医疗器械临床评价常见误区浅析

Analysis of Common Misunderstandings in Clinical Evaluation of Medical Devices

《医疗器械临床评价技术指导原则》中提出的三种临床评价路径,对每一种评价路径都有着明确的指引和要求,申请人根据不同的评价路径提供相应的临床评价证据来评价产品的安全有效性,但是在实操过程中仍有不少对临床评价理解的误区,本文将对其中常见的误区进行浅析。

There are three clinical evaluation paths proposed in the technical guidelines for clinical evaluation of medical devices,which have clear guidelines and requirements for each evaluation path.The applicant provides corresponding clinical evaluation evidence according to different evaluation paths to evaluate the safety and effectiveness of the product.However,there are still many misunderstandings about clinical evaluation in the process of practical operation Error analysis.