1. There are some differences in CEP requirements in MEDDEV 2.7/1, rev 4 and MDR. Are all MEDDEV requirements still applicable?
2. MDR Annex XIV... what exactly means "an indicative list and specification of parameters to be used to determine, based on the state of the art in medicine, the acceptability of the benefit-risk ratio for the various indications and for the intended purpose or purposes of the device"? Does anyone has any example?
2. MDR Annex XIV... what exactly means "an indicative list and specification of parameters to be used to determine, based on the state of the art in medicine, the acceptability of the benefit-risk ratio for the various indications and for the intended purpose or purposes of the device"? Does anyone has any example?