Clinical Evaluation Plan (CEP) Template – MDR
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
Clinical Evaluation Plan (CEP) Template — EU MDR
What it is: a professionally drafted Word template for the Clinical Evaluation Plan required by Regulation (EU) 2017/745, Article 61 and Annex XIV Part A. The CEP defines the methodology, scope and acceptance criteria for the clinical evaluation of your medical device.
What is included
- PICO research question framework
- State-of-the-art search and selection protocol (data sources, filters, screening, appraisal)
- Equivalence criteria (technical, biological, clinical) per Annex XIV Part A Section 3
- GSPR mapping for clinical evidence requirements
- Document Control section, Authors / Reviewers / Approvers, Related Documents
- References to MDCG 2020-5, 2020-6, 2020-13, 2020-1 (where applicable) and 2024-10 (orphan devices)
Format
1 Microsoft Word .docx file (fully editable) + slim README with usage instructions. Delivered as a small ZIP. Instant download after purchase.
Need the full lifecycle?
This is 1 of 8 templates in the EU MDR Clinical Documentation Kit. Save 28% with the bundle: EUR 399 vs EUR 552 buying individually.
€69.00
Alessandro Stella
Alessandro Stella is a freelance Medical Device Regulatory Consultant and ISO 13485 / ISO 9001 Lead Auditor based in Italy. With over 13 years of experience spanning R&D, Quality, and Regulatory Affairs, he has supported companies across Europe and beyond in EU MDR technical documentation, QMS implementation, ISO 13485 compliance, and FDA submissions. His device expertise covers cardiovascular devices, AI-based standalone software, robotic surgery systems, active wearables, and more. Alessandro is the founder of MD Regulatory.