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 according to the manufacturer’s Instructions for Use.
Note: In exceptional cases where an instruction for use is not required, the collection, analysis and
assessment are conducted taking into account generally recognized modalities of use.
The clinical evaluation of medical devices is the assessment procedure conducted by registration applicants to validate whether the application requirements or intended use of the device(s) under application can be achieved based on clinical literatures, clinical experience data and information gathered from the clinical trial(s). This Guidance is to provide technical guidance to registration applicants for conducting clinical evaluation and to food and drug administrative authorities for reviewing the clinical evaluation data.
Medical Device Clinical Evaluation is a process to check how safe, how effective and how well a medical device performed in HUMANS