One Device, Multiple Claims: Where Your CER Starts to Unravel

Written by HATEM RABEH, MD, MSc Ing

Your Clinical Evaluation Expert And Partner

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The regulatory logic is straightforward. Each intended purpose represents a different clinical claim. Each claim must be substantiated independently. But in practice, manufacturers often treat multiple intended purposes as variations of a single claim, building one appraisal that broadly covers everything.

This approach collapses under scrutiny.

Why Multiple Intended Purposes Create Evaluation Complexity

When a device has multiple intended purposes, you’re not just expanding the scope of your CER. You’re multiplying the evaluation requirements.

Each intended purpose must be supported by clinical data that directly addresses:

• The specific clinical condition or population
• The specific performance outcome expected
• The specific clinical benefit claimed
• The specific risks in that context

According to MDR Article 61 and Annex XIV, the clinical evaluation must demonstrate that the device achieves its intended performance for each stated purpose. This is not a technicality. It’s the foundation of the clinical claim.

Yet manufacturers routinely present a single clinical dataset and attempt to extrapolate it across multiple purposes without demonstrating that each purpose is clinically distinct or that the data actually applies to each one.

The Structural Problem in Most CERs

The typical pattern I encounter looks like this:

The manufacturer lists three intended purposes in the device description. The literature search is broad and captures studies across all purposes. The appraisal section evaluates studies without clearly mapping them to specific purposes. The analysis section presents overall safety and performance conclusions.

There’s no clear separation. No systematic demonstration that each purpose is supported independently.

The Notified Body reviewer reads through and realizes they cannot determine whether Purpose B is actually supported by clinical evidence, or whether it’s just assumed to be covered because Purpose A is demonstrated.

This leads to major non-conformities. And delays.

What Reviewers Are Looking For

When a Notified Body reviews a device with multiple intended purposes, they expect to see structure that reflects those distinctions.

This means:

• A clear definition of each intended purpose as a separate clinical claim
• A literature search strategy that targets each purpose
• An appraisal that maps studies to the specific purpose they support
• An analysis section with separate conclusions for each purpose
• A benefit-risk assessment that addresses each purpose independently

If this structure isn’t visible in your CER, the reviewer cannot verify that each claim is substantiated. They flag it.

The Risk of Bundling Claims Without Clinical Justification

Some manufacturers assume that if a device performs well for one purpose, it automatically performs well for related purposes. This assumption creates regulatory and clinical risk.

Consider a wound dressing indicated for both acute surgical wounds and chronic diabetic ulcers. These are two distinct clinical contexts with different:

• Healing mechanisms
• Patient populations
• Risk profiles
• Performance expectations

A study demonstrating efficacy in post-surgical wounds does not automatically validate the claim for diabetic ulcers. The pathophysiology is different. The clinical endpoints may differ. The duration of use may differ.

Without specific evidence for each purpose, you cannot claim both. Yet manufacturers often do, relying on general statements about wound healing rather than targeted clinical data.

What Happens During Notified Body Review

The reviewer goes through your intended purposes one by one. They check whether each purpose is supported by at least some direct clinical evidence or a clearly justified equivalence pathway.

If Purpose A has five studies but Purpose B has none, they will ask for clinical data or a rationale for why Purpose B can be considered equivalent or derivative.

If you cannot provide that rationale, you must either remove Purpose B from your claims or conduct additional clinical investigations.

This is not theoretical. I’ve worked with manufacturers who had to remove intended purposes from their labeling because the clinical evaluation could not support them.

How to Structure a CER for Multiple Intended Purposes

The solution is methodical separation and clear mapping throughout the CER.

Start by defining each intended purpose as a distinct clinical claim in your scope section. Be explicit about what is being claimed for each purpose:

• What clinical condition or situation?
• What patient population?
• What expected outcome or benefit?
• What duration or context of use?

Then structure your literature search to address each purpose. This may require multiple search strategies or subgroup analyses within a broader search.

In your appraisal section, clearly indicate which studies support which purposes. Use a matrix or table if necessary to map studies to claims.

In your analysis, provide separate sections for each intended purpose. Each section should present:

• The clinical data supporting that purpose
• The performance outcomes relevant to that purpose
• The safety profile in that context
• The benefit-risk conclusion for that purpose

If you claim equivalence for one of the purposes, provide a clear equivalence justification specific to that purpose.

When Clinical Investigations Become Necessary

If one or more of your intended purposes cannot be substantiated through literature or equivalence, you will need clinical investigation data.

This is particularly common when:

• A new intended purpose is added to an existing device
• One purpose involves a higher-risk population or condition
• The purposes involve different mechanisms of action or performance expectations

The clinical investigation must be designed to generate data specific to the unsupported purpose. A general clinical study that lumps all purposes together will not solve the problem.

I’ve reviewed CERs where manufacturers conducted a single clinical trial enrolling patients across all intended purposes but did not stratify or analyze results by purpose. This does not meet the requirement for purpose-specific evidence.

The PMCF Implications

Your post-market clinical follow-up plan must also reflect the multiple intended purposes. PMCF activities should generate data for each purpose, not just for the device in general.

This means your PMCF study design, registry participation, or surveillance methods must capture outcomes relevant to each purpose separately.

If your PMCF plan only monitors one primary use case, reviewers will ask how you’re confirming ongoing safety and performance for the other purposes.

According to MDCG 2020-7, PMCF is purpose-driven. It must address the specific clinical claims made in your CER. When those claims are multiple, your PMCF scope must reflect that multiplicity.

I’ve seen PMCF plans flagged because they described a single data collection approach without distinguishing between the device’s different intended purposes. The Notified Body requested separate data collection or at minimum subgroup analysis by purpose.

What This Means for Your Next Submission

If your device has multiple intended purposes, review your current CER structure. Ask yourself:

• Can a reviewer clearly identify which evidence supports which purpose?
• Are there separate conclusions for each purpose?
• Is each purpose independently substantiated, or are some implied?
• Does your PMCF plan address all purposes?

If the answers are unclear, you need to restructure before submission. This is not about adding more pages. It’s about making explicit what is currently implicit.

Multiple intended purposes are not a problem. They’re a regulatory reality. But they require disciplined structure in your clinical evaluation. Without that structure, your CER will not survive review.

The devices that pass efficiently are the ones where every claim is traceable to specific evidence, and every intended purpose has its own clinical justification.

That clarity is what Notified Bodies are looking for. And it’s what your clinical evaluation should deliver.

Peace,
Hatem
Clinical Evaluation Expert for Medical Devices
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