Clinical Evaluation of Equivalent Devices

Clinical Evaluation of Equivalent Devices What extent of data of medical devices from other manufacturers does needed to demonstrate equivalence? Annex XIV (3) EU MDR, for instance, refers to non-implantable devices of risk classes I – IIb. It specifies, that manufacturers must provide clear evidence that they have sufficient access to the data of the…

Medical Device Clinical Evaluation

What is Medical Device Clinical Evaluation

What is Medical Device Clinical Evaluation Medical Device Clinical Evaluation : CE is a methodologically sound ongoing procedure to collect, appraise and analyze the clinical data pertaining to a medical device and to evaluate whether there is sufficient clinical evidence to confirm compliance with relevant essential requirements for safety and performance when using the device…