Conducting a clinical evaluation under the EU MDR can be a complex and demanding process. Even experienced teams can fall into common pitfalls that jeopardise the success of their submissions.
In this video, we highlight the most frequent mistakes manufacturers make during clinical evaluations and share practical strategies to avoid them. You’ll also discover key resources and guidelines that can help ensure your clinical evaluation meets all regulatory requirements.
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
This video explores five major pitfalls that often derail clinical evaluations:
- Lack of a proper search protocol
Simply listing research questions and search terms isn’t enough. A robust protocol must detail how sources will be identified, appraised, and analysed. - Lack of safety and performance objectives
Clinical evaluations must be grounded in explicit, measurable safety and performance objectives. These benchmarks, derived from the state of the art, are essential for demonstrating conformity and ensuring that devices meet clinical expectations. - Choosing the wrong route to conformity
Legacy strategies no longer suffice. Under MDR, equivalence is far harder to justify, and Article 61(10) is frequently misapplied. Manufacturers must critically assess the most appropriate route early in the process to avoid regulatory setbacks. - Improper use of equivalence
Under the MDR, demonstrating equivalence requires detailed justification across technical, biological, and clinical characteristics. Full access to the equivalent device’s technical documentation is typically needed. Anything less risks rejection. - Absence of quantitative benefit-risk assessment
The MDR raises the bar: qualitative arguments are no longer sufficient. A numerical benefit-risk ratio is now mandatory, signalling a shift toward more data-driven evaluations.
By understanding these pitfalls and using the recommended guidance, manufacturers can strengthen their clinical evaluations and improve submission success rates.
Key resources for Clinical Evaluation under EU MDR
- The EU MDR
- MDCG Guidelines:
- MEDDEV2.7/1 Rev 4. Clinical Evaluation: A guide for manufacturers and notified bodies under directives 93/42/EEC and 90/385/EEC
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 have shared that expertise with you, helping you avoid the pitfalls we see most often and giving you a clear pathway to stronger, more resilient submissions.
