Why Clinical Evaluation Reports Matter
The CER is the cornerstone of regulatory compliance for medical devices in Europe. Here's why it's critical to your success.
Regulatory Requirement
The EU MDR 2017/745 mandates a comprehensive CER for all medical devices. It's not optional—it's the foundation of your regulatory submission.
Safety & Performance Evidence
The CER demonstrates that your device meets General Safety and Performance Requirements (GSPR) and provides clinical evidence of efficacy and safety.
Notified Body Approval
Notified bodies scrutinize CERs carefully. A well-structured, evidence-based report accelerates approval and reduces rejection risk.
Post-Market Surveillance
The CER must be updated throughout the device's lifecycle. Continuous data collection and analysis ensure ongoing compliance and market presence.
Competitive Advantage
A robust CER demonstrates clinical rigor and quality, building trust with healthcare providers, regulators, and end-users.
Risk Mitigation
A comprehensive CER identifies potential risks early, allowing you to implement mitigation strategies and avoid costly recalls or regulatory actions.
The 5 Essential Components of a Clinical Evaluation Report
A compliant CER follows a standardized structure defined by Annex XIV of the EU MDR. The depth and detail of each section depend on the device's risk classification, but the framework remains consistent. Below are the five core components every CER must include.
Summary
A comprehensive overview of the entire report, including:
- Intended use and target population
- Medical indications and contraindications
- Benefits and risks summary
- Overall clinical evidence conclusion
Scope
Detailed technical and clinical specifications:
- Device description and technology
- Model, size, software version
- Available accessories and variants
- Intended use and patient population
Clinical Background
Contextual research and regulatory landscape:
- Medical condition epidemiology
- Current treatment standards
- Applicable guidelines and standards
- Literature search methodology
Clinical Data Analysis
Evidence evaluation and interpretation:
- Pre-market clinical trial data
- Post-market surveillance data
- Literature review findings
- Safety and performance assessment
Conclusion & References
Final assessment and supporting documentation:
- Safety and performance conclusion
- Risk-benefit analysis
- Further research recommendations
- Complete reference list
The Clinical Evaluation Process: Step by Step
Annex XIV of the EU MDR defines a structured process for clinical evaluation. While represented as sequential steps, real-world evaluation often involves feedback loops and iterative refinement.
1. Planning & Strategy
Define the clinical evaluation plan, identify relevant outcome parameters, establish benchmarks based on state-of-the-art (SOTA), and determine data requirements.
2. Data Collection
Gather pre-market clinical trial data, post-market surveillance data, literature reviews, and real-world evidence relevant to your device's safety and performance.
3. Data Appraisal
Critically evaluate the quality, relevance, and validity of collected data using systematic review methodology and predefined criteria.
4. Data Generation (if needed)
Conduct additional clinical studies or trials if existing data is insufficient to support safety and performance claims.
5. Data Analysis & Conclusions
Synthesize findings, assess safety and performance, identify risks, and draw evidence-based conclusions about device compliance with GSPR.
6. Post-Market Surveillance
Establish ongoing data collection mechanisms, periodic updates, and continuous monitoring to maintain CER validity throughout device lifecycle.
Key MDCG Guidelines for Clinical Evaluation
The Medical Device Coordination Group (MDCG) has published several guidance documents that clarify clinical evaluation requirements under the EU MDR. These guidelines are essential references for structuring your CER and ensuring compliance with regulatory expectations.
| Guideline | Focus Area | Key Relevance to CER |
|---|---|---|
| MDCG 2020-5 | Clinical Evaluation | Core guidance on clinical evaluation planning, data collection, and appraisal methodologies for CER development. |
| MDCG 2020-6 | Equivalence | Defines requirements for demonstrating device equivalence to predicate devices in your CER. |
| MDCG 2021-6 | Performance Evaluation | Specifies performance evaluation requirements and how to present performance data in the CER. |
| MDCG 2019-9 (Rev. 1) | SSCP & Clinical Data | Guidance on Summary of Safety and Clinical Performance (SSCP) and integration of clinical data into regulatory submissions. |
| MDCG 2022-21 | PMCF & Post-Market | Requirements for post-market clinical follow-up (PMCF) and how to update the CER with post-market data. |
| MDCG 2023-3 | Clinical Evaluation Updates | Latest guidance on periodic CER updates and continuous clinical evaluation throughout device lifecycle. |
| MDCG 2020-13 | Literature Review | Systematic review methodology and literature search best practices for CER development. |
Key Takeaways: CER Success Factors
Master these critical elements to ensure your CER meets notified body expectations and accelerates regulatory approval.
Robust Planning
A well-defined clinical evaluation plan is the foundation. Clearly specify outcome parameters, benchmarks, and data requirements upfront.
Systematic Review
Use rigorous, transparent methodology for literature searches and data appraisal. Document all search strategies and selection criteria.
Risk-Benefit Analysis
Clearly articulate the risk-benefit profile. Address potential risks honestly and explain mitigation strategies.
Evidence Quality
Prioritize high-quality clinical evidence. Pre-market trials are stronger than post-market data, but both are valuable.
GSPR Compliance
Explicitly demonstrate how your device meets all General Safety and Performance Requirements. Map evidence to each GSPR element.
Continuous Updates
Plan for post-market surveillance and periodic CER updates. The CER is a living document, not a one-time submission.
How Eclevar Helps You Master Clinical Evaluation Reports
Our team of regulatory experts and former notified body leaders brings decades of experience to CER development. We ensure your report meets the highest standards and accelerates notified body approval.
Our CER Expertise
At Eclevar, we understand what notified bodies expect because we've worked alongside them. Our team includes former notified body leadership who have contributed to MDCG guidance documents on clinical evaluation. We know the regulatory landscape, the common pitfalls, and the best practices that lead to approval.
Whether you're developing your first CER or updating an existing one, we provide end-to-end support to ensure compliance, quality, and efficiency.
Clinical Evaluation Planning
We develop robust clinical evaluation plans that define outcome parameters, establish state-of-the-art benchmarks, and identify all necessary data sources.
- Comprehensive evaluation strategy
- GSPR mapping and alignment
- Data requirements analysis
- Timeline and resource planning
Systematic Literature Review
Our medical writing experts conduct rigorous, transparent literature searches and data appraisal using established systematic review methodology.
- Comprehensive literature searches
- Quality assessment of evidence
- Data extraction and synthesis
- PRISMA-compliant documentation
CER Writing & Compilation
We write and compile comprehensive, notified body-ready CERs that clearly articulate safety, performance, and regulatory compliance.
- Full CER document development
- Executive summary and scope
- Clinical background and analysis
- Risk-benefit assessment
Regulatory Compliance Review
We review your CER against MDCG guidelines and EU MDR requirements to identify gaps, inconsistencies, and areas for improvement before submission.
- MDCG guideline alignment
- MDR compliance verification
- Notified body readiness assessment
- Gap analysis and recommendations
Post-Market Surveillance & Updates
We establish post-market surveillance frameworks and manage periodic CER updates to maintain compliance throughout your device's lifecycle.
- PMCF study design and execution
- Post-market data integration
- Periodic CER updates
- Continuous compliance monitoring
Expert Guidance & Training
Our regulatory experts provide guidance, training, and consultation to help your internal team understand CER requirements and best practices.
- Regulatory training workshops
- One-on-one expert consultation
- Best practices guidance
- Notified body interaction support
Why Manufacturers Trust Eclevar for CER Development
Our team brings unparalleled expertise in clinical evaluation under the EU MDR. We've worked on hundreds of clinical evaluations across all therapeutic areas and device types—from Class I to Class III devices.
Our leadership includes former notified body executives who have reviewed CERs from the regulatory perspective. This unique vantage point allows us to anticipate notified body concerns and address them proactively in your CER.
Ready to Master Your Clinical Evaluation Report?
Let Eclevar's regulatory experts guide you through the CER process. From planning to post-market surveillance, we ensure your device gains approval and maintains compliance.