Clinical Evaluation and Role of notified Bodies

The body notified must when the evidence derived from clinical studies is based in part or completely on data from devices that are said to be equivalent to the device being evaluated evaluate the appropriateness of using these data. The body notified must be able to clearly document its findings on the claimed equivalence as well as on the validity and relevance of the evidence to demonstrate the validity. Any characteristic of the device that is claimed to be unique by the manufacturer or with regard to new indications, the body notified must determine the extent to which the claim is supported by clinical and preclinical evidence and risk analysis.

The notified body must ensure that the evidence from clinical studies and the clinical assessment is sufficient and will confirm the conclusions made by the manufacturer regarding the compatibility with generally accepted safety as well as performance standards. This verification should take into account the appropriateness of the risk-benefit determination and risk management plan of the product, the instruction for use as well as the training for users and the post-market surveillance program, and includes an evaluation of the need of, and sufficiency of the PMCF plan that is proposed, when appropriate.

Based on its evaluation of the evidence from clinical studies, the notified body will take into consideration the clinical evaluation and the determination of benefit-risk and whether milestones must be identified in order for the notified body to evaluate any updates on the scientific evidence resulting from post-market surveillance as well as PMCF information. The notified body should clearly document the result of its evaluation in the report on the clinical evaluation assessment.

The notified body must send the manufacturer an assessment report of an assessment of the technical document. This includes a report on the assessment of clinical efficacy. If the device meets the applicable provisions of the MDR medical device regulations The notified body must give an EU technical certification of documentation. The certificate must include the findings of the technical document evaluation; the conditions for the certificate's validity, details required for identifying the design that has been approved and, where applicable a description of the purpose for which was designed the device.

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