Clinical Evaluation Plan (CEP) under EU MDR 2017/745
The Clinical Evaluation Plan is the strategic foundation document that defines the scope, methodology, and acceptance criteria for your entire clinical evaluation. Without a well-structured CEP, your Clinical Evaluation Report lacks direction. and your Notified Body review lacks confidence.
What Is a Clinical Evaluation Plan?
A Clinical Evaluation Plan (CEP) is a mandatory planning document required under EU MDR 2017/745, Annex XIV Part A. It defines the scope, objectives, and methodology of the clinical evaluation process before any data collection or analysis begins. The CEP establishes what clinical evidence is needed, how it will be identified and appraised, and what acceptance criteria will be used to determine whether the device achieves its intended purpose with an acceptable benefit-risk profile.
The CEP is the starting point of the clinical evaluation lifecycle. It directly governs the content and structure of the Clinical Evaluation Report (CER), informs the design of the State of the Art (SOTA) analysis, and establishes the framework for ongoing Post-Market Clinical Follow-up (PMCF) activities. A CER that does not trace back to a clearly defined CEP is a CER that will fail Notified Body review.
Think of the CEP as the protocol for your clinical evaluation. Just as a clinical investigation cannot proceed without a clinical investigation plan (CIP), a clinical evaluation cannot be considered methodologically sound without a documented CEP that predetermines the approach. This is not optional. it is a regulatory expectation embedded in the MDR text and reinforced by every relevant MDCG guidance document.
When Is a CEP Required?
A CEP is required for every medical device that undergoes clinical evaluation under the MDR. which means every device placed on the EU market, regardless of classification. There is no exemption from the obligation to plan the clinical evaluation, even if the depth and complexity of the plan may vary by device class and risk profile.
- Class III and implantable devices The CEP must be highly detailed, specifying the clinical investigation strategy (or the equivalence pathway), the literature search protocol with predefined databases and search strings, quantified acceptance criteria for each clinical claim, and a comprehensive PMCF strategy. Notified Bodies will scrutinize every element of the plan against MDCG 2020-13 expectations.
- Class IIb and IIa devices The CEP should define the equivalence approach (if applicable), the literature search methodology, the SOTA framework, and the criteria for determining sufficient clinical evidence. The level of detail should be proportionate to the device’s novelty, intended purpose, and residual risk profile.
- Class I devices Even under Article 61(10), manufacturers must document a CEP that identifies the relevant benefit-risk parameters and defines how the clinical evaluation will be conducted. The plan may be shorter, but it must exist and must demonstrate a systematic approach.
A common misconception is that Class I devices do not need a CEP. This is incorrect. MDR Annex XIV Part A applies universally. What changes is the depth of the plan and the volume of clinical evidence required. not the obligation to plan.
CEP Structure: What Every Plan Must Include
Based on MDR Annex XIV Part A, MDCG 2020-5, and MDCG 2020-13 guidance, a compliant CEP should include the following sections. Each section serves a specific regulatory purpose and must be traceable to the corresponding content in the CER:
| CEP Section | Purpose & Content |
|---|---|
| Scope & Device Description | Define the device(s) covered by the CEP, including model variants, accessories, and intended use configurations. Include technical specifications, materials, design features, and software components relevant to clinical performance. |
| Intended Purpose & Clinical Claims | State the intended purpose exactly as declared in the technical documentation. List all clinical claims (safety, performance, clinical benefit) that the clinical evaluation must substantiate with evidence. |
| Equivalence Strategy | Define whether the evaluation will rely on equivalence to another device. If so, specify the candidate equivalent device and outline the technical, biological, and clinical comparison methodology per MDR Article 61(4)-(5) and MDCG 2020-5. |
| Literature Search Protocol | Predetermine databases (PubMed, Embase, Cochrane, etc.), search strings, Boolean operators, inclusion/exclusion criteria, date ranges, and the appraisal methodology for identified publications. This section must be detailed enough to be reproducible. |
| Clinical Investigation Plan | If clinical investigations are planned or have been conducted, reference the CIP and describe how investigation data will be integrated into the clinical evaluation. For legacy devices, reference any historical study data. |
| Acceptance Criteria | Define quantified, measurable acceptance criteria for each clinical claim. These criteria must be based on the state of the art and must be set before the data analysis begins. not derived retrospectively from results. |
| SOTA Methodology | Describe how the state of the art will be identified and analyzed. Specify the sources (clinical guidelines, systematic reviews, consensus statements, regulatory guidance) and the approach for deriving benchmark values. |
| PMCF Strategy | Outline the post-market clinical follow-up activities that will supplement the pre-market clinical evaluation. Reference the PMCF plan and describe how PMCF data will feed back into CEP and CER updates. |
| Update Schedule & Triggers | Define the update frequency for the CEP and CER (at least annually for Class III/implantables). Specify triggers for unscheduled updates: new safety signals, FSCA, scope changes, new clinical claims, or significant PMCF findings. |
The CEP must be written before the clinical evaluation is conducted. Notified Bodies specifically check whether the CEP was prospectively defined or retrospectively constructed to match existing data. A CEP that reads like a summary of the CER. rather than a protocol that guided the CER. is a red flag during conformity assessment.
Common CEP Deficiencies
Based on Notified Body feedback, MDCG 2020-13 review findings, and recurring observations from conformity assessments, these are the most common deficiencies that undermine Clinical Evaluation Plans:
Vague Acceptance Criteria
Using qualitative statements like “comparable to the state of the art” instead of defining specific, quantified thresholds for safety and performance endpoints. Acceptance criteria must be measurable, predetermined, and traceable to SOTA benchmarks.
Missing SOTA Methodology
Failing to describe how the state of the art will be identified and analyzed. The CEP must specify which clinical guidelines, systematic reviews, and consensus standards will be used. and how benchmark values will be derived from them.
No Equivalence Justification Path
Claiming equivalence without defining, in the CEP, the methodology for demonstrating technical, biological, and clinical similarity. The equivalence strategy must be prospectively planned, not retroactively justified in the CER.
Scope Too Broad or Too Narrow
A CEP that covers too many device variants without differentiating their clinical profiles, or one that is so narrowly scoped that it fails to address all intended use configurations, populations, or clinical claims.
No PMCF Integration
Treating the CEP as a purely pre-market document without defining how PMCF data will feed back into the clinical evaluation cycle. MDR requires a continuous evaluation loop. the CEP must describe this explicitly.
Missing Update Triggers
Defining only a fixed update schedule (e.g, “annually”) without specifying event-based triggers such as new safety signals, field safety corrective actions, scope modifications, or changes to the state of the art that would necessitate an unscheduled CEP revision.
How We Help with Your CEP
Dr. Hatem Rabeh and the Clinical Evaluation Navigator team provide comprehensive CEP support for medical device manufacturers across all device classes and clinical areas:
- ✓ CEP Drafting & Review Complete CEP preparation from scratch or independent review of your existing CEP against Annex XIV Part A requirements and MDCG 2020-13 assessment criteria, ensuring every section meets Notified Body expectations
- ✓ Scope Definition & Device Grouping Defining which device variants, accessories, and configurations can be covered under a single CEP, with clear justification for grouping decisions and identification of variant-specific evaluation requirements
- ✓ Acceptance Criteria Design Developing quantified, SOTA-based acceptance criteria for each clinical claim, including safety endpoints, performance parameters, and clinical benefit thresholds that are defensible during Notified Body review
- ✓ Literature Search Protocol Design Creating reproducible search strategies with predefined databases, search strings, Boolean operators, and inclusion/exclusion criteria that satisfy the systematic review requirements of MDR Annex XIV
- ✓ PMCF Planning & Integration Aligning your PMCF plan with the CEP to ensure a continuous clinical evaluation loop, including defining PMCF objectives that address residual clinical questions identified during the pre-market evaluation
- ✓ Notified Body Response Support Drafting responses to CEP-related deficiency letters, revising the CEP to address specific Notified Body observations, and preparing for conformity assessment reviews
Frequently Asked Questions
What should a CEP contain under MDR?
Under MDR Annex XIV Part A, a CEP must include: the device description and scope, intended purpose and all clinical claims to be substantiated, the equivalence strategy (if applicable), the literature search protocol with predefined databases and search criteria, acceptance criteria for each clinical endpoint, the methodology for identifying the state of the art, the PMCF strategy, and the update schedule with defined triggers. The CEP must be prospectively written. it serves as the protocol that governs the clinical evaluation, not a retrospective summary.
How does the CEP relate to the CER?
The CEP and the Clinical Evaluation Report (CER) are two halves of the same process. The CEP defines the plan: what clinical questions need to be answered, what evidence will be sought, and what criteria will be used to judge that evidence. The CER executes the plan: it presents the clinical data, applies the predefined acceptance criteria, and draws conclusions. Every element of the CER must trace back to the CEP. If a Notified Body finds content in the CER that was not anticipated by the CEP, or acceptance criteria that appear to have been derived after the data was reviewed, this raises serious concerns about the objectivity of the evaluation.
Can one CEP cover multiple device variants?
Yes, a single CEP can cover multiple variants, sizes, or configurations of a device. provided the manufacturer can justify that the variants share the same intended purpose, the same fundamental technology, and the same clinical risk profile. The CEP must explicitly state which variants are covered and, where applicable, identify any variant-specific clinical considerations. For device families with significant differences in materials, intended populations, or clinical applications, separate CEPs or clearly differentiated sections within the CEP may be required. The grouping rationale must be documented and defensible.
How often should the CEP be updated?
MDR requires the clinical evaluation. and by extension the CEP. to be updated on an ongoing basis. For Class III and implantable devices, the update cycle should be at least annual. For Class IIa and IIb devices, the interval should be defined based on risk and may range from one to three years, provided no triggering events occur. Beyond scheduled updates, the CEP must be revised whenever the device scope changes, new clinical claims are added, the state of the art evolves significantly, new safety signals emerge from vigilance or PMCF data, or the equivalence strategy is modified. The update triggers must be predefined in the CEP itself.
What happens if the CEP scope changes during the product lifecycle?
A change in CEP scope. such as adding a new intended population, a new clinical indication, or a significant device modification. triggers a mandatory CEP revision. The revised CEP must reassess the acceptance criteria, evaluate whether the existing clinical evidence remains sufficient, determine if additional literature searches or clinical investigations are needed, and update the PMCF plan accordingly. The corresponding CER must then be updated to reflect the expanded scope. Failing to revise the CEP after a scope change is a common audit finding that can result in suspension of the CE certificate, because the clinical evaluation no longer covers the device as marketed.
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