医療機器の臨床評価報告書の評価 （英語）

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Clinical evaluation

Article 61 and Annex XIV of the MDR outline the necessary steps and requirements for conducting a clinical evaluation. Regardless of their classification, all medical devices that shall be subject of a conformity assessment under the MDR require a clinical evaluation. Clinical evaluation is a systematic and planned process to continuously generate, collect, appraise, analyse, and evaluate the clinical data to demonstrate the safety and performance, including clinical benefits, of the medical device under assessment when used as intended by the Manufacturer. A clinical evaluation may also be based on clinical data relating to a medical device for which equivalence to the device under evaluation can be demonstrated.

A clinical evaluation must be thorough and objective and must consider both favourable and unfavourable clinical data. The manufacturer shall specify and justify the level of evidence necessary to demonstrate conformity with the relevant general safety and performance requirements. Its depth and extent shall be proportionate and appropriate to the classification, intended purpose and risks of the medical device in question, as well as to the Manufacturer’s claims.

In addition, there are multiple MDCG guidelines that can be taken into consideration, specifically MDCG 2020-13.

CLINICAL EVALUATION PLAN (CEP)

The CEP is the backbone of clinical evaluation and outlines the methodology, objectives, and criteria for conducting clinical evaluation providing a structured approach to gathering, appraising, analyzing, and interpreting clinical data. CEP must follow the requirements laid out in Annex XIV, Part A, 1.a of the MDR.

CLINICAL EVALUATION REPORT (CER)

The results of the clinical evaluation and the clinical evidence must be documented in a clinical evaluation report which is part of the conformity assessment of the device under evaluation.

The clinical evidence together with non-clinical data generated from non-clinical testing methods and other relevant documentation shall allow the manufacturer to demonstrate conformity with the general safety and performance requirements.

The clinical evaluation shall be kept up to date throughout the lifecycle of the device under evaluation (MDR Art 61.11).

For further guidance see MDCG 2020-13.