Insight · EU MDR · Clinical Evaluation
A Clinical Evaluation Report (CER) sets out the conclusions of a device's clinical evaluation: the evidence that demonstrates its safety, performance and regulatory compliance. Under EU MDR 2017/745, that evidence is scrutinised more closely than ever. This guide explains the clinical evaluation process and the six-part structure of the CER, with guidance on writing a report a Notified Body will accept.
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CERs under MEDDEV 2.7/1 Rev 4 and EU MDR, and responses to Notified Body nonconformities.
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Evidence, not adjectives
Why the CER is decisive
The European regulatory landscape has changed significantly over the past decade, driven in part by a series of device failures that fed a perception, among regulators and clinicians alike, that the clinical evidence for medical devices was not scrutinised closely enough in Europe. EU MDR 2017/745, issued by the European Parliament and the Council of the European Union, responds with a higher, continuously maintained bar for evidence.
The MDR requires a report on the safety and performance of the device, built around the General Safety and Performance Requirements (GSPR) and presenting the clinical evidence derived from the appraisal of clinical data. The CER must be kept up to date throughout the device's commercial life. The precise requirements are detailed in the MDCG guidance documents, notably MDCG 2020-5, 2020-6, 2020-13, 2021-6, 2019-9 rev.1, 2022-21 and 2023-3. To go further, see our clinical evaluation (CER) methodology.
The clinical evaluation process
Annex XIV of the EU MDR sets out the requirements of the clinical evaluation process. They are broadly consistent with the process described in the AIMDD and MDD directives and developed in the MEDDEV 2.7/1 Rev 4 guidance: planning, data collection, data appraisal, generating data where necessary, analysis and conclusions, then ongoing data collection in the post-market phase to maintain and update the evaluation.
Although this sequence is often depicted step by step, in practice interactions create feedback loops within the cycle.
The six parts of a CER
The length of the document depends on the risk the device poses to a patient: potentially more hazardous products call for a more detailed report. Whatever the length, the structure stays the same.
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The first section is a solid overview of the entire report. It should state the intended target groups, the medical indications and a list of the product's possible benefits and risks, along with the conclusion of the medical evidence on its effectiveness. An assessor should be able to read this section alone and understand the case that the rest of the CER develops.
To include
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This section covers the technical and clinical aspects, clearly explaining the technology and the way the device works. Details such as the model, size, software version where applicable and the accessories available should be stated. The description is where a Notified Body first checks that the device you evaluated is indeed the one you are placing on the market.
To include
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Every evaluation report requires thorough research into the clinical context in which the product is used. The sources and research methods should be explained, along with any standards or guidance that may affect the device. The medical conditions and their frequency in the general or target population should also be included. This is the state of the art (SOTA) against which the device is judged.
To include
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The clinical evidence section is one of the most important parts of the report. This is where you present the studies and data that support the device's use and effectiveness. It should tie directly to the claims made in the scope and to the state of the art established in the clinical background. See also our PMCF surveys.
To include
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Next, you analyse the device's potential benefits for patients against the associated risks. You may also compare these benefits and risks with those of other existing devices or treatments. A defensible benefit-risk conclusion draws on the data cited above; it is not asserted on top of it.
To include
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Finally, you conclude the CER by summarising the main findings. You may restate the device's benefits and risks and its compliance with regulatory requirements. Note that these requirements can vary from one country to another: if you are preparing a CER for a specific market, consult the guidance and requirements particular to that country.
To include
The process at a glance
Examples of interactions that turn a linear sequence into a cycle: a state-of-the-art appraisal may call for a revision of the risk analysis before any further data collection; the appraisal stage may reveal that the literature is insufficient to feed the analysis, requiring a revision of the Clinical Evaluation Plan (CEP); and the conclusions may require additional preliminary studies or a change in the indications for use.
From nonconformity to a defensible dossier
Writing a compliant CER is complex and demanding. Our clinical and regulatory experts turn nonconformity letters into defensible responses, and thin evidence into a report that holds. See how we run post-market clinical follow-up (PMCF).
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