With the implementation of EU MDR, clinical evaluation has taken the center stage with its significance elevated to be one of the crucial elements in a technical documentation.
This means that the documentation of clinical evaluation is under heightened scrutiny during MDR audits and submissions, which increases the risk of deficiency findings. A data collected from our experience shows exactly that. We found that deficiencies found in clinical evaluation (as a category) accounted for 12% of all deficiencies, making it the fourth place among other categories. Interestingly, clinical evaluation reports had the third highest number of deficiencies in any document only trailing biocompatibility and instructions for use.
- Verification & Validation: 36%
- Labeling: 16%
- Manufacturing: 13%
- Clinical evaluation: 12%
Deficiencies in clinical evaluation are often critical in nature that can lead to serious consequences. Clinical evaluation now holds keys to validation of indications and many details in instruction for use, the centerpiece of device information that permeates in all aspects of technical documentation. This means that deficiencies found in clinical evaluation documents have implications far beyond the documents themselves. It can lead to non-compliance and stoppage of device sales.
To avoid costly rework of clinical evaluation or non-compliance, it is important to anticipate and mitigate potential pitfalls in clinical evaluation that can lead to deficiency findings during submissions or audits. In our blog, we present case studies of deficiencies found in clinical evaluation based on our past experience.