Common Non Conformities in MDR Clinical Evaluation

• CER and CEP files are not fully searchable or easy to navigate
• There is no clickable table of contents or bookmarks in long PDFs
• Updated documents are sent without a tracked changes version
• Final signed versions of key documents are missing at module closure
• The CER does not clearly state the primary regulatory approach for the clinical evaluation
• Author CVs and DOIs are missing, unsigned, or out of date
• The gap between literature search cut off and submission is too long for higher risk devices

• Make every CER and CEP fully searchable with clickable contents and bookmarks
• Always submit tracked and clean versions together, with a two line change note
• Add a short Pathway Statement in section one

Example
“This clinical evaluation is based on clinical data from literature and manufacturer generated investigations supported by PMS and PMCF. No equivalence route is used. Article sixty one point ten is not applied.”

• Keep a small Author Dossier in the appendix with signed CVs and current DOIs
• Align your literature search cut off with device risk and the pace of state of the art changes

• Multiple models included in one CER without clear model level support
• Evidence pooled across sizes or indications with no explanation
• Worst case or highest risk variants used without scientific justification
• Claims written as family wide when evidence supports only specific models
• No device family map linking each model to the supporting data

• Build a Device Family Matrix listing each model size configuration intended use and the evidence that supports it
• If using a highest risk model provide a short bridging justification showing why it represents the other variants using preclinical and clinical comparisons
• Mark every clinical claim as Family level or Model specific
• When a model lacks direct data explain how bridging similarity testing or limited equivalence supports it

• Intended purpose statement is vague and not certificate ready
• Indications and contraindications are incomplete or scattered across documents
• Clinical benefits are written as general intentions, not measurable outcomes
• No clear link between benefits and outcome parameters
• Benefit risk acceptance thresholds are missing or not taken from the state of the art
• The CEP and CER are not aligned on the outcomes used to judge success

• Write one clear intended purpose statement that you would be comfortable printing on the certificate
• List intended patient groups and intended users in simple language in the CEP and ensure they match the IFU
• Convert each clinical benefit into one or more measurable outcomes
• Define acceptance thresholds for performance and safety based on the state of the art and copy them into the CEP
• Ensure the CER uses the same outcomes and thresholds when presenting device data
• For low risk devices where numbers are harder to set explain clearly how you will still judge whether the device does what you claim

• The state of the art section reads like a textbook chapter rather than a focused evidence review
• Alternative treatment options are listed but not compared in a structured way
• Safety and performance outcomes from the literature are described narratively, not turned into numbers
• No explicit acceptance ranges are defined for key outcomes
• The CEP does not reuse these ranges as thresholds so the CER cannot make direct comparisons
• For legacy devices, the file does not clearly show how newer alternatives have evolved and what that means for benefit risk

• Keep the medical background short and create a separate focused state of the art section
• Identify the main alternative treatments and summarize their key safety and performance outcomes in a small table
• Turn those outcomes into numeric ranges or clear qualitative thresholds that you will use as acceptance criteria
• Copy these thresholds into the CEP so they become the planned benchmarks for the device
• In the CER compare your device data directly against these thresholds and state clearly whether you meet them or where you differ and why
• For legacy devices show how newer alternatives influence what is now an acceptable benefit risk balance

• Only one scientific database is searched
• Search strategy and filters are not fully documented
• Excluded studies are marked as “not relevant” with no reason given
• Appraisal terms like high, medium, low quality are used without device specific definitions
• No separation of evidence for the device under evaluation, equivalent devices, and the state of the art
• The final number of included studies in each evidence group is not clearly stated
• Full text copies of included studies are not available for review

• Use more than one scientific database that fits your clinical field
• Document the full search strategy, including dates and filters, in a repeatable format
• For every excluded paper provide a short reason such as wrong population, wrong device, or wrong endpoint
• Define in advance what long enough follow up means for your device and what clinically significant means for your claims
• Rate each study using these device specific criteria and classify studies as pivotal or supportive
• Keep separate lists for the device under evaluation, equivalent or similar devices, and the state of the art
• Ensure full text copies of all included papers are available for the reviewer

• No clear justification when a clinical investigation has not been performed
• Pivotal studies conducted outside the Union with no formal gap analysis
• Studies not aligned with ISO 14155 or MDR Annex fifteen without discussion of limitations
• No explanation of how population differences, practice patterns, or follow up influence transferability
• Missing summaries of authority interactions for MDR related studies including approvals, conditions, or refusals

• When no clinical investigation is performed provide a clear point by point rationale explaining why the existing evidence is sufficient
• For studies conducted outside the Union prepare a simple gap analysis comparing study setting, population, practice, and follow up to European use and explain the impact on transferability
• For studies not aligned to ISO 14155 or MDR Annex fifteen describe the main deviations and their implications for data quality and bias
• State clearly which study results you consider pivotal and which are used only as supportive
• Summarise the key outcomes of authority correspondence for MDR related investigations including decisions major questions and how they were addressed

• PMS sections show narrative comments but no yearly volumes or trends
• PMCF plans rely only on literature even when the device has substantial market history
• PMCF endpoints do not match the benefit and safety outcomes set in the CEP
• Sample sizes and timelines for PMCF activities are not stated
• Serious incidents, FSCAs, recalls, reportable events, and CAPAs are not clearly summarised
• Links between PMS and PMCF findings and CER updates are not described

• Report sales volumes by year and main markets so trends can be seen
• Show total complaints and key complaint categories by year
• List severe adverse events, deaths, FSCAs, recalls, reportable events, and CAPAs in a simple table
• Run queries in the main vigilance databases and write a short summary of what you found
• In the PMCF plan define sample sizes, timelines, and endpoints that match the benefit and safety outcomes in your CEP
• Explain how and when PMCF results will be reviewed and used to update the CER and SSCP
• If PMCF is not applicable for a specific device give a clear rationale and describe how PMS activities and literature surveillance will still update the clinical picture

• Marketing and website claims are not backed up by analysis in the CER
• The SSCP lists risks but does not give quantitative figures or relate them to time
• The patient section of the SSCP is missing even though it is required
• Lifetime information for implants is unclear or not included where it should be
• New claims appear in brochures that are not reflected in any clinical document

• Build a simple claims matrix that lists every external claim and points to supporting analysis and references in the CER
• In the SSCP provide quantitative risks and link them to time, for example early and late events or per patient year
• State success rates for key outcomes in the SSCP using clear numbers taken from the CER
• Include a patient friendly SSCP where it is required and check that the language matches the main clinical messages
• For implants describe the expected lifetime in line with the legal basis, the risk analysis, and the available clinical and preclinical data
• When new claims are added in marketing update the claims matrix and check that the CER and SSCP still support them

• Residual risks and device specific adverse events do not match across the IFU, CER, and risk management file
• New risks identified in clinical data are not carried through into the risk management documentation
• Contraindications and warnings appear in the IFU without a clear link to the underlying risk evaluations
• There is no visible evidence that someone with clinical expertise has contributed to the risk management process
• Trend information from PMS and PMCF is not used to review and update risk estimates

• Cross check that every device specific adverse event seen in clinical data appears consistently in the IFU, the CER, and the risk management file
• When a contraindication or warning is added in the IFU record it as a risk control in the risk report and explain how it reduces the residual risk
• Ensure at least one person involved in risk management has clinical experience with the device and include a short CV in the file
• Use PMS and PMCF findings to review and adjust risk estimates and document the outcome of that review
• Add a short alignment table listing key risks, associated adverse events, risk controls, and where they are described in the IFU and CER