CER Authoring Best Practices: Getting It Right the First Time

A well-structured Clinical Evaluation Report (CER) is a central element of an EU MDR technical file submission. The clinical evidence presented in a CER demonstrates that the device in question meets applicable safety and performance requirements, and thus, can support an efficient conformity assessment.

The objective, therefore, should not be just to prepare a document, but to develop a device-focused, evidence-driven clinical evaluation that can withstand regulatory scrutiny from the outset.

Start With the Device

One of the most common but largely avoidable gaps in CERs is the lack of information in the devices being evaluated. A strong clinical evaluation strategy and smoother clinical review process stems from the clear presentation of the device(s) in question. Notified Bodies have repeatedly highlighted receiving CERs for review with no clarity of the device variants, components, accessories, compatible devices or systems, mode of action, and specifications that determine their safety and performance characteristics. A simple pictorial or diagrammatic representation of the device components can help in a more precise understanding of the device but is often missing from these documents.

The clinical evaluation strategy and evidence is dependent on its clinical characteristics, such as the intended purpose, indications, target patient population, user group, and claims made by the manufacturer that are clinical in nature. These elements must be clearly determined and stated, and must remain consistent across the CER, risk management file, labeling, and broader technical documentation.

Build a Defensible Clinical Evidence Strategy

A credible CER should demonstrate more than the existence of published literature. It should establish what data sources were considered, the quality and suitability of evidence and why it is relevant to the device, and whether it adequately supports safety, clinical performance, and clinical benefit in comparison to the state of the art.

Your clinical reviewer will expect the following with particular interest:

• List of internal and external data sources and determination of level of evidence.
• A clearly defined and traceable systematic literature search strategy, including databases, search terms, inclusion/exclusion criteria, and rationale.
• Critical appraisal of the quality, relevance, and methodological limitations of individual sources.
• A transparent assessment of whether clinical data genuinely supports the device’s intended purpose and claims and strong, evidence-based justification where clinical data is not utilized for demonstrating conformity to GSPRs.
• A scientific and regulatory justification for equivalence where equivalence is claimed.
• Clear acceptance criteria for parameters used to evaluate device safety and performance, with rationale.
• Appropriate treatment of gaps, uncertainties, contradictory findings, and limitations.
• A clear conclusion and subsequent actions to be taken as the manufacturer to address gaps, uncertainties, contradictory findings and limitations.
• Traceability with PMS, PMCF, and risk management.

Ensure Clinical Evaluation and Risk Management Tell the Same Story

A CER should never be developed in isolation.

The clinical evaluation must address the clinical questions on safety, performance, and benefit-risk arising from the specific device and its intended purpose. Under the EUMDR framework, clinical evaluation is interconnected with risk management and post-market surveillance (PMS), and it is supposed to be set up in an iterative and feedback loop, so that there is proactive rather than reactive data gathering and evaluation.

This makes cross-consistency and traceability essential, and the technical file is expected to present a coherent device story.

A practical question for a clinical evaluator is: If a Notified Body reviewer compares these documents side by side, will the same conclusions emerge?

If not, the documentation must be reconciled before submission.

Notified Body Expectations

Notified body clinical review should never be treated as a formality, or an isolated activity limited only to the CER. The clinical evaluation is assessed in the context of the broader technical documentation, including clinical evidence, equivalence, benefit-risk determination, risk management, labeling, and PMS. Additionally, PMCF should be considered a part of the evidence lifecycle—not an activity to be completed or thought about after the CER is completed. The PMCF strategy and findings can affect the ongoing clinical evaluation, risk assessment, and other parts of the technical documentation.

CER conclusions should therefore be clear, evidence-based, traceable, and easy to verify. Avoid broad statements such as “the device is safe and effective based on the available literature”, or “the device has been on the market for many years”. Instead, demonstrate which evidence supports each relevant claim, identify remaining limitations transparently, explain how risks are controlled, and justify why the overall evidence is sufficient for the intended purpose.

Evidence-Based Approach for Global Regulatory Submissions

Global medical device regulatory requirements share an important principle: regulatory decisions depend on the quality, relevance, and totality of evidence supporting the safety and effectiveness of a device. The key question is:

“Does the totality of evidence, considered in the context of the specific device in question, adequately demonstrate that its benefits outweigh its risks and support its intended clinical use?”

Getting that answer right—clearly, consistently, and transparently—is the foundation of a defensible CER.

Developing a coherent evidence strategy early can help reduce unnecessary duplication while maintaining jurisdiction-specific requirements. Early alignment of clinical claims, evidence generation, risk management, and regulatory strategy can also make subsequent submissions more efficient.

Proactive Compliance-Focused Approach Matters

Getting a CER right the first time requires more than strong medical writing. It requires a compliance-focused clinical and regulatory strategy and data interpretation from experts who understand how the Notified Body will review your CE submission and can identify evidence gaps before they become submission-stage deficiencies. Structured gap assessments, claim-to-evidence mapping, traceability reviews, benefit-risk alignment, and mock notified body reviews can further strengthen the submission package.

For MedTech companies operating under demanding timelines, this proactive approach can mean fewer review cycles, more predictable regulatory interactions, reduced approval risk, and shorter time-to-market.

Strengthen Your CER Before Notified Body Review

A successful CER requires more than strong medical writing. It requires a clear understanding of the device, a defensible clinical evidence strategy, rigorous scientific appraisal, and consistency across the broader technical documentation.

Celegence supports medical device manufacturers across clinical evaluation strategy, CER and CEP development, systematic literature reviews, evidence gap assessments, PMS and PMCF, risk-document alignment, and Notified Body responses.

Our approach combines experienced regulatory and clinical professionals with purpose-built technology to accelerate evidence-intensive activities while keeping clinical interpretation and regulatory judgment with qualified experts.

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