CER Flashcards
Benefit-Risk Determination
assessing whether benefits, when used as intended, outweigh risk to patient
clinical benefit
a quantitated positive impact
clinical data
safety or performance information from use of device
clinical data sources:
clinical investigations of device in question
clinical investigations of equivalent devices
published data using device in question
published data using equivalent device
PMCF
PMCF
post-market clinical follow-up
clinical evidence
generated by clinical evaluation
clinical evaluation
a systematic process to generate, collect, analyze and assess clinical data of a device. verifies benefits when used as intended as per IFU.
IFU
instructions for use
Clinical Performance
ability of device to achieve intended purpose when used as intended
clinical side effect
forseeable undesired effect of device when used as intended
off-label use
device used in way that deviates from IFU
similar device/ benchmark device
devices belonging to same generic device group. in MDR defined as having same intended purposes or commonality of technology.
