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The Clinical Evaluation Plan (CEP) is established and updated in support of a clinical evaluation of a medical device, which is a systematic and planned process to continuously generate, collect, analyze and assess the clinical data pertaining to the device. The CEP should identify the general safety and performance requirements that require support from relevant clinical data and should include a clinical development plan as well as a post-market clinical follow-up with an indication of milestones and a description of potential acceptance criteria. Requirements for the CEP are detailed in Annex XIV (Part A, Section 1) of the Medical Devices Regulation (2017/745).
Emtex Life Science medical writers can manage and coordinate the document development process (eg, compile contributions, circulate for review, implement comments) and can help to generate a clear, well structured, and coherent document.
FAQ: Clinical Evaluation Plan (CEP)
What is a Clinical Evaluation Plan (CEP) and what is its purpose?
A CEP is a document established and updated to support the clinical evaluation of a medical device. It defines the systematic and planned process used to generate, collect, analyze, and assess clinical data related to the device.
What information must be included in a CEP?
A CEP must identify the general safety and performance requirements that require support from clinical data. It should include a clinical development plan, a post‑market clinical follow‑up plan, relevant milestones, and a description of potential acceptance criteria.
When is a CEP needed?
A CEP is needed throughout the clinical evaluation of a medical device. It must be established early and updated continuously as new clinical data become available, ensuring that the evaluation follows a structured and compliant process.
How can Emtex Life Science support the preparation of a CEP?
Emtex Life Science can support the CEP process by coordinating input from the required functions, managing review cycles, implementing comments, and ensuring that the CEP is clearly structured and aligned with regulatory expectations. Emtex can also help maintain the CEP as updates are needed during the evaluation.
Why is professional medical writing support valuable for a CEP?
Professional medical writing support is valuable because a CEP must be coherent, well-structured, and fully aligned with the clinical evaluation process and regulatory requirements. A medical writer helps ensure clarity, consistency, and logical flow, which supports the quality and reliability of the clinical evaluation.