When health economics actually matters in your CER

Written by HATEM RABEH, MD, MSc Ing

Your Clinical Evaluation Expert And Partner

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This happens more often than it should. Manufacturers who believe that demonstrating cost savings or health economic value fulfills the clinical evaluation requirement. It does not.

The confusion is understandable. In health technology assessment (HTA), economic outcomes are central. In reimbursement discussions, they dominate. But clinical evaluation under MDR Article 61 has a different purpose and a different structure.

The question is not whether health economics matter. They sometimes do. The question is when they matter, how they integrate into the evidence hierarchy, and what happens when you confuse them with clinical performance or safety data.

What MDR Actually Requires

MDR Article 61 requires manufacturers to demonstrate that their device achieves its intended performance and that the clinical benefits outweigh the clinical risks when used as intended. This demonstration must be based on clinical data.

Clinical data means information concerning safety or performance obtained from clinical use. Not financial projections. Not resource utilization models. Not quality-adjusted life years calculated from assumptions.

MDCG 2020-6 on sufficient clinical evidence clarifies that the evidence base must address clinical safety and clinical performance directly. The regulation is explicit about the hierarchy: clinical investigations generate the strongest evidence, followed by clinical literature, and then other sources when justified.

Economic outcomes do not appear in this hierarchy as standalone evidence.

But this does not mean economic data is never relevant.

Where Economic Outcomes Actually Fit

There are specific situations where health economic outcomes strengthen or contextualize clinical evidence. Not as primary evidence, but as supporting information that helps interpret clinical benefit.

The most common legitimate use case is when economic outcomes inform benefit-risk analysis. If two treatment options have similar clinical outcomes but substantially different resource utilization, that context can influence how clinical benefit is interpreted in real-world settings.

For example, a device that achieves the same reduction in symptoms as standard of care but requires half the follow-up visits may offer additional practical benefit. That practical benefit is not the clinical benefit itself, but it contextualizes adoption and real-world utility.

Another valid scenario is when economic outcomes appear in published clinical studies that form part of your literature review. If a randomized controlled trial reports both clinical endpoints and cost-effectiveness, you include the full study in your appraisal. But you extract and weigh the clinical data primarily, and reference the economic data as context.

The third scenario, which is rarer but important, is when economic outcomes indirectly signal clinical value in settings where direct clinical endpoints are weak. This typically applies to diagnostic devices or decision-support tools where improved resource allocation reflects improved clinical decision-making.

But even here, the clinical reasoning must be explicit. You cannot jump from cost savings to assumed clinical benefit without demonstrating the clinical pathway.

The Problem With Overreliance on Economic Data

What breaks down in practice is proportion and framing. I have seen clinical evaluation reports where economic data dominates the discussion of clinical benefit. Charts showing cost per quality-adjusted life year. Tables comparing hospital resource use. Projections of healthcare system savings over five years.

None of this is inherently wrong. But when it takes up more space than the analysis of actual clinical performance data, it signals misunderstanding.

The reviewer reads this and asks: where is the evidence that the device actually performs as intended? Where are the clinical outcomes that justify this device existing? What are the safety signals, and how were they characterized?

If those core questions are not answered with clinical data first, economic data looks like distraction. Even if the economic models are methodologically sound.

Another problem is that economic outcomes often rely on assumptions that are not clinically validated. A model might assume that faster diagnosis leads to earlier treatment and therefore better outcomes. But if the clinical literature does not support that assumption in the specific disease context, the economic model does not strengthen your case. It weakens it by exposing gaps in your clinical reasoning.

This is particularly visible in equivalence claims. Manufacturers sometimes argue that a device is equivalent to another based on similar cost profiles or resource utilization patterns, without demonstrating equivalent clinical performance through direct comparison or robust clinical data.

Equivalence under MDR Annex XIV requires clinical evidence of comparable safety and performance. Economic similarity does not establish clinical equivalence.

When Health Economics Misleads the Evaluation

There is a subtler risk that appears when economic data is used to infer clinical benefit without direct clinical evidence. This happens most often with digital health devices, remote monitoring systems, and workflow optimization tools.

A manufacturer develops a device that reduces hospital readmissions. They present a health economic analysis showing significant cost savings per patient. The analysis is credible. The modeling is solid.

But the clinical evaluation report does not explain why readmissions decreased. Was it because the device detected deterioration earlier? Was it because the device improved medication adherence? Was it because the device prompted behavioral changes in patients or clinicians?

Without answering that mechanistic question, the economic data does not support clinical benefit. It suggests benefit, but suggestion is not sufficient clinical evidence.

The reviewer will ask: what clinical endpoints were measured? How was device performance validated? What is the clinical pathway from device use to reduced readmissions?

If the manufacturer cannot answer with clinical data, the economic data becomes a problem rather than support. It raises the question of whether the manufacturer is trying to bypass the clinical evidence requirement by presenting economic evidence instead.

This is not a theoretical concern. I have seen Notified Body deficiency letters that explicitly state: “The applicant has presented health economic modeling without sufficient underlying clinical evidence to support the claimed clinical benefit. Provide clinical performance data that demonstrates the mechanism by which the device achieves the claimed outcome.”

How to Use Economic Data Appropriately

When economic data is relevant to your device, include it in context, not as primary evidence. Structure your clinical evaluation report so that clinical performance and clinical safety are established first with clinical data. Then, if economic outcomes add meaningful context, present them in a supplementary section or as part of the benefit-risk discussion.

Be explicit about what the economic data does and does not show. If a study reports cost-effectiveness alongside clinical outcomes, state clearly: “This study demonstrates clinical benefit through [specific endpoint]. The accompanying economic analysis provides context on resource utilization but was not used to establish clinical benefit.”

If economic outcomes appear in your PMCF plan, frame them as secondary objectives that provide real-world context, not as primary endpoints for demonstrating performance or safety. PMCF must generate clinical data that confirms safety and performance in real-world use. Economic data can be collected simultaneously, but it does not fulfill the PMCF requirement on its own.

In benefit-risk analysis, you can reference economic data to strengthen the argument for clinical benefit when clinical outcomes are marginal or when comparative analysis shows similar efficacy. But always tie the economic argument back to clinical reasoning. Show the pathway from device use to clinical outcome to economic impact.

For example: “The device reduces procedure time by 15 minutes on average, as demonstrated in [clinical study]. This reduction translates to improved patient throughput and reduced resource utilization per procedure [economic analysis]. The clinical benefit is the reduced procedure time with maintained safety profile, while the economic data contextualizes practical adoption considerations.”

Notice the structure: clinical evidence first, economic context second, and explicit statement of what constitutes clinical benefit.

The Reimbursement Confusion

Part of the confusion around economic data in clinical evaluation comes from the proximity of regulatory submission and reimbursement dossiers. Manufacturers prepare both around the same time, often using the same studies and datasets.

But the two processes have different standards and different purposes. Reimbursement authorities want to know if the device offers value for money within healthcare budgets. Regulatory authorities want to know if the device is safe and performs as intended.

These questions overlap but are not identical. A device can be clinically effective and not cost-effective. A device can be cost-effective in specific healthcare systems but not meet clinical performance requirements under MDR.

The problem arises when manufacturers treat the clinical evaluation report as a hybrid document that tries to serve both regulatory and reimbursement purposes. This dilutes the regulatory focus and creates gaps that Notified Bodies identify immediately.

Keep the clinical evaluation report focused on what MDR demands: clinical safety and clinical performance based on clinical data. If you need to prepare a separate health economics dossier for reimbursement or HTA, do so. The clinical evaluation report is not the place for that full analysis.

What Reviewers Look For

When I review a clinical evaluation report that includes economic data, I look for proportion and integration. Is the economic data presented as supplementary context or as primary evidence? Is it tied back to clinical endpoints or floating independently?

If economic data appears early in the report or in the section on clinical performance, that is a warning sign. It suggests the manufacturer may be relying on economic outcomes to substitute for clinical evidence.

If economic data appears late in the report, in the benefit-risk section or as part of post-market considerations, that is more appropriate. It signals that the manufacturer understands the hierarchy and is using economic data to contextualize clinical benefit, not establish it.

Notified Bodies apply similar logic. They expect clinical evaluation reports to demonstrate clinical benefit through clinical data first. Economic data can add value, but only after the core clinical case is made.

This is not about dismissing economic data. It is about recognizing that clinical evaluation under MDR has specific requirements that economic data alone cannot fulfill.

Final Considerations

Health economic outcomes have a place in the broader regulatory and commercial landscape. They inform reimbursement, market access, and real-world adoption. But within the clinical evaluation report, their role is limited and specific.

Use economic data when it genuinely adds context to clinical benefit. Do not use it to bypass the need for direct clinical evidence. Do not let economic modeling dominate the analysis of clinical performance.

The clinical evaluation report must answer the clinical questions first. If you cannot demonstrate clinical benefit with clinical data, economic data will not save the submission. If you can demonstrate clinical benefit with clinical data, economic data may add useful context but is rarely decisive.

Keep your focus on what MDR Article 61 demands. Clinical data supporting safety and performance. Economic outcomes are downstream from that requirement, not a substitute for it.

Peace,
Hatem
Clinical Evaluation Expert for Medical Devices
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