TY - JOUR AU - Wild, Claudia AU - Erdös, Judit AU - Zechmeister, Ingrid PY - 2014 DA - 2014/11/04 TI - Contrasting clinical evidence for market authorisation of cardio-vascular devices in Europe and the USA: a systematic analysis of 10 devices based on Austrian pre-reimbursement assessments JO - BMC Cardiovascular Disorders SP - 154 VL - 14 IS - 1 AB - European medical device regulation is under scrutiny and will be re-regulated with stricter rules concerning requirements for clinical evidence for high-risk medical devices. It is the aim of this study to analyse the differences between Europe and USA in dealing with risks and benefits of new cardio-vascular devices. SN - 1471-2261 UR - https://doi.org/10.1186/1471-2261-14-154 DO - 10.1186/1471-2261-14-154 ID - Wild2014 ER -