Your medical device technical documentation is under review by a Notified Body. During the assessment, the assessor focuses on your Clinical Evaluation Report (CER).
The assessor raises a concern:
“You are relying entirely on a literature review. Please justify why your own clinical data are not required and explain how the cited literature sufficiently demonstrates the safety and performance of your device.”
For many manufacturers, this scenario is no longer hypothetical. Under today’s regulatory expectations, especially in Europe, reliance on published literature without strong justification is increasingly viewed as a regulatory risk rather than a safe default.
Literature Under EU MDR: Expectations Have Changed
The EU Medical Device Regulation (MDR) significantly raised the bar for clinical evaluation. Clinical evidence is no longer assessed as a one-time documentation exercise completed for conformity assessment. Instead, regulators now expect a continuous, risk-based clinical evaluation process that evolves throughout the device lifecycle.
A literature-only approach may still be acceptable but only when it is clearly justified, device-specific, and supported by structured analysis. Regulators expect manufacturers to demonstrate that the literature directly addresses the device’s intended purpose, safety risks, performance claims, and post-market obligations.
Simply collecting and summarising publications is no longer sufficient.
Clinical Data vs. Clinical Evidence: A Critical Difference
A common misunderstanding in clinical evaluation lies in confusing clinical data with clinical evidence.
- Clinical data refers to raw information obtained from scientific literature, clinical investigations, or post-market experience.
- Clinical evidence is created only after that data has been analysed, evaluated, and linked to the device’s specific safety and performance requirements.
A literature review is a way to gather data but without structured analysis and justification, it does not automatically become clinical evidence. When links to risk management, intended use, and performance claims are weak or assumed, the entire clinical evaluation becomes vulnerable to regulatory challenge.
When can a literature-only approach be acceptable?
In limited cases, a literature-based CER may still be justified. This typically applies when:
- The device uses well-established technology
- The risk profile is low and acceptable
- The intended claims are limited and well supported by existing scientific knowledge
Even in these cases, justification is critical. Manufacturers must clearly explain:
- Why the available literature is sufficient, and
- Why new clinical data are not required.
This justification is often the first element reviewed and questioned by assessor/auditors.
Common Regulatory Red Flags in Literature-Based Clinical Evaluation
Red Flag #1: Weak or Unjustified Equivalence Claims
Claiming equivalence based solely on publicly available literature is one of the most frequent causes of non-conformities. Regulators expect access to detailed technical, biological, and clinical information of the equivalent device.
Public sources such as journal articles or Instructions for Use rarely provide enough information on design, materials, or performance characteristics. Without access to this information, assessors or auditors may determine that equivalence cannot be demonstrated, undermining the entire literature-based strategy.
Red Flag #2: Literature that does not address residual risks
clinical evaluation must explicitly address residual risks identified through risk management. A common mistake is presenting general safety literature without mapping findings to device-specific risks.
Assessor/Auditors routinely check traceability between risks, clinical evidence, and conclusions. If the literature does not clearly demonstrate the acceptability of residual risks, the clinical evaluation is considered incomplete.
Red Flag #3: Inadequate or Outdated State-of-the-Art Analysis
State-of-the-art is not a high-level overview of disease management. It must reflect current clinical practice, alternative technologies, and applicable standards.
Reliance on outdated publications or superficial comparisons weakens benefit–risk conclusions and raises concerns about clinical relevance.
Red Flag #4: Missing or Poorly Justified PMCF Rationale
Post-Market Clinical Follow-up (PMCF) is now the default regulatory expectation. If a manufacturer concludes that PMCF is not required, this decision must be scientifically and clinically justified.
Statements such as “PMCF not applicable” without evidence-based reasoning are clear red flags and frequently lead to mandatory PMCF requests from regulators.
Red Flag #5: Mismatch Between Claims and Supporting Evidence
All claims whether in the Intended Use, IFU, or marketing materials must be supported by the clinical evaluation.
Literature may support general safety or performance, but not necessarily enhanced or device-specific claims. Any discrepancy between claims and evidence is a common audit observation and often results in requests for additional clinical data.
Conclusion: Literature Is a Tool, Not the Outcome
Literature remains a valuable component of clinical evaluation but it is only one part of the evidence-generation process. Regulatory success depends on transforming literature into device-specific clinical evidence through structured analysis, transparent justification, and strong traceability.
Regulators are not assessing how much literature has been reviewed. They are assessing how convincingly its relevance to the device has been demonstrated.
A robust clinical evaluation reflects regulatory maturity by anticipating scrutiny, combining clinical and risk considerations, and using clear justification as evidence.
Reference:
MDCG 2020‑5 Clinical Evaluation – Equivalence (EU MDR)
MDCG 2020‑6 Guidance on Sufficient Clinical Evidence for MDR
