Explant Analysis: The Evidence Reviewers Expect You to Have
I see it in nearly every submission for implantable devices: well-structured clinical evaluation reports, complete literature searches, post-market surveillance plans—but when I reach the section on explant analysis, there is nothing. Or worse, a single paragraph stating that no explants have been retrieved. For reviewers and Notified Bodies, this is not a minor omission. It signals that the manufacturer does not understand how long-term device performance is actually validated.
In This Article
The expectation is clear in MDCG 2020-6. For implantable devices, explant analysis is not optional. It is a fundamental component of post-market clinical follow-up and clinical evaluation. Yet many manufacturers treat it as something they will address if an explant happens to become available.
This reactive posture creates serious gaps in your clinical evidence.
Why Explant Analysis Matters for Implantable Devices
When a device is implanted, direct observation stops. You lose visibility into what is happening inside the body. Clinical follow-up gives you symptoms, imaging, and patient-reported outcomes. But these are indirect signals.
Explant analysis is the only method that allows direct examination of how the device has performed in the biological environment over time.
You see material degradation. You see tissue response at the interface. You see mechanical failure modes that were not predicted in bench testing. You see corrosion patterns, wear debris, fracture surfaces, and cellular infiltration.
This is not theoretical evidence. This is physical reality.
Explant analysis reveals failure modes and degradation patterns that cannot be detected through clinical follow-up alone. For reviewers, the absence of explant data raises the question: how do you know your device is performing as intended over its entire functional life?
What MDCG 2020-6 Actually Requires
MDCG 2020-6 addresses post-market clinical follow-up for implantable devices. It explicitly states that manufacturers should establish procedures for systematic explant retrieval and analysis.
The guidance is not vague. It describes what should be analyzed, how the data should be documented, and how findings should feed back into risk management and clinical evaluation.
But here is where the gap opens.
Many manufacturers read the guidance and conclude that explant analysis only applies when devices are removed for medical reasons. They wait for voluntary returns. They assume that if no patient has experienced a complication requiring explant, then no analysis is needed.
This interpretation misses the regulatory expectation entirely.
The Difference Between Reactive and Systematic Explant Analysis
Reactive explant analysis happens when a device is removed due to adverse events, patient request, or revision surgery. You receive the device, analyze it, document findings, and update your clinical evaluation report.
Systematic explant analysis is proactive. You establish processes to retrieve explants even when no adverse event has occurred. You collaborate with clinical sites to obtain devices removed during routine procedures or after the patient’s death. You plan retrieval during clinical investigations.
Notified Bodies expect the systematic approach. They want to see that you are actively seeking explant evidence, not passively waiting for problems to surface.
Clinical evaluation reports state
Frequently Asked Questions
What is a Clinical Evaluation Report (CER)?
A CER is a mandatory document under MDR 2017/745 that demonstrates the safety and performance of a medical device through systematic analysis of clinical data. It must be updated throughout the device lifecycle based on PMCF findings.
How often should the CER be updated?
The CER should be updated whenever significant new clinical data becomes available, after PMCF activities, when there are changes to the device or intended purpose, and at minimum during annual reviews as part of post-market surveillance.
What causes CER rejection by Notified Bodies?
Common reasons include inadequate equivalence demonstration, insufficient clinical data for claims, poorly structured SOTA analysis, missing gap analysis, and lack of clear benefit-risk determination. Structure and logical flow are as important as the data itself.
Which MDCG guidance documents are most relevant for clinical evaluation?
Key documents include MDCG 2020-5 (Equivalence), MDCG 2020-6 (Sufficient Clinical Evidence), MDCG 2020-13 (CEAR Template), MDCG 2020-7 (PMCF Plan), and MDCG 2020-8 (PMCF Evaluation Report). MDCG 2020-6
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Read Complete Guide to Clinical Evaluation under EU MDR for a comprehensive overview of clinical evaluation under EU MDR 2017/745.
