Clinical Evaluation Reports (CERs) are critical in showing that a medical device meets safety and performance standards for TGA submissions. Clinical evidence is not only required at the time of initial ARTG inclusion; it must also be maintained and available the entire time the device is on the register.
However, clinical evaluation reports mistakes are common and can lead to delays or rejections. These issues often prompt additional scrutiny and may lengthen the review process.
Common Issues Found in Clinical Evaluation Reports
CERs may fall short when they include vague summaries, lack direct links to clinical data, or rely on outdated literature. In some cases, sponsors fail to establish valid equivalence claims or overlook known risks associated with the device. These gaps highlight the importance of up-to-date knowledge through medical device regulatory training.
How to Improve CER Submissions
Strong CERs include peer-reviewed evidence, updated references, clear clinical outcomes, and well-documented post-market surveillance. Reports should follow TGA-recognised formats and provide direct, relevant support for all claims.
Reduce Delays with High-Quality Evaluations
As regulatory requirements evolve, the pressure on clinical reporting will increase. Avoid clinical evaluation reports mistakes by preparing submissions that are accurate, detailed, and fully aligned with TGA expectations.