Clinical Evaluation Report (CER) Template – MDR
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
Clinical Evaluation Report (CER) Template — EU MDR
What it is: a professionally drafted Word template for the Clinical Evaluation Report required by Regulation (EU) 2017/745, Article 61 and Annex XIV Part A. The CER documents the results of the clinical evaluation, structured for Notified Body review.
What is included
- Executive Summary (stand-alone synthesis for NB reviewer)
- Preclinical evidence section (bench testing, biocompatibility, sterilisation, design validation)
- State-of-the-art analysis
- GSPR conformity assessment with clinical evidence
- Benefit-risk analysis aligned with the Risk Management File
- Equivalence demonstration framework (Class III contractual data access included)
- References to MDCG 2020-13, 2020-1 (software) 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
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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.