Clinical Evaluation Plan (CEP) is the pre-specified document that defines how a medical device manufacturer will generate, collect, and appraise clinical data to demonstrate a device’s safety and performance. Required under EU MDR 2017/745 Annex XIV Part A, it sets the scope, methods, and acceptance criteria before any clinical evaluation begins.
What is a Clinical Evaluation Plan (CEP)?
A Clinical Evaluation Plan (CEP) is the strategy document that governs clinical evaluation for a medical device under the EU Medical Device Regulation. Clinical evaluation itself is defined in Article 2(44) of EU MDR 2017/745 as the systematic and planned process to generate, collect, analyze, and assess clinical data relating to a device. The CEP is where that process is planned.
It sits early in the device lifecycle, ideally during design and development, and feeds directly into the Clinical Evaluation Report (CER). The CEP states what you intend to prove; the CER records what the data actually showed. The plan is the methodological contract a Notified Body reads first in your technical documentation.
Why the Clinical Evaluation Plan (CEP) matters in medical device development
Regulators treat the CEP as evidence of a defined, methodologically sound procedure. Article 61 of EU MDR 2017/745 requires every device, including Class I self-certifying products, to plan its clinical evaluation through a CEP. Skip it, write it thinly, or write it after the fact, and you expose the whole submission.
The stakes are concrete. A Notified Body that cannot trace your acceptance criteria back to a pre-specified plan may raise nonconformities that delay CE marking by months. Retrospective plans are a classic finding: if the CEP looks reverse-engineered to fit data you already had, reviewers discount the conclusions. Because the CEP also links to the risk management file and the post-market surveillance plan, an incoherent plan cascades into other parts of the technical file. Time-to-market, audit exposure, and patient safety all ride on it.
Key components of a Clinical Evaluation Plan (CEP)
Annex XIV Part A sets the minimum content. A compliant CEP should include at least the following:
- The General Safety and Performance Requirements (GSPRs). Identify the Annex I requirements that need support from clinical data, plus a justification for any deemed not relevant.
- The intended purpose of the device. State it precisely.
- Target groups. Define the intended target groups, with clear indications and contraindications.
- Intended clinical benefits. Express these as specific and measurable clinical outcome parameters.
- Clinical safety evaluation methods. Define methods to examine qualitative and quantitative aspects of clinical safety, with clear reference to the benefit-risk determination.
- Benefit-risk parameters. Establish parameters for the benefit-risk ratio for each intended purpose, based on the current state of the art in the relevant medical field.
- Equivalence strategy. Describe how equivalence to another device will be demonstrated, if claimed.
- Literature search protocol. Specify databases, search strings, and inclusion/exclusion criteria so the literature search is reproducible.
Where a clinical investigation is planned to close a data gap, that study should follow ISO 14155, the good clinical practice standard for medical device investigations. The fourth edition, ISO 14155:2026, was published in March 2026 and replaced the 2020 edition with no transition period, so plans should reference the current version. Note a live harmonization gap: EN ISO 14155:2020/A11:2024 remains the MDR-harmonized text for now, while the 2026 edition represents the current state of the art. The CEP should also cross-reference your quality management system procedures under ISO 13485 and the risk management file under ISO 14971.
Common challenges and best practices
The most frequent mistake is writing the CEP as a retrospective narrative rather than a forward-looking plan. Draft it before you collect or appraise data, and date it accordingly.
A second common gap is vague acceptance criteria. “The device is safe and effective” is not a benchmark. Define measurable parameters, such as a diagnostic accuracy threshold or a complication rate, and extract benchmark values from a state-of-the-art analysis so the later CER can compare device data against them.
Equivalence is a third pitfall. Claims of clinical, technical, and biological equivalence are scrutinized heavily, so plan the justification and data access up front rather than asserting it later.
Good practice is to treat the CEP, CER, risk file, and post-market clinical follow-up plan as one connected system. When MDCG 2020-13 assessment expectations, the risk report, and the clinical claims point to the same benefit parameters, reviewers move faster, and findings drop.
How SJML helps with Clinical Evaluation Plan (CEP)
Syrma Johari MedTech (SJML) supports clinical evaluation as part of its Compliance-as-a-Service offering for medical device manufacturers. The QARA team helps prepare Clinical Evaluation Plans, conduct systematic literature reviews, structure equivalence arguments, and carry the work through to the Clinical Evaluation Report and, where relevant, the Summary of Safety and Clinical Performance. This connects to broader regulatory support across EU MDR and IVDR technical documentation, risk management files under ISO 14971, and post-market surveillance planning, so the CEP is built to sit consistently within the wider technical file rather than in isolation.
Frequently asked questions
Yes. Article 61 and Annex XIV Part A of EU MDR 2017/745 require every medical device, including Class I self-certifying devices, to plan its clinical evaluation through a CEP. The plan is part of the technical documentation a Notified Body assesses, and its absence or a retrospective version is itself an audit finding.
The Clinical Evaluation Plan (CEP) is the strategy: it defines scope, methods, data sources, and acceptance criteria before evaluation begins. The Clinical Evaluation Report (CER) is the outcome: it documents the clinical data collected, the analysis performed, and the conclusions drawn. You write the CEP first, then execute it and record results in the CER.
Write the CEP early, during the design and development phase, before any clinical data is collected or appraised. Drafting it up front ensures data requirements are integrated from the start and aligned with the intended purpose. A plan written retrospectively to fit existing data undermines the credibility of the evaluation and is a common Notified Body finding.
The CEP is governed by EU MDR 2017/745, Article 61, and Annex XIV Part A. Where a clinical investigation is needed, it follows ISO 14155, currently the 2026 fourth edition. The plan also connects to ISO 14971 for risk management and ISO 13485 for quality management, and MDCG 2020-13 informs the structure of the resulting CER.
Related terms
- Clinical Evaluation Report (CER)
- Post-Market Clinical Follow-up (PMCF)
- General Safety and Performance Requirements (GSPR)
- EU MDR 2017/745
- ISO 14155
