In the world of medical devices under EU MDR (EU 2017/745), the clinical evaluation process is a cornerstone of demonstrating safety and performance. At its heart are two interlinked documents: the Clinical Evaluation Plan (CEP) – which defines how you’ll gather and assess clinical evidence – and the Clinical Evaluation Report (CER) – which presents the conclusions. A strong CEP, especially its literature search, appraisal methodology, and state-of-the-art (SOTA) analysis, is critical to building a robust CER that stands up under scrutiny.
In this post, I’ll walk through what makes a CEP rigorous, how that feeds into the CER, and what evolving regulatory expectations you should watch for.
What is CEP, and Why It Matters
The CEP acts like the blueprint for your clinical evaluation. It establishes:
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The scope of what the clinical evaluation will cover (device variants, indications, populations)
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The methodology and strategy for gathering data – e.g. sources beyond your internal trials, including literature, registries, post-market data
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Criteria for appraising data (quality, relevance, bias)
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Benchmarks and comparators grounded in the SOTA
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How you will integrate or justify gaps or conflicting data
Starting with a well-defined CEP ensures that your CER isn’t built piecemeal, but as a coherent, defensible narrative. The CEP also helps you preempt challenges during audits or Notified Body review by making decisions transparent: why you searched where you did, how you judged inclusion/exclusion, and how you will reconcile data.
Recent guidance emphasizes that the CEP must define the comparison to state-of-the-art devices or practices, and the performance/safety benchmarks used.
The Role of Literature Search, Appraisal & State-of-the-Art Analysis
These three elements are the foundation of a defensible clinical evaluation. You’ll see them woven through CEP and CER:
Literature Search: Methodical, Transparent, Systematic
A credible literature search is not optional. Under MDR and its guidance, you must:
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Define search objectives and protocol up front, including databases, keywords, inclusion/exclusion criteria, timeframes, and how to handle duplicates or grey literature.
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Perform searches in multiple categories: (a) your device (or equivalent) evidence, (b) state-of-the-art devices or therapies, and sometimes (c) broader medical background or alternative interventions.
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Document every step: protocol, deviations, search results, full texts, excluded studies with reasons — so reviewers can reproduce or audit your process.
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Be objective — include unfavorable findings and handle bias transparently.
Because the literature search feeds the rest of your evaluation, if it’s weak or poorly documented, the remainder (appraisal, conclusions) is vulnerable.
Appraisal: Evaluating Relevance, Methodology & Weight
Once candidate studies or data sources are gathered, you need a plan to judge them:
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Create an appraisal plan, documented in your CEP, which defines the criteria (methodological quality, bias risk, relevance to your device/indication)
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Apply the plan uniformly — rank or weigh data sources based on strength and relevance, not just favorable outcomes.
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Use full-text publications (not abstracts) wherever possible, to fully understand context, limitations, and data detail.
A transparent appraisal process builds trust: reviewers can see why you accepted or rejected a data set, and how it contributes to your conclusions.
State-of-the-Art (SOTA) Analysis: Benchmarking Your Device
State-of-the-Art is more than a buzzword – it’s required by MDR. Your device’s safety, performance, and benefit-risk must be judged in context of existing technologies, therapies, and clinical practices.
Key roles of SOTA analysis:
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Define benchmarks against which your device’s performance and safety will be compared – e.g. complication rates, clinical outcomes of alternative therapies.
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Influence your choice of endpoints and acceptance thresholds in CEP.
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Provide critical comparators in the CER: how does your device stack up?
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Help explain residual risks and set acceptable margins in justification of benefit-risk.
Regulators expect your SOTA discussion to be explicit, well referenced, and woven into your clinical claims and comparisons.
From CEP to CER: How the Pieces Connect
A CEP built around a rigorous literature search and appraisal methodology leads into a CER that:
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Maps data to benchmarks and endpoints defined relative to SOTA
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Presents balanced risk-benefit conclusions, with rationale for gaps or uncertainties
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Integrates multiple evidence streams (your clinical studies, post-market data, literature)
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Provides traceability – you can show reviewer how each conclusion was reached, based on your documented methodology
Many Notified Bodies find recurring issues in CERs:
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Objectives or endpoints that are too vague (lack specific measurable objectives)
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Benchmarks not justified or not clearly tied to SOTA
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Literature searches not sufficiently documented or systematic
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Weak appraisal methodology leading to biased conclusions
So getting your CEP + literature + appraisal right reduces the chances of NB queries or rejections.
Wrapping Up: Why CEP & CER Are Strategic Tools Under MDR
With regulators putting increasing emphasis on systematic literature searches, rigorous appraisal, and clear state-of-the-art benchmarks, CEP and CER are no longer just compliance requirements – they’re strategic documents. They determine whether your device’s clinical evidence package is strong enough to withstand scrutiny or risks being sent back with questions, delays, or costly re-work.
At MDS, we help build CEPs and CERs that are methodologically sound, aligned with MDR’s General Safety and Performance Requirements, and designed to anticipate the issues Notified Bodies will raise. By combining regulatory expertise with robust clinical evaluation strategies, we ensure your documentation supports both market entry and long-term compliance.
📧 To learn more about how our services can support your CEP/CER strategy, contact us at sales@mdsfinland.com or schedule a consultation via Book a Meeting.
