Under the EU MDR, a well-defined Clinical Evaluation Plan (CEP) and a clearly structured Clinical Evaluation Report (CER) are essential to the clinical evaluation process.
Together, they form the backbone of a device’s regulatory narrative, guiding reviewers through the evidence that supports its safety, performance, and conformity with applicable requirements.
In this fourth episode of our Guide to Clinical Evaluation video series, we take a closer look at the CEP and CER. We explain how the CEP sets the strategy for gathering clinical evidence and how it informs the structure of the CER.
This video covers:
- The purpose of the CEP and how it sets the strategy for clinical evidence gathering
- Key elements such as device description, GSPRs, route to conformity, and literature search methodology
- How the CER builds on the CEP to present clinical data, demonstrate conformity with the GSPRs, and justify the device’s safety and performance through comparison of outcomes against the CEP objectives and a quantitative benefit–risk analysis.
A Proven Framework for Success
At Mantra Systems, we know what success looks like. Our approach to clinical evaluation is built on experience: over 300 successful evaluations conducted under MDR. This track record reflects not just regulatory knowledge, but also a deep commitment to patient safety, clinical relevance, and quality of evidence.
Through this series, we’ll share that expertise with you, helping you avoid the pitfalls we see most often and giving you a clear pathway to stronger, more resilient submissions.
Subscribe to our newsletter to keep up with the full five-part series on mastering MDR clinical evaluation.
If you missed previous episodes. Catch up here:
- What is clinical evaluation?
- Clinical evaluation in context
- The State-of-the-Art (SOTA) review – core of a successful submission
- The CEP and CER
- Clinical evaluation pitfalls and useful resources
