How to Write a Clinical Evaluation Report (CER) for Medical Devices

In the world of medical devices, ensuring safety and effectiveness is not just a regulatory requirement—it’s a responsibility towards patient care. One of the key documents that supports this responsibility is the Clinical Evaluation Report (CER). Whether you’re a manufacturer seeking CE Marking under the EU MDR or aiming for global compliance, writing a clear and thorough CER is essential. In this guide, we’ll walk you step by step through how to write a Clinical Evaluation Report that aligns with regulatory expectations and stands up to scrutiny.

What is a Clinical Evaluation Report (CER)?

A Clinical Evaluation Report is a structured document that demonstrates how clinical data supports the safety and performance of a medical device. It is a regulatory requirement under the EU Medical Device Regulation (MDR 2017/745) and often forms part of the device’s Technical File or Design Dossier.

A CER evaluates:

• Clinical data from existing literature

• Results from clinical investigations

• Post-market surveillance (PMS) and post-market clinical follow-up (PMCF)

• Relevant risk management and biocompatibility testing data

By bringing these elements together, the CER provides regulators and notified bodies with evidence that the device performs as intended.

Why is the Clinical Evaluation Report Important?

Writing a robust Clinical Evaluation Report has several benefits:

• Regulatory Approval: It is mandatory for obtaining Medical Device CE Marking.

• Patient Safety: Demonstrates that the device is safe and effective for its intended use.

• Market Access: Without a CER, a medical device cannot be legally sold in the EU market.

• Continuous Compliance: Regular updates ensure compliance with ongoing post-market surveillance requirements.

Step-by-Step Guide: How to Write a Clinical Evaluation Report

Step 1: Define the Scope of the Evaluation

Start by outlining the medical device’s intended purpose, classification, and risk profile. A clear scope ensures the CER is focused and compliant.

Step 2: Collect Clinical Data

Gather data from multiple sources such as:

• Published scientific literature

• Clinical investigations

• Previous evaluations of equivalent devices

• Real-world evidence from post-market data

  
  

Step 3: Appraise and Analyze the Data

Not all data is of equal quality. Use structured appraisal methods (e.g., GRADE or Jadad scale) to evaluate clinical evidence and determine its relevance, validity, and strength.

Step 4: Demonstrate Clinical Safety and Performance

Analyze how the data supports the device’s safety, effectiveness, and benefit-risk profile. Be specific about clinical endpoints and performance outcomes.

Step 5: Align with Regulatory Requirements

The CER must align with:

• MDR Annex XIV Part A (Clinical Evaluation)

• MEDDEV 2.7/1 Rev. 4 guidelines

• Standards like ISO 14155 for clinical investigations

  
  

Step 6: Structure the Report

A typical Clinical Evaluation Report includes:

1. Executive Summary

2. Device Description and Intended Purpose

3. Clinical Data Collection and Appraisal

4. Data Analysis and Clinical Evidence

5. Risk-Benefit Evaluation

6. Conclusion and Justification for CE Marking

7. References and Appendices

Step 7: Review and Update Regularly

The CER is a living document. Update it based on post-market clinical follow-up (PMCF) and post-market surveillance (PMS) to ensure continuous compliance.

Best Practices for Writing a CER

• Keep the language clear, concise, and evidence-driven.

• Avoid generic statements—always back claims with data.

• Ensure alignment with the device’s risk management file.

• Cross-reference related documentation like the Technical File and QMSR (Quality Management System Regulation) requirements.

• Maintain transparency by acknowledging both strengths and limitations of clinical data.

Conclusion

Writing a Clinical Evaluation Report is a critical step in ensuring medical device compliance, safety, and market access. By following a structured approach—defining the scope, gathering quality clinical data, analyzing results, and aligning with MDR requirements—you can create a CER that not only meets regulatory standards but also builds trust with patients, healthcare providers, and regulators.

If you’re a medical device manufacturer navigating CER preparation, investing in professional support can save time and reduce compliance risks.

FAQs about Clinical Evaluation Reports

Q1. Who is responsible for writing the Clinical Evaluation Report?
Manufacturers are responsible, but they often hire regulatory consultants or clinical experts to prepare the CER in compliance with MDR and MEDDEV 2.7/1 Rev. 4.

Q2. How often should a Clinical Evaluation Report be updated?
CERs should be updated regularly, depending on device risk class: annually for high-risk devices, and every 2–5 years for lower-risk devices, or when significant new data emerges.

Q3. What is the difference between Clinical Evaluation and Clinical Investigation?
Clinical evaluation involves analyzing existing clinical data, while a clinical investigation refers to conducting new clinical trials to collect data on device performance and safety.

Q4. Is a Clinical Evaluation Report required for all medical devices?
Yes, all devices under the EU MDR require a CER, regardless of risk class, though the depth and amount of clinical data required vary.

Q5. Can equivalent devices be used in a CER?
Yes, but strict criteria under MDR apply, and manufacturers must prove scientific and technical equivalence with sufficient evidence.