Mastering the Clinical Evaluation Report (CER)
In our last post, we explored “Common Pitfalls in Clinical Evaluation Reports – Avoid these costly mistakes.”. It’s clear this topic resonates across the medical device community. Building on that, let’s explore what comes next.
Mastering the Clinical Evaluation Report (CER) means more than just meeting regulatory requirements. It’s about creating a clear, credible narrative that demonstrates clinical benefit, minimizes risk, and supports your product’s lifecycle strategy—especially under evolving EU MDR expectations.
In this series, we’ll explore proven methods to strengthen your CER:
- Structuring your clinical evidence
- Bridging data gaps with sound justification
- Aligning with MDCG guidance and Notified Body expectations
Let’s move from identifying common pitfalls to implementing industry best practices.
A Strategic Asset Under EU MDR
In today’s era, Clinical Evaluation Reports (CERs) have emerged as not just compliance requirements—but powerful tools for demonstrating clinical value and ensuring lifecycle safety and performance.
Whether you’re preparing for EU MDR submissions or refining your post-market strategy, your CER needs to reflect more than just baseline expectations. Mastering the art of writing a well-structured CER is critical. It should tell a story of evidence, safety, and clinical impact.
Understanding what a CER is and its regulatory context
Key components and structure
How to conduct a systematic literature review using PICO
Integrating CER with broader regulatory strategy, including Risk Management, PMS, and PMCF
Practical tips and best practices
Clinical Evaluation: A Living Process:
As defined in EU MDR Article 2(44)
Clinical evaluation is “a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer.”
This underscores the fact that your CER must be continuously maintained and updated—not just created for initial CE marking. It’s a lifecycle document, not a one-off submission. They must be continuously updated to reflect:
- New clinical evidence
- Risk-benefit assessments
- Changes to the device or intended use
- Insights from post market surveillance.
A strong Clinical Evaluation Plan (CEP) lays the foundation for managing this continuous process effectively.
Structuring Your CER for Regulatory Success:
Clarity, consistency, and traceability are key to a high- quality CER.
Why it matters
Consistency ensures that your clinical claims are supported by clearly referenced evidence. Traceability allows reviewers to follow your logic and data sources, reducing the risk of non-conformities.
- Use a standardized structure—start with an executive summary, followed by sections such as device description, clinical background, State of the Art, clinical data, and benefit-risk assessment.
- Cross-reference all clinical claims with supporting data from literature, PMCF, or PMS sources.
- Ensure that terms, definitions, and claims are aligned across the CER, Risk Management File, and IFU.
This method builds trust with regulators and internal stakeholders through clear oversight and rigorous scientific methodology.
The Power of a Systematic Literature Review Using Defined PICO:
This method builds trust with regulators and internal stakeholders through clear oversight and rigorous scientific methodology.
Population: Define the target patient group or condition the device is intended for.
Intervention: Clearly state the medical device and its intended clinical use.
Comparator: Identify alternative treatments or devices for comparison, if applicable.
Outcome: Focus on relevant clinical endpoints such as safety, performance, or effectiveness.
When people think of systematic literature reviews, they often imagine complex, high-risk devices. But the truth is, even simple, widely used devices can benefit enormously from a structured, evidence-based review.
Let’s take the peripheral IV cannula – a Class IIa device used daily in nearly every hospital. It seems routine. So why apply a formal literature review using PICO?
Because structured evidence builds scientific credibility, supports regulatory compliance and demonstrates ongoing safety and clinical performance.
Here’s an example using the PICO framework:
Population: Patients requiring peripheral venous access for IV fluids or medication
Intervention: Standard peripheral IV cannula
Comparator: Safety cannulas, Winged needles.
Outcomes: First-attempt success, phlebitis rate, infiltration, local site reactions.
This targeted search led to clinical studies showing
- Comparable success rates between cannula types
- Slightly lower phlebitis and infiltration rates with newer materials.
- No major differences in infection rates with proper aseptic technique
Why use PICO?
- It ensures search strategies are targeted and clinically relevant.
- Enhances transparent and defensible selection of studies.
- Aligns with EU MDR and MEDDEV 2.7/1 Rev. 4 expectations
Tip: Document every step—from inclusion/exclusion criteria to database sources—to ensure traceability and reproducibility.
CERs in Context: Aligning with Risk, PMS & PMCF
A strong CER under EU MDR is more than a stand-alone document—it’s a core element of an interconnected regulatory system.
To meet MDR expectations and build lasting compliance, your CER must be tightly aligned with:
Risk Management (ISO 14971)
The clinical data assessed in the CER should support and validate the device’s risk profile. Conversely, identified risks (e.g., complications, failure modes) must be traced and discussed in the CER—closing the loop between evaluation and risk control.
Post-Market Surveillance (PMS)
PMS feeds the CER with real-world evidence—complaints, vigilance reports, adverse events, and user feedback. These insights are essential to updating the CER regularly and demonstrating the continued safety and performance of the device.
Post-Market Clinical Follow-up (PMCF)
PMCF studies generate ongoing clinical data to address evidence gaps identified in the CER. The outcomes of PMCF activities should be clearly incorporated into CER updates and used to confirm benefit-risk conclusions over time.
TIP: Aligning CERs with Risk Management, PMS, and PMCF not only strengthens clinical validity but also demonstrates control, vigilance, and responsibility—attributes that regulators (and markets) value.
Practical Tips & Best Practices for CERs
A strong CER under EU-MDR is vital for compliance, clinical credibility, and lifecycle safety.
- Start with a Clear CEP: Define objectives, methods, data sources, analyze safety and performance outcomes and align with PMS, PMCF, and Risk Management.
- Use the PICO Framework: Clearly specify Population, Intervention, Comparator, and Outcomes for focused, transparent literature review.
- Follow EU MDR Annex XIV & MEDDEV 2.7/1 Rev. 4: Use these as your structural and methodological guide to avoid gaps.
- Critically Appraise Clinical Data: Assess quality and relevance, justify inclusion/ exclusion with clear criteria and link evidence to safety and performance claims.
- Engage Qualified Clinical Experts: Expert input enhances report depth and credibility of the report.
- Promote Cross-Functional Collaboration: Involve Regulatory, Clinical, Risk, Vigilance, and Quality teams to ensure data consistency.
- Treat CER as a Living Document: Update regularly in sync with PMS and PMCF and incorporate real-world data proactively—not just during renewals
A well-executed CER is more than a regulatory necessity—it’s a strategic asset that reflects clinical excellence, lifecycle control, and market readiness.
