Why Your Legacy Device Might Not Survive MDR Transition

Written by HATEM RABEH, MD, MSc Ing

Your Clinical Evaluation Expert And Partner

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Legacy devices represent a specific challenge under MDR. These are not new products entering the market. They are established devices transitioning from directives to regulation. The problem is that what was acceptable evidence under MDD or AIMDD often falls short under MDR Article 61 and Annex XIV.

The mistake I see repeatedly is treating MDR transition as a documentation update. Manufacturers believe they can take the existing technical file, add a few paragraphs about conformity, and call it done. That approach fails during Notified Body assessment.

The reason it fails is not arbitrary. MDR changed the definition of sufficient clinical evidence. What your device demonstrated in 2005 or 2012 may have been adequate then. But MDR expects you to prove that your device still meets the general safety and performance requirements using current data, current methodologies, and current standards of analysis.

What Makes a Device Legacy

A legacy device is one that was legally placed on the market under previous directives and is transitioning to MDR. It is not a new device. It is not a significantly modified device. It has a history of clinical use.

That history matters, but not in the way most manufacturers think. Having years of market presence does not exempt you from MDR clinical evaluation requirements. It gives you data to work with. But you must analyze that data according to MDR standards.

The issue is that many legacy devices were cleared with limited clinical data. Under MDD, equivalence to a predicate device or bibliographic literature combined with performance testing was often sufficient. MDR tightens both the rigor and the scope of what counts as adequate evidence.

The Evidence Gap for Legacy Devices

Most legacy devices face an evidence gap. This gap is not about whether the device works. It is about whether the available evidence proves the device works according to the requirements in Annex I of MDR.

Let me be specific. Your legacy device may have been on the market for fifteen years. During that time, it accumulated post-market surveillance data, vigilance reports, customer feedback, and perhaps some publications. That evidence tells you about adverse events, complaint rates, and user satisfaction.

What it often does not tell you is whether the device achieves its intended clinical benefit as stated in its current intended purpose. It may not tell you how it performs against the current state of the art. It may not address all the risks identified in the current risk management file. And it almost certainly does not address the clinical safety and performance in the way MDR Annex XIV Part A describes.

This is where manufacturers encounter Notified Body major findings. The finding is not that the device is unsafe. The finding is that the clinical evaluation does not demonstrate compliance with MDR requirements using acceptable evidence.

State of the Art as a Moving Target

One of the hardest parts of legacy device evaluation is addressing the state of the art. When your device was first cleared, it was compared to what existed at that time. The state of the art has moved since then.

MDR Article 61(1) requires that devices provide a high level of protection of health and safety and perform as intended. This must be demonstrated by comparison to the current state of the art, not the state of the art when the device was first approved.

I have seen clinical evaluation reports that describe the device’s original design rationale and original clinical testing. Then they jump directly to current post-market data. What is missing is a systematic analysis of how the device compares to current alternatives, current treatment approaches, and current clinical guidelines.

This comparison is not optional. MDCG 2020-5 and MDCG 2020-6 both emphasize that the state of the art must be defined and that your device must be evaluated against it. For a legacy device, this often means confronting the fact that newer technologies or methods exist.

The question is not whether your device is obsolete. The question is whether it still provides acceptable clinical performance and safety when compared to what is available today. If it does, you must demonstrate that with data. If it does not, you must explain why continued use is justified or consider design improvements.

Can You Use Equivalence for Legacy Devices?

Equivalence is a common strategy for legacy devices. The logic seems straightforward. My device has been on the market for years. I will demonstrate equivalence to my own earlier version or to a similar device that has strong clinical data.

This approach can work, but only if the equivalence claim is valid under MDR standards. MDR raised the bar significantly for equivalence. The devices must be technically, biologically, and clinically equivalent. You must have access to the data from the equivalent device. And you must demonstrate that any differences do not negatively affect safety or performance.

For legacy devices, the problem is often that the original predicate device no longer meets MDR evidence requirements either. You are trying to demonstrate equivalence to something that itself would not pass MDR scrutiny if reviewed today. That creates a circular problem.

I also see manufacturers attempting to claim equivalence to their own legacy device as it existed ten years ago. But if the current device has undergone modifications, updates, or design changes over those ten years, the equivalence claim may not hold. Each change must be analyzed for its impact on clinical safety and performance.

Post-Market Data as Core Evidence

Post-market data is the strongest asset for legacy devices. This is data you cannot have for a new device. It includes real-world performance, long-term safety, complaint trends, return rates, and clinical outcomes observed during routine use.

But post-market data must be actively collected, analyzed, and presented in a structured way. Many legacy device files contain vigilance reports and complaint logs. What they lack is a systematic clinical evaluation of that data.

MDCG 2020-8 describes how post-market clinical follow-up (PMCF) should be conducted. For legacy devices, PMCF is not just future monitoring. It is also retrospective analysis of existing data. You must go back through your records and extract clinically meaningful information.

This means reviewing complaints not just for regulatory reportability, but for patterns that might indicate performance issues. It means analyzing return rates and correlating them with specific patient populations or use conditions. It means identifying whether any adverse events suggest a risk that was underestimated in the original risk analysis.

If you do this correctly, post-market data becomes the backbone of your clinical evaluation. It demonstrates that the device performs as intended in real-world use. It shows that risks are controlled. And it provides evidence that the benefit-risk ratio remains favorable.

If you do not do this correctly, your post-market data is just a pile of reports that Notified Bodies will see as insufficient.

Filling the Gaps Without New Clinical Investigations

Most manufacturers of legacy devices want to avoid new clinical investigations. They are expensive, time-consuming, and difficult to justify for a device already in use. The question is whether you can generate sufficient evidence without them.

The answer depends on your existing evidence base and the magnitude of the gaps. If your gaps are small and relate to specific populations or use conditions not well covered in your data, a targeted PMCF study may suffice. This could be a registry, a survey, or a retrospective chart review.

If your gaps are large and relate to fundamental questions about clinical benefit or safety, a clinical investigation may be unavoidable. I have seen manufacturers try to avoid this by relying on literature, but literature only works if it is directly applicable to your device and your intended use. Generic literature about the treatment area is not enough.

Another strategy is to conduct a gap analysis early. Map your available evidence against MDR Annex XIV requirements. Identify what is strong and what is weak. Then determine the most efficient way to close each gap. Sometimes it is additional data collection. Sometimes it is re-analysis of existing data using more rigorous methods. Sometimes it is commissioning a targeted study.

What does not work is hoping the Notified Body will accept what you have because your device has been on the market for a long time. They will not.

The Role of the Notified Body in Legacy Device Review

Notified Bodies understand that legacy devices have constraints. They know you cannot go back in time and run studies that were not required then. But they also have no discretion to waive MDR requirements.

What I observe in reviews is that Notified Bodies focus on whether you have made a reasonable effort to generate sufficient evidence given the constraints. They assess whether your clinical evaluation is honest about what you know and what you do not know. They evaluate whether your PMCF plan is designed to address real gaps or whether it is a generic placeholder.

If your clinical evaluation acknowledges evidence gaps, explains why those gaps exist, and presents a credible plan to close them, Notified Bodies are often willing to work with you. If your evaluation pretends gaps do not exist or dismisses concerns without justification, you will face major findings.

The review process for legacy devices can be longer because Notified Bodies must evaluate whether historical evidence translates to MDR compliance. Be prepared for questions about data quality, relevance of old studies, and adequacy of post-market surveillance systems.

Practical Steps for Legacy Device Clinical Evaluation

Start by acknowledging what you are working with. You have a device with history. That history includes evidence, but it may not be organized or analyzed according to MDR standards. Your task is to transform that historical record into a compliant clinical evaluation.

First, compile all available clinical data. This includes pre-market studies, post-market surveillance records, complaint data, vigilance reports, literature, and any real-world evidence you have collected. Organize it by type and evaluate its quality.

Second, conduct a gap analysis. Compare your evidence against the requirements in MDR Annex XIV Part A. Identify where you have strong evidence and where you have weak or missing evidence. Be honest in this assessment.

Third, define your state of the art. Research current alternatives, current clinical guidelines, and current treatment standards for your intended use. Explain how your device compares. If it is not the newest technology, explain why it remains clinically acceptable.

Fourth, analyze your post-market data systematically. Do not just summarize complaint counts. Evaluate trends, root causes, and clinical implications. Demonstrate that you have learned from real-world use and that your device performs as intended.

Fifth, develop a credible PMCF plan. If you have evidence gaps, your PMCF plan must address them with specific activities, timelines, and success criteria. Generic plans do not satisfy Notified Bodies.

Finally, write a clinical evaluation report that presents your evidence, your analysis, and your conclusions in a logical, transparent way. The report must show that you have systematically evaluated compliance with MDR requirements and that you have addressed or are addressing any deficiencies.

When Legacy Devices Cannot Transition

Not all legacy devices will make it through MDR transition. Some devices were approved under standards that are no longer acceptable. Some have evidence bases that cannot be reconstructed or supplemented. Some are obsolete compared to current alternatives.

If your clinical evaluation reveals that you cannot generate sufficient evidence to demonstrate MDR compliance, you have a decision to make. You can invest in additional studies, modify the device, or withdraw it from the market.

This is not a failure of the regulatory system. It is the system working as intended. MDR set a higher bar because patient safety and clinical performance are non-negotiable. Devices that cannot meet that bar should not remain on the market.

I have worked with manufacturers who made the difficult decision to discontinue legacy products because the cost and time required to generate compliant evidence was not justified by the product’s market position. That is a business decision, but it is informed by a clear-eyed assessment of regulatory reality.

What you cannot do is pretend the requirements do not apply to you because your device is old. They do. And Notified Bodies will enforce them.

Legacy devices face a unique challenge under MDR. They must prove they meet current requirements using evidence that may be years or decades old. The pathway is not impossible, but it requires systematic effort, honest assessment, and often additional data generation.

Your legacy device’s survival depends not on how long it has been on the market, but on whether you can demonstrate that it still meets the standard MDR demands. That demonstration requires work. But for devices that truly provide clinical value, that work is worth doing.

Peace,
Hatem
Clinical Evaluation Expert for Medical Devices
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