Why your legacy device evidence looks weaker every year

Written by HATEM RABEH, MD, MSc Ing

Your Clinical Evaluation Expert And Partner

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I’ve reviewed dozens of Technical Documentation submissions for legacy devices that have been on the market for ten, fifteen, sometimes twenty years. The clinical evidence sections often include studies from the 1990s, scattered case reports, and a declaration that the device has a long history of safe use.

The problem is this: history alone doesn’t fulfill MDR requirements.

MDCG 2020-6 was published specifically to clarify what constitutes sufficient clinical evidence for legacy devices. It addresses one of the most misunderstood transitions under MDR: how to bring older devices into compliance when the evidentiary standards have fundamentally changed.

Let me walk through what this guidance actually demands, why most submissions fall short, and what you need to do differently.

The Core Misconception About Legacy Devices

Many regulatory teams operate under the assumption that a device with a long market history requires less clinical evidence. The reasoning goes: if it’s been used safely for years, that should count for something.

It does count. But not in the way you think.

MDR Article 61 and Annex XIV make no distinction between new devices and legacy devices regarding the depth of clinical evaluation required. The requirement is the same: demonstrate safety and performance based on sufficient clinical evidence that reflects the current state of the art.

MDCG 2020-6 acknowledges that legacy devices may have existing clinical data. But it also makes clear that this data must be assessed against present standards, not the standards that existed when the device was first cleared.

This is where the gap appears. The data you have may be real. But if it no longer reflects how the device is used today, or if newer alternatives have shifted the benefit-risk profile, your evidence base is incomplete.

What MDCG 2020-6 Actually Requires

The guidance is structured around a simple principle: sufficient clinical evidence is not a static concept. It evolves as medical knowledge evolves.

For legacy devices, this means three things:

First: Conduct a gap analysis. Compare your existing clinical data against current SOTA. Identify what’s missing. Identify what’s outdated. Identify what assumptions are no longer valid.

This isn’t a checkbox exercise. It’s a systematic evaluation of whether your evidence would satisfy a reviewer who has just read the latest meta-analyses, guidelines, and competitor data.

Second: Supplement where necessary. If the gap analysis reveals deficiencies, you must generate new data. That could mean clinical investigations, but more commonly it means literature reviews, PMCF studies, or real-world evidence collection.

MDCG 2020-6 explicitly states that historical data can be valid if it remains relevant. But relevance must be argued, not assumed.

Third: Maintain ongoing surveillance. Legacy devices are not exempt from post-market obligations. In fact, they often require more intensive PMCF because their pre-market evidence base is older and less aligned with current practice.

The SOTA Problem for Legacy Devices

State of the art is the single biggest challenge for legacy devices under MDR.

When your device was first developed, the SOTA was different. Treatment options were different. Outcome measures were different. Standards of care were different.

Now you must evaluate your device against today’s SOTA. That includes:

– Current clinical guidelines and treatment algorithms
– Newer devices in the same category or therapeutic area
– Updated safety thresholds and performance benchmarks
– Evolving patient populations and use conditions

Here’s what happens in practice: a manufacturer submits a Clinical Evaluation Report that references studies from 2005. The device is a Class IIb implant. The literature review stops at 2018. The SOTA analysis is two paragraphs.

The Notified Body asks: why does your SOTA section not address the three competing devices launched since 2019? Why does it not reference the updated clinical guidelines from 2021? Why does your safety profile not account for the new adverse event categories identified in recent registries?

The manufacturer has no answer, because the SOTA analysis was treated as a formality rather than a rigorous evaluation.

MDCG 2020-6 is clear: you must show that your device still represents an acceptable option within the current landscape. That means comparing it to current alternatives, not just to older versions of itself.

How to Structure Evidence for a Legacy Device

Let’s get practical. You have a legacy device. You need to demonstrate sufficient clinical evidence. What does that look like?

Step 1: Document the device’s full history.

Collect all pre-market clinical data: studies, reports, technical documentation from the original submission. Then collect all post-market data: vigilance reports, complaint trends, PMCF outputs, field safety notices.

This gives you the baseline. Now you know what evidence exists.

Step 2: Conduct a comprehensive literature review.

This review must be systematic, cover recent publications, and include competitor data. It must address the device’s specific intended use, patient population, and claims.

The literature review serves two purposes: it updates your understanding of SOTA, and it may provide appraisal data if the device or equivalent devices have been studied independently.

Step 3: Perform the gap analysis.

Map your existing data against MDR Annex XIV requirements and the current SOTA. Identify gaps in safety data, performance data, long-term outcomes, specific patient subgroups, or specific use conditions.

Be honest. If you claim there are no gaps, you will be challenged.

Step 4: Generate a plan to close gaps.

Where gaps exist, outline how you will address them. That might be a PMCF study, a registry, a literature-based appraisal, or a clinical investigation.

MDCG 2020-6 allows for various data sources. What it doesn’t allow is ignoring gaps.

Step 5: Establish continuous PMCF.

Your PMCF plan should actively monitor whether the device’s clinical profile remains consistent with the evidence you submitted. For legacy devices, this means tracking not just safety signals but also whether clinical practice or SOTA has shifted in ways that affect the device’s role.

What Reviewers Look For

I’ve sat in meetings where Notified Bodies and competent authorities review legacy device files. The questions they ask are predictable:

– Has the manufacturer demonstrated awareness of current SOTA?
– Is the existing clinical data still applicable given changes in practice?
– Are there safety or performance concerns that were acceptable in the past but no longer meet current thresholds?
– Is the PMCF plan robust enough to detect shifts in the benefit-risk profile?

They are not looking for perfection. They are looking for rigor and transparency.

If you present a gap analysis that honestly identifies weaknesses and commits to addressing them, that is acceptable. If you present a file that pretends no gaps exist, that will be rejected.

The difference is credibility.

Why This Matters More Every Year

Every year your legacy device remains on the market without updated evidence, the gap between your file and current expectations grows.

New studies are published. New devices are launched. New guidelines are released. New adverse events are identified in post-market data for similar devices.

MDCG 2020-6 recognizes this. It doesn’t ask you to redo everything from scratch. But it does ask you to prove that your understanding of the device’s clinical profile is current, not frozen in the year the device was originally cleared.

This is not a one-time exercise. It’s an ongoing obligation.

If your Clinical Evaluation Report hasn’t been substantially updated in three years, you are behind. If your PMCF plan is generating reports that don’t feed back into the CER, you are not closing the loop.

Final Considerations

MDCG 2020-6 is not a relaxation of standards for legacy devices. It’s a roadmap for bringing them into compliance with the same evidentiary rigor expected of new devices.

The manufacturers who succeed are the ones who recognize that legacy status is not a shield. It’s a starting point.

Your device may have been on the market for twenty years. That experience is valuable. But it must be translated into evidence that meets today’s standards, not yesterday’s.

The longer you delay that work, the more difficult it becomes. Because the gap only widens.

If your legacy device file is still relying on studies older than ten years without a clear SOTA justification for why they remain valid, you have work to do. Start with the gap analysis. Be honest about what’s missing. Then build the plan to close it.

That’s how you demonstrate sufficient clinical evidence under MDR. Not by defending the past, but by proving the present.

Peace,
Hatem
Clinical Evaluation Expert for Medical Devices
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