Hello all,
Simple question for the smart people of this forum. We are conducting a few global studies using our CE marked, Class IIb device, that I am preparing the PMCF Plan/Report for. In one of the studies, a different device (also manufactured by us) is used in addition to our Class IIb device, and the whole point of the study is to assess the safety and performance of that different device. The Class IIb device is still used in accordance with its CE marked indication in this study.
Do I have to call this out as a PMCF study? I would like to leave it out with the justification that it does not provide any data that addresses gaps in the clinical evidence (that are not otherwise addressed by other studies). Can I just reference this study in the CER as a sponsor-initiated study and cover the safety/performance there? Or are any sponsor-initiated studies using a particular CE-marked device required to be called a PMCF study?
Thanks in advance!
Simple question for the smart people of this forum. We are conducting a few global studies using our CE marked, Class IIb device, that I am preparing the PMCF Plan/Report for. In one of the studies, a different device (also manufactured by us) is used in addition to our Class IIb device, and the whole point of the study is to assess the safety and performance of that different device. The Class IIb device is still used in accordance with its CE marked indication in this study.
Do I have to call this out as a PMCF study? I would like to leave it out with the justification that it does not provide any data that addresses gaps in the clinical evidence (that are not otherwise addressed by other studies). Can I just reference this study in the CER as a sponsor-initiated study and cover the safety/performance there? Or are any sponsor-initiated studies using a particular CE-marked device required to be called a PMCF study?
Thanks in advance!