Clinical Evaluation Plan (CEP) Template – MDR

The Clinical Evaluation Plan (CEP) is a mandatory document under Regulation (EU) 2017/745, Article 61 and Annex XIV Part A. This CEP template gives RA/QA professionals a professionally drafted Word structure covering methodology, scope and acceptance criteria for the clinical evaluation of any medical device class — Class I through Class III.

Use this CEP template to define your evaluation strategy before writing a single line of clinical evidence. A well-structured CEP is the first document a Notified Body auditor will request during technical file review.

What this CEP template includes

• PICO research question framework
• State-of-the-art search and selection protocol (data sources, filters, screening criteria, appraisal methodology)
• Equivalence criteria assessment (technical, biological, clinical) per Annex XIV Part A Section 3 and MDCG 2020-5
• GSPR mapping table for clinical evidence requirements
• Benefit-risk framework linkage (MDR Annex I §1)
• Document Control section with Authors / Reviewers / Approvers table
• Related Documents register
• References to MDCG 2020-5, 2020-6, 2020-13, 2020-1 and 2024-10 (orphan devices)

Format

1 Microsoft Word (.docx) file, fully editable + slim README with usage instructions. Delivered as a ZIP file. Instant download after purchase.

Compatible with all device classes. Works for Class I, IIa, IIb and Class III medical devices under EU MDR 2017/745.

Need the full clinical lifecycle?

This CEP template is 1 of 8 templates in the EU MDR Clinical Documentation Kit. Save 28% with the bundle: €399 vs €552 buying individually.