Article 61(10): When ‘No Clinical Data’ Still Means Clinical Work

Written by HATEM RABEH, MD, MSc Ing

Your Clinical Evaluation Expert And Partner

in
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Article 61(10) addresses devices where clinical investigations or clinical data are not deemed necessary. The wording confuses many teams. They interpret it as exemption. But no clinical data does not mean no clinical evaluation.

It means the evaluation follows a different structure. You still perform the work. You still write the report. You still justify every claim. The reasoning just shifts from analyzing clinical performance data to demonstrating why such data is not required.

Let me walk you through what this actually means in practice.

What Article 61(10) Actually Says

The MDR states that clinical investigations are not deemed necessary when the device has been designed by adopting solutions sufficiently established within clinical practice and its characteristics allow full use of existing clinical data from equivalent devices.

Three conditions must be met simultaneously. The device must be based on established solutions. The clinical performance must be sufficiently predictable. And equivalent devices with adequate clinical data must exist.

This is not a checkbox. This is a detailed justification that you defend in the clinical evaluation report.

The distinction matters because many teams confuse clinical investigation with clinical evaluation. They are not the same process. Clinical investigation is one way to generate clinical data. Clinical evaluation is the systematic assessment of all relevant data to demonstrate safety and performance.

You can have a clinical evaluation without a clinical investigation. You cannot skip the clinical evaluation entirely.

Why Manufacturers Misinterpret This Article

The confusion comes from two places. First, the heading in some interpretations reads “devices without clinical data.” This is misleading. The device may not have its own clinical investigation data, but it must still be supported by clinical data from equivalent devices.

Second, teams conflate established technology with automatic acceptance. Just because the core technology has been used for decades does not mean your specific implementation is automatically validated.

I have seen this pattern repeatedly. A manufacturer modifies an existing product. They add a new coating. They change the size slightly. They adjust the intended use. Then they write in the CER: “Based on established technology, no clinical data required.”

But they never demonstrate equivalence to devices with clinical data. They never explain why the modifications do not affect clinical performance. They never justify why existing data is sufficient for their specific device.

What triggers rejection is not the absence of a clinical investigation. What triggers rejection is the absence of reasoning.

What You Must Demonstrate

When you claim Article 61(10) applies, your clinical evaluation report must contain three core demonstrations.

Established Solutions

You must show that the design solutions used in your device are sufficiently established in clinical practice. This means more than proving the technology exists. You must demonstrate that the specific combination of materials, mechanisms, and intended use has been consistently applied with predictable outcomes.

This requires literature review. You cite clinical studies, systematic reviews, registries, and post-market surveillance data that show how similar solutions perform in real-world use.

The key word is predictable. If the clinical performance cannot be reliably anticipated based on existing knowledge, then the solution is not sufficiently established.

Technical, Biological, and Clinical Equivalence

You must identify equivalent devices and demonstrate that your device shares the same technical characteristics, biological interaction, and clinical performance profile.

Equivalence is not similarity. It is not “close enough.” It is a detailed comparison that shows your device does not introduce new risks or performance uncertainties.

This follows the same structure required for equivalence-based clinical evaluation under Article 61(5). You analyze design, materials, specifications, intended use, and clinical claims. You explain any differences and justify why those differences do not affect the applicability of the equivalent device data.

If you cannot demonstrate equivalence, then Article 61(10) does not apply. You need your own clinical data.

Adequate Existing Clinical Data

You must show that sufficient clinical data exists for the equivalent devices. Sufficient means adequate in quality, quantity, and recency to support all claims you make about your device.

This is where many submissions fail. The manufacturer identifies an equivalent device, but they do not access the clinical data. They cite the existence of the device as proof. That is not enough.

You need the actual data. You need clinical studies, PMCF reports, post-market surveillance summaries, literature on clinical outcomes. You need to appraise that data and explain how it supports your specific claims.

The Structure of the Report

The clinical evaluation report for a device under Article 61(10) follows the same MDCG 2020-13 template as any other CER. The structure does not change. What changes is how you populate each section.

In the scope definition, you state clearly that no clinical investigation was performed and that you rely on Article 61(10). You reference the justification that follows.

In the clinical background section, you provide the established knowledge. You cite clinical literature, guidelines, standards. You explain how the technology has been used historically and what clinical outcomes are expected.

In the device description, you detail your device specifications and explain which design features are based on established solutions.

In the equivalence section, you present the equivalent device analysis. You provide the comparison table. You explain each difference. You cite the clinical data from those devices.

In the appraisal of clinical data section, you evaluate the quality and relevance of the data from equivalent devices. You apply the same rigor as if it were your own data.

In the analysis of clinical performance and safety, you demonstrate that the existing data supports your claims. You address each intended use, each performance claim, each known risk.

The report is not shorter. It is not simpler. The work is redirected, not reduced.

When Article 61(10) Does Not Apply

There are clear cases where you cannot invoke Article 61(10). Recognizing them early saves time and avoids rejection.

If your device introduces a novel mechanism of action, Article 61(10) does not apply. The solution is not established if the clinical interaction is new.

If your device is used in a new clinical indication, Article 61(10) does not apply. Even if the technology is established, using it in a different patient population or condition changes the clinical context.

If you cannot identify equivalent devices with adequate clinical data, Article 61(10) does not apply. Equivalence is not optional. It is the foundation of the argument.

If your device modifies a critical characteristic that affects performance or safety, Article 61(10) may not apply. The modification must be justified. If the justification introduces uncertainty, you need new clinical data.

In these situations, you either conduct a clinical investigation or you gather additional clinical data through other means. Post-market data from predicate devices, registries, real-world evidence studies.

But you do not skip the data requirement.

What Reviewers Look For

When a Notified Body reviews a submission invoking Article 61(10), they look for consistency between the claim and the evidence.

They check whether the justification for not conducting a clinical investigation is coherent with the device risk class, the novelty, and the clinical claims.

They assess whether the equivalence demonstration is complete. They look at the comparison table. They verify whether differences are adequately addressed.

They examine whether the clinical data from equivalent devices is sufficient. They check the literature search strategy, the appraisal methodology, the relevance of the studies.

They ask whether the manufacturer would reach the same conclusions if they were defending the device in a clinical setting. If the answer is uncertain, they issue a deficiency.

The most common deficiency I see is incomplete equivalence. The manufacturer states equivalence but does not provide enough detail to verify it. The table is superficial. The data from equivalent devices is not cited. The gap analysis is missing.

The second most common deficiency is insufficient clinical background. The manufacturer assumes the technology is established without demonstrating it. They do not cite enough clinical evidence. They do not explain why the performance is predictable.

Both deficiencies stem from the same misunderstanding. The belief that Article 61(10) reduces the burden of proof. It does not. It redirects it.

How This Connects to PMCF

Even when Article 61(10) applies, PMCF remains mandatory. You still need a post-market clinical follow-up plan. You still need to collect real-world evidence.

The PMCF objectives shift slightly. You focus on confirming that the assumptions you made during the clinical evaluation hold true in practice. You verify that the device performs as expected. You monitor for any deviations from the predicted clinical behavior.

This is particularly important when you rely on equivalence. You must confirm that your device behaves like the equivalent devices. If differences emerge, you update the clinical evaluation and reassess whether Article 61(10) still applies.

PMCF is not a formality. It is the mechanism that validates your initial reasoning.

Final Thoughts

Article 61(10) is not a shortcut. It is a structured path for devices where the clinical performance can be reliably anticipated based on established knowledge and equivalent device data.

The work does not disappear. The clinical evaluation report must be complete, rigorous, and defensible. The equivalence demonstration must be detailed. The clinical data appraisal must meet the same standards as any other submission.

What changes is the source of the evidence. You rely on existing knowledge rather than generating new data. But the reasoning, the justification, and the documentation remain equally demanding.

If you cannot meet the three conditions—established solutions, full equivalence, and adequate existing data—then Article 61(10) does not apply. You need clinical investigation or alternative clinical data sources.

And even when it does apply, remember that reviewers will scrutinize your reasoning. They will challenge incomplete equivalence. They will question unsupported assumptions. They will ask for evidence.

Because no clinical data does not mean no clinical evaluation. It means the evaluation must rely on something solid enough to stand on its own.

And if it does not, the submission will not pass.

Peace,
Hatem
Clinical Evaluation Expert for Medical Devices
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