What Is a Clinical Evaluation Report (CER)? A Beginner’s Guide for EU MDR Compliance

‍Why Your Device Needs a CER

Regulatory gatekeeper

A CER proves your device meets the MDR’s General Safety and Performance Requirements (GSPRs) that are appropriate for your device.

Market-access trigger

Notified Bodies won’t schedule a conformity-assessment audit without a complete, up-to-date CER.

Risk-management linchpin

Post-Market Clinical Follow-Up (PMCF) plans—and your Periodic Safety Update Report (PSUR)—must reference CER conclusions and are necessary for conformity to the risk management process.

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Key Components of a Clinical Evaluation Report

A well-written CER follows the structure outlined in MEDDEV 2.7/1 Rev. 4 and aligns with MDR Annex XIV Part A. The CER may also reference MDCG guidance documents: 2020-5 (Guidance on equivalence); 2020-6 (Sufficient clinical evidence for legacy devices); and 2020-13 (MDCG CER Template) or other MDCG documents. While every device is different, most CERs include the following sections:

Device Description & Intended Use

Details the device, its classification, and its medical purpose. This section also includes indications, contraindications, and target populations.

State of the Art

Describes current medical practice and establishes the baseline for comparing the safety and performance of your device to other available therapies and/or devices.

• Clinical Background - Outlines the disease or condition the device is intended to address, alternative treatment options, and any relevant standard of care.
• Benchmark/Similar devices - Identifies comparable devices to the subject device and establishes the safety and performance profile of the intended therapy based on specifications and published literature.

Clinical Data

Includes all available data related to the subject device. Types of clinical data can include:

• Clinical investigations conducted by the manufacturer
• Literature data for the subject device and/or equivalent devices.
• Post-market data from vigilance systems and user feedback
• Registry data and real-world evidence

Appraisal and Analysis

A systematic review of the quality, relevance, and validity of the data. The writer must determine if there is sufficient evidence to support the device’s safety and performance under the MDR.

Conclusion: Benefit-Risk Analysis

Summarizes whether the device meets the appropriate General Safety and Performance Requirements (GSPRs), and if the benefits of the device outweigh the risks for the intended patient population. The benefit-risk analysis must take into account device safety, performance, and known side effects.

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Continuous CER Updates as Required by EU MDR

Under EU MDR, Clinical Evaluation Reports are not static documents. The frequency of updates depends primarily on the risk class of the device.  

Device Classification and CER Maintenance

The EU MDR classifies devices into four risk-based categories. Each class has different expectations for how frequently the CER must be reviewed and updated:

Class III & Implantable Devices (Highest risk)
➤ CER must be updated at least annually.
These devices require the most scrutiny. Frequent updates are essential to incorporate new clinical data, especially post-market clinical follow-up (PMCF) results.

Class IIb Devices (Higher risk)
➤ Update required at least every two years, or sooner if new data emerges that could affect the benefit–risk determination.

Class IIa Devices (Medium risk)
➤ Update required at least every three years, depending on post-market findings, product changes, or regulatory expectations.

Class I Devices (Low risk)
➤ May require periodic updates based on post-market surveillance, although the formal CER update cycle is less prescriptive.

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What are other triggers to a CER update?

In addition to the regulatory minimums, a CER should be updated when:

• Significant new clinical data becomes available
• The device is modified in design or intended use
• Post-market surveillance identifies safety concerns
• New guidance from authorities (e.g., MDCG) changes expectations

Proactive CER maintenance is critical: waiting for a Notified Body to flag deficiencies can lead to delays, increased scrutiny, or certification risk.

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Next Steps for Newcomers to CER Authoring

1. Kick-off with a Gap Assessment – Compare existing data to MDR Annex I & XIV requirements.
2. Draft a Robust Clinical Evaluation Plan (CEP) Early – Best practices dictate that a Clinical Evaluation Plan, the plan that will guide the execution of the CER, should be written and approved before the CER.
3. Build a Multi-Disciplinary Team – Include clinical, regulatory, R&D, design engineering, quality, and medical writing expertise.
4. Plan for Post-Market Clinical Follow-up (PMCF) – Data collection is an ongoing process under MDR and manufacturers must plan for robust post-market clinical follow-up. Budget and timeline can eclipse the initial CER if left as an afterthought.

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Additional Documents Required under EU MDR

Clinical Evaluation Plan (CEP)
Defines objectives, scope, endpoints, approach to clinical data, and literature-search strategy before data collection starts. Annex XIV Part A of the MDR calls it mandator Clinical Evaluation Plan (CEP)

Post-Market Clinical Follow-Up (PMCF) Plan
Defines the objectives, methodology, and timelines for collecting post-market clinical data. It outlines how the manufacturer will proactively gather evidence to address clinical uncertainties and confirm the ongoing safety and performance of the device. This plan is a critical part of the Clinical Evaluation process and must be aligned with the overall Post-Market Surveillance (PMS) system.

Post-Market Clinical Follow-Up (PMCF) Report
Summarizes the data collected through PMCF activities, such as surveys, observational studies, or registry data, and evaluates how this information impacts the benefit–risk profile of the device. It demonstrates whether clinical evidence gaps have been addressed and supports the continuous validation of device performance and safety throughout its lifecycle.

Post-Market Surveillance (PMS) Plan
Describes systematic procedures for collecting, analyzing, and responding to post-market data. Forms the foundation for continuous safety and performance monitoring under Article 84.

Periodic Safety Update Report (PSUR)
Aggregates and evaluates post-market data over a defined period. Required for Class IIa, IIb, and III devices. Must include conclusions on benefit–risk and actions taken.

PMS Reports for Class I devices
Establishes a systematic approach for monitoring the performance and safety of a medical device once it is on the market. While Class I devices typically present lower risk, manufacturers are still required under EU MDR to proactively gather, assess, and analyze post-market data to ensure continued compliance and patient safety.

Summary of Safety and Clinical Performance (SSCP)
Delivers a public-facing summary of the device’s clinical evidence, safety profile, and performance. Required for Class III and implantable devices under Article 32.

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Need Expert Help with Your CER?

Global Regulatory Writing & Consulting has authored and audited hundreds of MDR-ready CERs across all device classes with zero major nonconformities to date. Our seasoned writers and consultants can provide any number of the following services. We are eager to work with you and your team to find what suite of services may be best for you.  

• Conduct a comprehensive gap analysis to assess your current documentation against EU MDR clinical evaluation requirements
• Author or critically review your Clinical Evaluation Plan (CEP) and data sources to ensure adequate and comprehensive safety and performance data
• Advise on appropriate clinical evaluation strategy to make sure your device is meeting MDR requirements
• Write a complete CER, including designing and executing systematic literature reviews that meet MDR expectations for transparency, reproducibility, and relevance
• Ensure alignment between CER conclusions and related documentation, including PMS Plans, PMCF Plans, and PSURs. Our team can author these documents as part of a fully integrated deliverables package 
• Provide end-to-end project management across your clinical evaluation workflow, from initial planning and data collection through writing, quality review, and submission support

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Are you ready to streamline your clinical evaluation process?
Let us help you assess your full device portfolio and map out a strategic, efficient path to compliance. From tailored clinical evaluation processes to full documentation support, our experts are equipped to guide you every step of the way.

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Reach out today to accelerate your journey to MDR readiness.