be at the heart of the new regulation.