Clinical Evaluation Report

Ensure your medical device complies with the European Union Medical Device Regulation (EU MDR) 2017/745 with our Clinical Evaluation Report (CER) Template. Designed for medical device manufacturers and regulatory teams, this template provides a structured and detailed format to demonstrate the safety and clinical performance of your medical device.

Key Features:

• EU MDR 2017/745 Compliant: Fully aligned with the stringent requirements of EU MDR 2017/745, ensuring your clinical evaluation report meets European regulatory standards.
• Detailed & Structured Layout: The template includes all the mandatory sections required for a compliant CER, including clinical data analysis, demonstration of equivalency (if applicable), SOTA, required clinical data, risk-benefit assessment, post-market surveillance data, and clinical conclusions.
• Comprehensive Instructions: Each section comes with detailed guidance, explaining what information to include, making it suitable for users at any experience level in clinical evaluations.
• Pre- and Post-Market Data Integration: Designed to accommodate both pre-market clinical data and post-market surveillance (PMS) information, making it suitable for initial product launch as well as ongoing compliance needs.
• Risk-Benefit Analysis: Provides clear sections for assessing the risks versus benefits of your medical device, following the guidelines for clinical risk management under EU MDR.
• Literature Review Integration: Includes structured space to document relevant clinical studies, peer-reviewed articles, and medical literature to support the safety and performance of your device.
• Customizable: Easily adaptable to various types of medical devices, whether Class IIa, IIb, or III, ensuring the template can cater to the complexity of different products.
• User-Friendly: Organized in a clear and logical format, ensuring that all required elements of the clinical evaluation process are easily followed and documented.

Why Choose This Template?

• Save Time and Effort: Avoid the challenge of creating a CER from scratch. This template accelerates the documentation process, providing an organized and ready-made solution.
• Regulatory Assurance: The template’s structure and content are aligned with the most recent EU MDR 2017/745 guidelines, increasing the likelihood of a successful regulatory submission.
• Flexible for Various Devices: Whether your product is a low-risk device or a high-risk implant, active or non-active, invasive or non-invasive, this template is versatile and suitable for a wide range of medical devices.

What’s Included?

• Fully editable template in Word format
• Clear instructions for completing each section
• Example for how to complete the template
• Section placeholders for relevant data (clinical studies, risk assessment, PMS)
• Checklist of EU MDR 2017/745 clinical evaluation requirements

Compliance Made Simple

This template is designed to help you achieve a well-structured, robust clinical evaluation report that meets the expectations of EU regulatory authorities.