A clinical evaluation is the assessment and analysis of clinical data pertaining to a medical device to verify its clinical safety and performance. The requirements for clinical evaluations are outlined in MDD 93/42/EEC Annex 1, but some manufacturers don’t have history with the process. They could be facing challenges and rejections by the reviewers.

A clinical evaluation must be performed by device manufacturers pursuing the CE Mark prior to marketing the device in the European Union.¹ Clinical evaluations are also repeated periodically as new clinical safety and performance information about the device is obtained.

The manufacturer demonstrates the device achieves its intended performance and that the risks and any adverse events are minimized and acceptable when weighed against the benefits. Claims made about the device’s performance and safety are supported by suitable evidence.

With regard to postmarket activities, manufacturers are expected to implement and maintain surveillance programs that routinely monitor the clinical performance and safety of the device as part of their quality management system (QMS). The QMS should use data generated from safety reports, including adverse event reports, results from published literature, any further clinical investigations, and formal post market surveillance studies.

The stages of a clinical evaluation are outlined in Figure 1.

Collecting Data

The literature review must be complete, covering pre- and postmarket data and any clinical investigations. Common sources for data are as follows:

In collecting data, it’s helpful to capture screen prints of searches, including the search terms and exact logic used in the search. Boolean logics such as “AND” and “OR” show repeatability and help the reviewers in analyzing the resulting clinical evaluation.

For published literature, it’s common for thousands of data sources to be identified.

Data Evaluation: The Heavy Lifting in Clinical Evaluations

After collecting the data, the next step is assessing the content and determining whether the data should be considered for the clinical evaluation.

A scoring table can be useful for determining whether to include data. For example, data might be scored on factors such as device equivalency, application equivalency, similarity of operator, and demographic equivalency.

For studies that pass the scoring table, each must be summarized on how they support the essential requirements (see sidebar “The Clinical Evaluation Process”). A common mistake is simply copying the conclusion of the study instead of how it relates to the essential requirements.

Insights from the Experts

The clinical evaluation must be recreatable by third parties based on the process and scoring system outlined in the report. If the notified body can’t recreate it, they have no recourse except to find deficiency.

Make it easy for the reviewers to check off each step. Highlight what they’re looking for relative to what you’re covering. Refer to guidances and standards. The European Commission: Clinical Evaluation: a guide for manufacturers and notified bodies features helpful appendices.

Common errors can include the following:

Conclusion

Clinical evaluations include the assessment and analysis of the medical device’s clinical data to verify its clinical safety and performance. The stages are well-defined but can be intensive. A thorough clinical evaluation can involve thousands of data sources and significant time for proper assessment. Manufacturers should submit evaluations that are recreatable and make it easy for reviewers to follow.

Notes

Chris Henza is a Regulatory Affairs Specialist with Regulatory Compliance Associates, Inc. She specializes in Clinical Evaluations.