Clinical Evaluation Report (CER)

Clinical Evaluation report (CER) has the summary and inferences of the evaluation of all the relevant clinical data documented or referenced in other parts of the Technical File documentation.

"The clinical evaluation report and the relevant clinical data constitute the clinical evidence for conformity assessment"

Clinical Evaluation is a paramount aspect of CE Mark certification process because it guarantees that the evaluation of safety and performance of the device is based on adequate clinical evidence throughout the lifetime that the medical device is on the market.

This continuous process enables manufacturers to handover the notified bodies and competent authorities with sufficient clinical evidence for the demonstration of conformity of the device with the Essential Requirements throughout its lifetime (for example: for CE marking, completion of post-market surveillance and reporting necessities, or during surveillance processes).

Updating the Clinical Evaluation Report

The manufacturer should specify and substantiate the frequency at which the clinical evaluation needs to be actively updated.

The clinical evaluation should be actively updated

1. When the manufacturer collects new information from PMS that has the potential to change the current evaluation. As a manufacturer, one should establish a PMS system with a well-defined scope and nature in line with the intended purpose of the device that consistently monitors the clinical performance and clinical safety of the device as part of their quality management system. PMS should systematically generate new data, such as safety reports, results from published literatures, registries, PMCF studies, and other data about device usage. Those data need to be evaluated for information that has a potential to change the evaluation of the benefit-risk profile, and the clinical performance and clinical safety of the device. These data are required to be fed into the clinical evaluation files in a timely manner. In agreement with the Regulatory Directives, the clinical evaluation and the clinical evaluation report must be actively updated with data obtained from post-market surveillance.

If no such information is received, then CER should be updated:

• at least annually if the device carries serious risks or is not yet well established; or
• every 2-5 years, if the device is not expected to transmit serious risks and is well established, a justification should be provided.

When involvement of notified bodies is required, updates are usually coordinated with the notified body. Usually, they are lined up with the timetable for surveillance audits and the renewal of the certificates.

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Ms. Asha Meria Johnson B. Tech, MS, is a senior medical device regulatory consultant and Team Lead. She received her graduation from University of Calicut, India, and post-graduation from NJIT, USA.