Notified Body questions on clinical evaluation do not always arrive as a surprise. Most CERs that attract scrutiny show recognisable patterns — gaps in evidence logic, missing connections between documents, or structural problems that experienced reviewers flag quickly. Identifying these signs early allows remediation before formal comments arrive.
1. The state-of-the-art section describes the technology but not your device's clinical performance
A state-of-the-art section that catalogues the published literature on a device category without positioning your device's clinical data within it is one of the most common CER weaknesses. Notified Bodies look for a clear clinical story: what does the evidence say about the intended purpose of devices like yours, and how does your device's clinical performance compare?
If your SOTA reads as a standalone literature review rather than a framework for evaluating your device's benefit-risk profile, expect questions about how the literature was selected, why certain evidence was excluded, and how the SOTA conclusions support your benefit-risk write-up.
2. Benefit-risk conclusions are not traceable to specific clinical data
A benefit-risk section that states "the clinical benefits outweigh the residual risks" without referencing the specific data that supports that conclusion will almost always attract a comment. Notified Body reviewers look for a logical chain: identified clinical benefits, supporting clinical data, quantified or qualified residual risks, and an explicit comparison.
Where the benefit-risk section summarises existing sections of the CER without adding new reasoning, reviewers often flag it as circular. The conclusion should explain why the balance holds, using data cited elsewhere in the CER — not simply assert that it does.
3. Post-market data is not reflected in the CER's clinical conclusions
EU MDR requires post-market clinical follow-up to inform the clinical evaluation on an ongoing basis. A CER that was last substantively updated before significant PMCF or PMS data was generated — or that acknowledges post-market data in an appendix without integrating it into the benefit-risk analysis — will likely receive questions about whether the conclusions still hold.
Check that your PMCF Evaluation Report findings, complaint data, and any updated literature are reflected in the CER's state-of-the-art review, clinical data section, and benefit-risk conclusions. Disconnected documents are a consistent Notified Body flag.
4. Intended purpose and claims are inconsistent across the technical file
CERs that define the intended purpose or clinical claims differently from the IFU, risk management file, or device description create immediate consistency questions. Notified Bodies cross-reference these documents. If the CER evaluates evidence for a broader population or indication than the IFU specifies — or if a clinical claim appears in the CER but not in the risk management file as a residual benefit — reviewers will ask for clarification or correction.
Before submission, map every claim and intended purpose statement in the CER to its corresponding entry in the IFU and risk management documentation. Inconsistencies are straightforward to resolve before submission and time-consuming to explain after.
5. The CER follows an MDD-era structure rather than MDR requirements
A significant number of CERs in circulation were written to satisfy MDD requirements and incrementally updated since. These documents often lack the structured clinical evaluation plan, the explicit SOTA methodology, or the level of benefit-risk reasoning that MDR and MEDDEV 2.7/1 revision 4 require. Notified Bodies reviewing these CERs frequently identify structural deficiencies that cannot be resolved by adding sections — the document needs to be reconsidered from the evaluation plan level.
If your CER does not contain an explicit Clinical Evaluation Plan, or if its structure does not follow the MEDDEV 2.7/1 rev 4 framework, it is worth assessing whether the document needs a remediation rather than an update.
Acting on these signs before submission
None of these gaps require a complete CER rewrite to address. A documentation gap review — mapping the specific weaknesses in your current CER against MEDDEV 2.7/1 rev 4 requirements — is usually the most efficient starting point. It allows you to prioritise remediation effort, identify which gaps carry the most review risk, and plan the work before formal submission or renewal.