If you work with medical devices, the Clinical Evaluation Report (CER) is one of those documents that can’t be ignored. It’s a key piece of the Medical Writing puzzle for staying compliant with the EU MDR. The CER summarizes the clinical data available and presents the clinical evidence that supports the performance and safety of the medical device.
The tricky part? The MDR tells you that you need a CER, but it doesn’t spell out exactly how it should look or what sections to include. That’s where guidance documents come into play. They fill in the gaps and give manufacturers a clearer idea of what Notified Bodies expect to see. Two in particular are indispensable:
- MEDDEV 2.7/1 Rev. 4 (2016) – Clinical Evaluation: A Guide for Manufacturers and Notified Bodies
- MDCG 2020-13 – Clinical Evaluation Assessment Report (CEAR)
Together, they lay out the framework for what a strong CER should look like. Let’s walk through the essential elements step by step.
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1. Introduction: Setting the Scene
- Start by laying out the purpose and scope of the CER.
- Reference the Clinical Evaluation Plan (CEP), this is the roadmap that guides the entire report.
- Outline the strategy: what types of data you’ll present, how they demonstrate compliance with the General Safety and Performance Requirements (GSPRs), and how these are sufficient for the type of devices under evaluation.
- List the documentation that feeds into the evaluation, so the reviewer knows the foundation you’re working from.
2. Present the Device Under Evaluation
- Give a clear device overview: intended purpose, indications, and target population.
- State the MDR classification and justify the risk class.
- Add context by describing the device’s development history and regulatory approval journey, this helps position the device within its broader lifecycle.
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3. Present the Claims
- This is where you set out what the device promises to deliver. Clearly state device claims (clinical benefits, clinical and/or technical claims).
- Clearly state whether each claim ties to safety or performance, since regulators will look for that distinction.
- To make these claims meaningful, define measurable endpoints (parameters) and establish acceptance criteria. These criteria should be grounded in a state‑of‑the‑art analysis, drawing on benchmark data from comparable devices. By doing so, you create a clear reference point: how does your device measure up against what’s already available?
- With endpoints and benchmarks in place, you can then quantitatively assess whether the claims are supported by the clinical evidence. This structured approach ensures that your CER doesn’t just describe the device’s benefits, it demonstrates them with data.
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4. Similar or Equivalent Devices
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List any devices you consider similar or equivalent.
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If claiming equivalence to another device, provide justification in line with MDCG 2020-5.
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This section is critical if you’re relying on external data to support your evaluation.
5. Data Generated by the Manufacturer
Summarize the evidence you already have in‑house:
- Risk Management: analysis, mitigation, and residual risks.
- Pre‑clinical data: verification, validation, biocompatibility, usability.
- Pre‑market clinical data: studies performed on the device.
- Post‑market data: PMS activities, complaints, CAPAs, recalls, PMCF, vigilance.
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6. Clinical Background & State of the Art (SOTA)
- Set the context of the evaluation with a state‑of‑the‑art review.
- Use the publications from the literature search to describe the current clinical landscape, including data on similar devices and alternative treatments, which are in turn used to define the acceptance criteria for endpoints (see point 3).
- This context helps to show how your device fits into the bigger picture.
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7. Literature Data
- Present the publications included from your literature search.
- Separate those that provide data on your device from those that inform on similar devices.
- Transparency here strengthens the credibility of your CER.
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8. Adverse Events (AE) Databases
- Summarize findings from relevant AE databases.
- Include data for your device and comparable devices to build a comprehensive risk profile.
- This demonstrates that you’ve considered both known and potential risks.
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9. Analysis of Clinical Data
- Bring everything together. Show how the data presented throughout the CER supports the device’s claims and compliance with GSPRs.
- Be balanced: include both favorable and unfavorable findings. A strong CER doesn’t shy away from limitations; it explains how they’ll be addressed.
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10. Conclusion
- Wrap up with clear statements on whether the GSPRs are met.
- If gaps remain, explain how they’ll be addressed, for example, conducting a PMCF study or updating risk management activities.
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11. Changes Since the Last Evaluation
- Document any updates or modifications since the previous CER. This shows continuity and responsiveness to new information.
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12. Next Evaluation Date
- Specify when the next CER will be performed, based on the device’s risk profile. This demonstrates proactive planning and compliance with MDR expectations.
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13. References
- List all references used throughout the CER. A well‑curated reference section reinforces transparency and traceability.
Bonus Tips for a Strong CER:
- Use a clear structure with sections, subsections, tables, and figures.
- Cross‑reference tables, figures, and sections for easy navigation.
- Include a list of abbreviations and use them consistently.
- Document the qualifications of evaluators: Notified Bodies expect to see relevant expertise.
Takeaway
A CER isn’t just a box to tick for EU MDR compliance, it’s your chance to show, in a structured and transparent way, that your device truly delivers on safety and performance. The strongest CERs are built on MDR Annex XIV, Part A, shaped by the practical guidance in MEDDEV 2.7/1 Rev. 4 and the MDCG documents, and include clear claims with measurable endpoints. They balance positive and negative findings, and explain how any gaps will be addressed. Done well, a CER not only satisfies regulators but also builds confidence with all stakeholders involved, reinforcing the credibility of your device in the market.
At Qserve, we bring extensive experience in drafting and refining Clinical Evaluation Reports to meet EU MDR compliance requirements. Whether you need support at the planning stage, during writing, or in final review to determine the gaps, our team is ready to help ensure your CER is clear, compliant, and aligned with Notified Body expectations.