Knowing whether your Clinical Evaluation meets Notified Body expectations is more challenging than ever. Regulations are evolving, guidance is frequently updated, and internal interpretations don’t always align with external expectations.
According to the 2024 MedTech Survey, 50% of manufacturers experienced significant delays or even negative outcomes due to their Clinical or Performance Evaluations being challenged. Therefore, ensuring your CER is robust and aligned with current standards is critical.
A key challenge: How much Clinical Evidence is enough?
One significant challenge in meeting EU MDR requirements lies in generating and justifying sufficient Clinical Evidence. Manufacturers must not only provide data that demonstrates the device’s safety and performance in accordance with Annex I, but also justify that the quantity and quality of evidence is appropriate for the device’s intended use and risk classification. Although the requirement seems clear, determining what constitutes “enough” Clinical Evidence is often not straightforward.
Beyond the volume of data, the way evidence is presented and assessed is also critical. Manufacturers must demonstrate that their device is the state-of- the-art, which requires a structured, quantitative comparison against safety and performance benchmarks. By meeting these objectives, a device can clearly demonstrate its clinical benefits and favourable safety profile over similar devices and comparable alternatives. When this is not clearly demonstrated, the result is often non-conformities.
The Consequences of Non-Conformities
These non-conformities can carry serious consequences: repeated review cycles, increased regulatory costs, and, most critically, delays in product launches or interruptions to market access. Once a Notified Body identifies a deficiency, addressing it usually involves far more than simple revisions. It may require a complete reassessment of the clinical evaluation strategy, updates to literature reviews and risk management documentation, or revisions to post-market clinical follow-up (PMCF) plans. These are not quick fixes, they are time-intensive efforts that can significantly impact timelines and resources.
Take a Proactive Approach with Pre-Submission Reviews
Identifying deficiencies in your Clinical Evaluation Report (CER) before submission is essential to avoiding delays, non-conformities, and costly remediation efforts. Conducting a structured, pre-submission review can help you:
- Assess whether the clinical justification and level of evidence provided are appropriate for the device’s intended purpose and risk classification.
- Identify weaknesses in your clinical evaluation strategy.
- Ensure alignment with the most recent EU MDR expectations, including evolving MDCG guidance and interpretations.
- Reduce the likelihood of rework, multiple review cycles, and associated delays in market access.
Bringing in an experienced, independent reviewer can offer objective insight and identify potential issues that may be overlooked by internal teams. This additional layer of review enhances the robustness of the CER and supports a more efficient and successful conformity assessment process.
Confidence, Not Just Compliance
In today’s regulatory environment, meeting the expectations of Notified Bodies under the EU MDR requires more than simply compiling data; it demands a strategic, evidence-driven approach to Clinical Evaluation. With evolving guidance, increasingly rigorous scrutiny, and the risk of non-conformities leading to costly delays or market access issues, manufacturers can no longer afford to take a reactive approach.
At Mantra Systems, we offer focused, expert-led Clinical Evaluation Pre-Submission reviews designed to identify weaknesses early, provide practical recommendations, and ensure your CER stands up to regulatory scrutiny. If you’re preparing a submission or simply want to strengthen your documentation, a proactive review may be a valuable step toward a more confident and efficient path to compliance.
