The Ten CER Deficiencies That Delay Every Submission

Written by HATEM RABEH, MD, MSc Ing

Your Clinical Evaluation Expert And Partner

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What follows is not theory. These are the deficiencies I encounter most frequently in real submissions, along with the reasoning behind why they fail and how to prevent them. If you address these before submission, you eliminate most of the common causes of delay.

Deficiency 1: Intended Purpose Mismatch

The clinical evaluation addresses a different intended purpose than what appears in the IFU, labeling, or technical documentation. Sometimes the differences are subtle—a broader patient population in the CER than in the IFU, or clinical claims that exceed what the labeling states.

Reviewers compare documents. When your CER evaluates clinical evidence for indications not in your intended purpose, or misses indications that are, the entire evaluation becomes suspect. The fix is simple: align all documents before you start the clinical evaluation, not after.

Deficiency 2: State of the Art That Is Not Current

SOTA sections that cite outdated guidelines, miss recent pivotal studies, or ignore current treatment paradigms. Medical knowledge evolves. A SOTA written in 2022 may be outdated by 2024. If your SOTA does not reflect current clinical practice, reviewers question whether your entire evaluation is current.

The issue is not just currency—it is completeness. SOTA must include clinical guidelines, alternative treatments, safety benchmarks, and outcome expectations. Many CERs only address published literature on similar devices, missing the broader clinical context.

Deficiency 3: Literature Search That Cannot Be Reproduced

Search protocols with vague terms, missing databases, or incomplete date ranges. If another evaluator cannot reproduce your search and get similar results, your evidence base is indefensible. MDCG 2020-6 requires systematic, reproducible searches.

Common gaps: no search in regulatory databases like MAUDE or EUDAMED, no grey literature search, search terms that do not cover all relevant device types, missing MeSH terms or Boolean operators not documented.

Deficiency 4: Equivalence Without Contract

Claiming equivalence to a competitor device without the required contract to access their technical documentation. Under MDCG 2020-5, demonstrating equivalence requires access to sufficient information about the equivalent device. For competitor devices, this typically means a formal contract.

Many manufacturers assume they can establish equivalence from public information alone. For straightforward, well-documented devices, this might work. For complex devices or when technical details matter, it does not. If your equivalence depends on information you cannot access, your equivalence claim fails.

Deficiency 5: Clinical Data Without Appraisal

Including clinical data without assessing its quality, relevance, and contribution to the evaluation. Data inclusion is not data appraisal. Each study or data source should be evaluated for methodological quality, applicability to your device, and weight in your overall evidence synthesis.

Common mistakes: presenting study results without discussing limitations, treating all studies as equally reliable, not explaining why certain studies were weighted more heavily, missing conflicts of interest assessment.

Deficiency 6: Gap Analysis Missing or Generic

Either no gap analysis at all, or a generic statement that no gaps exist. If your evidence is complete and sufficient for all claims, explain why. If gaps exist, identify them specifically and explain how PMCF will address them.

Reviewers expect gaps. No clinical evaluation has perfect evidence for every claim. Pretending otherwise raises credibility concerns. A thoughtful gap analysis that acknowledges limitations and explains mitigation strategies is far stronger than an implausible claim of completeness.

Deficiency 7: Benefit-Risk Without Reasoning

Benefit-risk sections that list benefits and risks, then conclude benefits outweigh risks—without explaining why. The determination must follow logically from the analysis. If a reviewer cannot trace your reasoning, you have not demonstrated anything.

The fix: structure your benefit-risk as an argument, not a summary. State the benefits with quantification, characterize the risks with severity and probability, explain the comparison basis, then provide a reasoned conclusion that follows from the preceding analysis.

Deficiency 8: PMCF Plan Disconnected from CER

PMCF plans that do not address the gaps identified in the clinical evaluation, or clinical evaluations that do not reference what PMCF is designed to resolve. These documents must connect. If your CER identifies uncertainty about long-term outcomes, your PMCF should include activities to address that uncertainty.

Deficiency 9: Risk Management File Inconsistency

Clinical evaluation conclusions that contradict the risk management file. If your risk management identifies certain hazards as significant, your clinical evaluation should address them. If your clinical evaluation concludes certain risks are well-controlled, your risk management should reflect that.

These are not independent documents. They inform each other. Reviewers cross-reference. Inconsistencies suggest either outdated documents or inadequate coordination between teams.

Deficiency 10: Document Not Updated

CERs that have not been updated despite triggering events: new clinical data, design changes, safety signals, updated SOTA, or PMCF findings. MDR requires ongoing clinical evaluation. A CER dated 2022 with no updates despite market experience raises questions.

Establish update triggers and review cycles before you need them. Document your process. When reviews occur and find no updates needed, document that too. The goal is demonstrable ongoing evaluation, not just a static document.

Prevention Is Cheaper Than Correction

Every deficiency listed here is preventable with proper planning and process. The cost of addressing these issues before submission is a fraction of the cost of responding to findings, revising documents, and managing delayed approvals.

Use this list as a checklist before submission. Review your CER against each deficiency. Address gaps proactively. When reviewers find nothing to question, submissions move forward.

This concludes our series on mastering the clinical evaluation report. The principles are straightforward: build evidence systematically, argue logically, demonstrate rather than assert, and maintain alignment across your regulatory documentation. Do these consistently, and your CERs will stand up to scrutiny.

CER deficiencies cause costly rework and delays. Understand the financial impact in our guide to CE marking costs for medical devices.