How can manufacturers ensure Clinical Evaluation Reports (CERs) meet the expectations of Notified Bodies (NBs) under EU MDR?

Understanding Clinical Evaluation Reports (CERs) in EU MDR

Definition and Purpose of Clinical Evaluation Reports (CERs)

A Clinical Evaluation Report (CER) is a critical technical document required under the European Union Medical Device Regulation (EU MDR 2017/745). It provides a structured presentation of clinical data to demonstrate that a medical device is safe, performs as intended, and that its benefits outweigh any associated risks when used under normal conditions. The CER is based on a process called clinical evaluation, which includes the collection, appraisal, and analysis of clinical data throughout the lifecycle of the device. Unlike previous practices under the Medical Device Directive (MDD), MDR emphasizes continuous evaluation rather than a one-time report at market entry.

Legal Basis and Regulatory Framework

Under MDR, the legal basis for clinical evaluation is defined in Article 61 and further detailed in Annex XIV, Part A. This regulatory framework sets stringent requirements for both the process and content of clinical evaluations. Additionally, the MDR introduces significant changes compared to the MDD, including stricter criteria for clinical evidence, clearer definitions of equivalence, and an obligation to maintain the CER as a living document. Supporting guidance such as MEDDEV 2.7/1 revision 4 and MDCG documents (e.g., MDCG 2020-13, 2020-6, and 2021-6) provide practical methodologies and templates to meet these requirements.

Scope and Applicability

The CER requirement applies to all medical devices under MDR, regardless of their class. However, the depth and breadth of clinical evaluation vary depending on the device’s classification, novelty, and risk profile. High-risk devices such as Class III or implantable devices require direct clinical investigations or substantial clinical data from the device itself. Lower-risk devices may rely more heavily on published literature or equivalence, provided stringent criteria are met. Importantly, even legacy devices (previously CE marked under MDD) are subject to MDR’s enhanced CER requirements if they continue to be marketed.

Components of a Comprehensive CER

A complete and compliant CER must include several key components. These typically include a description of the device and its intended use, a definition of its clinical claims, a summary of clinical data sources, a critical evaluation of relevant literature, an analysis of clinical performance and safety, and conclusions on the benefit-risk ratio. The CER should also integrate findings from the device’s post-market surveillance (PMS) and post-market clinical follow-up (PMCF) activities, ensuring that the document reflects real-world data and ongoing clinical experience. For higher-risk devices, it must also reference the Summary of Safety and Clinical Performance (SSCP).

Integration with Other Technical Documentation

The CER does not exist in isolation; it must be fully aligned with other elements of the device’s technical documentation. This includes the risk management file (as per ISO 14971), the instructions for use (IFU), design dossiers, PMS reports, and labeling. Inconsistencies between the CER and these documents are a common cause of non-compliance during notified body audits. Manufacturers must ensure that risk-benefit conclusions in the CER are reflected in the risk file and that clinical claims match those presented in the IFU. This holistic integration reinforces the MDR’s emphasis on coherence and lifecycle management.

Living Document and Lifecycle Approach

One of the most critical shifts introduced by EU MDR is the transformation of the CER into a living document. This means the CER must be regularly updated throughout the device’s lifecycle—not just during initial CE marking. Updates are triggered by significant changes in clinical evidence, new risk findings, modifications to the device, or outcomes from PMS/PMCF activities. For some devices, particularly Class III and implantables, annual updates may be required. This continuous approach ensures that the CER remains current and reflective of the device’s clinical performance over time.

Under EU MDR 2017/745, Clinical Evaluation is a continuous, systematic process to collect, appraise, and analyze clinical data for verifying the safety and performance of a medical device throughout its lifecycle.
It culminates in the Clinical Evaluation Report (CER) – a foundational document reviewed during conformity assessments by Notified Bodies.

Regulatory Requirements for CERs under EU MDR

Legal Basis for Clinical Evaluation under MDR

The Clinical Evaluation process under the EU Medical Device Regulation (MDR 2017/745) is formally governed by Article 61 and Annex XIV, Part A. These sections mandate that manufacturers must plan, conduct, and document a clinical evaluation to demonstrate the conformity of a device with relevant safety and performance requirements throughout its expected lifetime. Unlike the earlier Medical Device Directive (MDD 93/42/EEC), which provided more general guidance under Annex X, the MDR introduces stricter, more detailed, and enforceable obligations. These include a greater emphasis on scientific rigor, ongoing clinical data generation, and lifecycle integration. The Clinical Evaluation Report (CER) must synthesize findings from this structured process and form part of the technical documentation required for CE marking.

Emphasis on Clinical Data and Lifecycle Approach

Under MDR, the reliance on purely literature-based evidence has become insufficient for most devices. Clinical Evaluation Reports must be backed by robust clinical data, including clinical investigations, post-market clinical follow-up (PMCF), and real-world data. For Class III and implantable devices, clinical investigations are generally required unless justified otherwise. MDR enforces a lifecycle approach, requiring manufacturers to update CERs regularly based on new safety and performance data. This marks a significant shift from the previous approach under MDD, where clinical evaluations were often only updated at the time of re-certification or major design changes.

Equivalence Criteria under MDR

The use of clinical equivalence — a practice heavily relied upon under MDD — has become far more restricted under MDR. To claim equivalence, manufacturers must demonstrate clear technical, biological, and clinical similarity between their device and the comparator device. Furthermore, they must have full access to the technical documentation of the equivalent device. This makes equivalence claims extremely challenging, especially when the comparator device is from another manufacturer. The stricter equivalence criteria aim to ensure that clinical claims are directly applicable to the subject device, minimizing uncertainty and improving patient safety.

Role of Post-Market Surveillance and PMCF

MDR requires manufacturers to integrate data from Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) into their CERs. The CER must reflect a continuous clinical evaluation that is informed by real-world device use, adverse events, complaints, and emerging risks. For many device types, PMCF studies are now mandatory and must follow a documented PMCF plan. The MDR Annex XIV, Part B outlines specific expectations for PMCF, making it an integral part of the clinical evaluation process. This requirement ensures that the device remains safe and effective even after it enters the market.

Alignment with Other MDR Documentation

The CER must be consistent with other elements of the device’s technical documentation, including the risk management file, labeling and Instructions for Use (IFU), and — for Class III and implantable devices — the Summary of Safety and Clinical Performance (SSCP). Any discrepancy between these documents can lead to negative conformity assessments. Notified Bodies often cross-reference these files during their reviews, so manufacturers must ensure that all data, especially regarding intended purpose, indications, contraindications, and residual risks, are harmonized across documentation. This alignment is critical to presenting a credible and compliant regulatory dossier.

Structured Documentation and Presentation

To meet MDR requirements and satisfy Notified Bodies, the Clinical Evaluation Report must be prepared in a structured, methodical, and transparent format. This includes a clearly defined clinical evaluation plan, methodology for identifying and appraising clinical data, and a well-justified conclusion based on the totality of evidence. Guidance documents such as MEDDEV 2.7/1 rev. 4, although based on MDD, still serve as foundational references for structuring CERs. Additionally, the MDCG 2020-13 template provides a standardized format that helps manufacturers align their CER content with Notified Body expectations. A well-organized CER helps demonstrate due diligence and makes the conformity assessment process more efficient.

Aspect	MDD (Old Directive)	MDR (New Regulation 2017/745)
Legal Basis	Annex X (MDD 93/42/EEC)	Annex XIV Part A & Article 61
Evidence Expectations	Could often use literature alone	Requires clinical data, especially for implantables and Class III
Equivalence Use	Often used broadly	Strict criteria (clinical, biological, technical similarity)
Lifecycle Approach	One-time, at launch	Continuous update throughout lifecycle
Post-Market	Not mandatory	Must include PMCF, PMS, vigilance data

Key Regulatory Guidance:

MDCG 2020-13: Clinical Evaluation Assessment Template

MDCG 2020-6: Clinical Evidence needed for legacy devices

MDCG 2021-6: Sufficient Clinical Evidence

MEDDEV 2.7/1 rev. 4 (still referenced as a best practice)

What Notified Bodies Expect in CERs

1. Sufficient and Robust Clinical Evidence

Definition and Regulatory Foundation

Sufficient and robust clinical evidence refers to the quantity and quality of clinical data required under the EU MDR (Regulation 2017/745) to demonstrate that a medical device consistently performs as intended, without posing unacceptable risks to the patient or user. This concept is rooted in Article 61 and Annex XIV, Part A of the MDR, which emphasize the need for well-documented, scientifically valid clinical evaluation based on data generated from clinical investigations, post-market surveillance (PMS), post-market clinical follow-up (PMCF), and the existing scientific literature. The evidence must justify the device’s claimed intended use, clinical benefits, and benefit-risk profile throughout its lifecycle.

Scope of Clinical Evidence Required

Under MDR, the scope of clinical evidence goes beyond pre-market clinical trials or studies. It encompasses a combination of clinical investigations (especially for Class III and implantable devices), real-world data, published literature, PMS reports, and PMCF findings. For higher-risk devices, the expectation is for direct clinical evidence on the device itself, not surrogate data. For lower-risk or legacy devices, robust justification is required to explain why new clinical investigations may not be necessary, and how existing data meet the sufficiency threshold. The evidence must be device-specific, relevant to the population and indication, and reflective of current medical practice.

Key Characteristics of Robust Clinical Evidence

Robust clinical evidence is characterized by scientific validity, reproducibility, relevance, and traceability. It must be gathered through well-designed methodologies — such as randomized controlled trials (RCTs), prospective observational studies, or real-world registries — with clearly defined endpoints, risk mitigation measures, and data integrity protocols. Data must be appraised for quality, completeness, and bias, ensuring that both positive and negative outcomes are transparently addressed. The strength of the evidence is also evaluated in terms of statistical significance, clinical relevance, and sample size adequacy.

Use of Clinical Data Sources

Manufacturers must utilize a diverse set of clinical data sources to establish a comprehensive evidence base. This may include internal clinical investigations, externally published clinical literature, adverse event databases, PMCF surveys, and patient registries. However, reliance solely on literature or third-party data is increasingly scrutinized. Where equivalence is invoked (comparing to another marketed device), MDR requires stringent demonstration of technical, biological, and clinical similarity — alongside documented access to the data of the equivalent device. In most cases, the notified body expects primary, device-specific clinical data to support key performance and safety claims.

Notified Body Expectations and Evaluation Criteria

Notified Bodies assess sufficiency of clinical evidence through a structured evaluation of the Clinical Evaluation Report (CER). They expect the clinical evidence to directly support the device’s intended purpose, indication, and target population. CERs must include critical analysis of how the evidence supports the device’s conformity with the General Safety and Performance Requirements (GSPRs). This includes thorough comparisons with the state of the art, clearly documented clinical endpoints, and integration of post-market findings. Any gaps must be acknowledged and addressed through future PMCF activities, which must be proportionate to the device risk and clinical uncertainty.

Common Pitfalls and Rejection Triggers

CERs often fail when the clinical evidence is outdated, irrelevant, insufficiently appraised, or lacks transparency. A frequent issue is over-reliance on literature reviews without adequately structured methodologies or without linking the findings to the specific design and performance characteristics of the device. Similarly, insufficient or poorly justified equivalence claims and lack of device-specific PMCF data are red flags for notified bodies. Clinical data that do not align with the risk management file or the device’s intended clinical benefit are likely to be rejected or lead to extended review timelines and additional questions.

Lifecycle Approach to Evidence Generation

EU MDR mandates that clinical evidence generation is not a one-time event but a continuous process throughout the device lifecycle. Manufacturers must implement mechanisms for ongoing clinical data collection, analysis, and integration into the CER through PMCF and PMS activities. This continuous feedback loop ensures that the evidence base remains up-to-date and reflective of the device’s actual performance and safety in the real world. Lifecycle data collection also enables early identification of emerging risks, changes in clinical practices, and potential improvements to device design or instructions for use.

Device-specific data preferred over broad literature.
Must show clinical benefit, state-of-the-art comparison, and positive benefit-risk ratio.
Real-world evidence and PMCF outcomes are expected to complement pre-market data.

2. Proper Use of Equivalence

Definition and Importance of Equivalence

Under the EU MDR (2017/745), clinical equivalence is a method by which a manufacturer can demonstrate the safety and performance of a medical device by referring to clinical data from a comparable device already on the market. This approach was more commonly used under the previous MDD framework but is still permissible under MDR—albeit with significantly stricter requirements. Proper use of equivalence is critical when a manufacturer lacks sufficient clinical data from their own device, especially for legacy or low-risk devices transitioning to MDR compliance.

The Three Pillars of Equivalence: Clinical, Technical, and Biological

The MDR mandates that manufacturers must demonstrate equivalence in three distinct areas: clinical, technical, and biological characteristics. Clinical characteristics include intended purpose, indications, target population, and clinical performance. Technical characteristics refer to design, specifications, performance parameters, and modes of action. Biological characteristics involve the materials and substances that come into contact with the body and their compatibility with tissues. All three aspects must be proven to be essentially similar for equivalence to be accepted. Notified Bodies scrutinize this section rigorously, and the burden of proof lies entirely with the manufacturer.

Full Access to the Equivalent Device’s Data

One of the most significant changes under MDR is the requirement that manufacturers must have full access to the technical documentation of the equivalent device. This includes access to the risk management file, design dossier, and clinical evaluation documentation of the comparator product. If such access is not available—especially for a competitor’s device—equivalence cannot be claimed. This requirement has severely limited the ability of manufacturers to rely on competitor products for equivalence, unless a contractual agreement or company affiliation allows for data sharing.

Documentation and Justification Requirements

To demonstrate equivalence, manufacturers must provide a detailed, side-by-side comparison that clearly outlines how the device under evaluation and the comparator device meet each of the three equivalence criteria. This is usually presented in a structured tabular format, supported by bibliographic references, regulatory filings, and certificates. The justification must also explain why the existing clinical data from the equivalent device is relevant and sufficient to support the safety and performance of the new device. Vague claims or general similarities are not acceptable; the documentation must be precise, well-referenced, and scientifically defensible.

Limitations and Risk-Based Considerations

The use of equivalence is highly restricted for high-risk devices, especially implantable or Class III devices, unless the manufacturer owns both devices or has access to comprehensive data. For lower-risk devices, the Notified Bodies may accept equivalence more readily, provided the evidence is complete and well-documented. However, in all cases, the risk-benefit profile of relying on equivalence must be justified as part of the Clinical Evaluation Report. Manufacturers are also encouraged to consider generating their own clinical data, especially if long-term market presence, device changes, or expanded indications are anticipated.

Conclusion and Strategic Recommendations

While the equivalence route remains a viable pathway under MDR, its use has become far more limited and complex. Manufacturers intending to use this strategy must plan early, secure access to comprehensive data, and ensure alignment with the latest guidance documents such as MEDDEV 2.7/1 rev. 4 and MDCG 2020-5. It is often more sustainable, especially for high-risk devices, to invest in generating proprietary clinical data through Post-Market Clinical Follow-up (PMCF) studies or investigator-led research. Properly documented equivalence, when used correctly, can still serve as a strong foundation for regulatory compliance and successful Notified Body review.

Must demonstrate technical, biological, and clinical equivalence to comparator device.
The manufacturer must:
- Have full access to the equivalent device’s data.
- Justify each equivalence point with traceable, documented comparison.

3. Critical Evaluation of Data

Importance of Critical Evaluation in CERs

Critical evaluation of clinical data is a cornerstone of the Clinical Evaluation Report (CER) under the EU MDR. It involves more than simply compiling literature or summarizing clinical studies; it requires a rigorous and transparent appraisal of the relevance, quality, and significance of each piece of clinical evidence. The manufacturer must demonstrate that all data considered are both scientifically valid and clinically relevant to the device being evaluated. Notified Bodies expect this evaluation to be systematic, objective, and clearly linked to the device’s intended purpose, risk profile, and performance claims.

Quality Assessment of Clinical Data Sources

Every data source used—be it clinical trials, real-world evidence, scientific publications, or registry data—must be critically appraised for methodological quality. This includes evaluating the study design (e.g., randomized, observational), sample size, patient demographics, statistical robustness, bias control, and outcome measures. Manufacturers must provide justification for the inclusion of each study and clearly explain how its findings contribute to the safety and performance conclusions. Poor-quality or biased studies should be excluded or weighted appropriately, with rationale documented transparently.

Relevance to the Device and Intended Use

Not all clinical data are equally applicable to a given device. The data selected must be relevant in terms of patient population, clinical indication, anatomical site, duration of use, and intended performance. The evaluation must explicitly link these parameters to the device under assessment. For instance, using data from a different anatomical application or from a substantially modified design may not be acceptable unless clear equivalence is established. This relevance filter is critical to ensure that clinical conclusions drawn are specific, valid, and support regulatory claims.

Data Synthesis and Comparative Evaluation

A strong CER does not just present individual data points but also integrates them into a comparative narrative. This synthesis should explain how the device’s safety and performance compare to the state of the art and to any equivalent devices, if claimed. The manufacturer must identify trends, common findings, or contradictory results, and then discuss their significance. This comparative analysis must also be aligned with other technical documents like the risk management file and the Summary of Safety and Clinical Performance (SSCP).

Addressing Gaps, Limitations, and Residual Risks

A critical evaluation must acknowledge the limitations and uncertainties within the available clinical data. Manufacturers should identify any data gaps, such as limited long-term follow-up, underrepresentation of certain patient groups, or incomplete adverse event reporting. These limitations must then be linked to the Post-Market Clinical Follow-up (PMCF) plan or other measures designed to address them. Moreover, the evaluation must explain how the residual risks identified are acceptable in light of the clinical benefits and alternative treatments, reinforcing the benefit-risk justification required under MDR.

Consistency with Risk Management and PMS

Finally, the conclusions drawn from critical data evaluation must be consistent with the device’s risk management file and post-market surveillance (PMS) findings. This means that all identified risks, complications, or adverse events must have a clear clinical basis supported by data. If new hazards or performance issues are identified in the literature or clinical data, they must be reflected in the risk analysis and mitigation strategies. Inconsistent or disconnected analysis across the CER, PMS, and risk documents is a common reason for negative Notified Body findings and must be avoided through integrated and consistent reporting.

Not just listing literature — but systematic literature review, with:
- Inclusion/exclusion criteria,
- Bias assessment,
- Summary tables, and
- Conclusions tied to safety/performance objectives.

4. Integration of Post-Market Data

Definition and Role of Post-Market Data in CERs

Under the EU MDR, post-market data refers to all information gathered after a medical device has been placed on the market. This includes data collected through Post-Market Surveillance (PMS), Post-Market Clinical Follow-up (PMCF), vigilance reports, user feedback, complaints, and adverse event records. Integration of this data into the Clinical Evaluation Report (CER) is a mandatory component of the continuous clinical evaluation process. The intent is to ensure that the CER remains a living document, reflecting the device’s real-world safety and performance throughout its lifecycle.

Post-Market Surveillance (PMS) Contributions

Post-Market Surveillance provides broad observational data on how the device performs under routine clinical use. This includes any non-serious or minor issues reported by users or healthcare providers. The CER must clearly describe how PMS data was collected, analyzed, and used to verify or challenge earlier assumptions about safety, performance, and benefit-risk ratios. Manufacturers must also show how PMS activities align with their PMS Plan and how this data feeds into corrective actions, labeling updates, or clinical recommendations.

Post-Market Clinical Follow-up (PMCF) Relevance

PMCF is a specific subset of PMS and is more structured. It involves actively gathering clinical data to address residual risks, confirm safety and performance, or fill evidence gaps identified during pre-market assessment. PMCF activities might include observational studies, clinical registries, patient surveys, or follow-ups with users. The results must be integrated into the CER with a clear explanation of methodology, sample size, duration, and outcomes. A robust PMCF section within the CER demonstrates ongoing vigilance and regulatory commitment to risk management.

Incorporation of Vigilance Data

Vigilance data refers to serious incidents, Field Safety Corrective Actions (FSCAs), and other reportable events. This information must be analyzed in the CER to assess patterns, frequency, and potential impact on the benefit-risk profile. If recurring issues are found, the CER should explain what steps were taken, such as design modifications, training updates, or increased monitoring. The discussion should also highlight whether the vigilance data led to any updates in the Instructions for Use (IFU), technical documentation, or clinical evidence assumptions.

Harmonizing Post-Market Data with Risk Management

The integration of post-market data in the CER is closely tied to the device’s risk management file, typically developed per ISO 14971. Every clinical finding, complaint trend, or safety incident must be cross-checked against known risks and mitigations. The CER should reflect whether any new risks have emerged or if existing risks have escalated. Furthermore, it should show how risk acceptability is maintained based on real-world evidence, and whether any post-market data has led to changes in the risk-benefit conclusion.

Documentation and Traceability Requirements

For post-market data integration to satisfy notified body expectations, traceability is critical. The CER must explicitly cite sources, such as PMS reports, PMCF studies, or vigilance logs, and connect them to the evaluation conclusions. These references must be up to date, complete, and supported by underlying records. Manufacturers are expected to maintain a transparent audit trail, linking data collection to interpretation and final actions taken. Any delay in updating the CER with fresh post-market data may be seen as non-compliance during NB audits.

Frequency and Timing of Updates

EU MDR promotes the concept of a “living” CER. Integration of post-market data is not a one-time event but a recurring task. Depending on the device classification, the CER should be updated at least annually (for Class III and implantables) or every two to five years for lower-risk classes. However, significant changes in post-market performance, emerging risks, or new clinical evidence should trigger an immediate CER update. Timely integration ensures that the device’s benefit-risk profile remains current and reliable.

PMS (Post-Market Surveillance) and PMCF (Post-Market Clinical Follow-up) plans must feed into CER.
Any Field Safety Corrective Actions (FSCA), complaints, and vigilance reports must be analyzed and addressed.

5. Consistency Across Documentation

Importance of Consistency Across Technical Documentation

Consistency across technical documentation is essential to ensure that all regulatory files submitted for EU MDR compliance are aligned and tell a unified, credible story about a device’s safety and performance. Notified Bodies (NBs) rigorously compare the Clinical Evaluation Report (CER) with other elements of the Technical Documentation to verify that there are no contradictions, gaps, or outdated information. Any discrepancies—such as conflicting clinical claims, inconsistent risk assessments, or mismatched data—can trigger additional rounds of questions, delay certification, or lead to outright rejection. Hence, maintaining harmony across documentation is not just a best practice—it is a regulatory expectation under MDR.

Alignment Between CER and Risk Management File

One of the most critical areas requiring consistency is the relationship between the CER and the device’s Risk Management File, developed per ISO 14971. The CER must reflect the same risks identified in the risk analysis and provide clinical evidence that supports how those risks are controlled or mitigated. For example, if a potential complication or failure mode is listed in the risk file but is absent in the CER’s discussion, it signals incomplete evaluation. The CER must also demonstrate that the residual risks are outweighed by the device’s clinical benefits, using real-world data or clinical studies. Thus, risk-benefit conclusions in both documents must be in complete agreement.

Harmonization With Instructions for Use (IFU) and Labeling

CER findings must be accurately reflected in the device’s Instructions for Use (IFU), labeling, and promotional materials. All intended uses, contraindications, warnings, precautions, and clinical claims listed in the IFU must be directly supported by data in the CER. If, for example, the IFU includes an expanded indication not analyzed in the CER, this raises serious red flags with NBs. Similarly, any patient population or clinical condition cited in marketing materials must have backing in the CER and clinical evidence. Ensuring this alignment reduces regulatory risk and supports transparency and safety for end users.

Synchronization With SSCP and PMCF Plans

For Class III and implantable devices, the Summary of Safety and Clinical Performance (SSCP) must be consistent with the CER in every aspect—from clinical indications to residual risks and PMCF findings. Any new data or trends identified in the PMCF process must also be incorporated into updated versions of the CER. Furthermore, the PMCF plan itself must be aligned with the clinical gaps or uncertainties discussed in the CER. For instance, if the CER notes limited long-term safety data, the PMCF plan should directly aim to address that gap through real-world follow-up or registries. This cyclical consistency strengthens the device’s lifecycle management strategy.

Internal Document Control and Change Management

Achieving consistency also requires strong internal document control systems. Manufacturers must establish robust Standard Operating Procedures (SOPs) for drafting, reviewing, and updating technical documentation, ensuring that any change in one document triggers a review of all related files. For example, updates in the risk file due to new complaints or adverse events should automatically initiate a revision of the CER and potentially the IFU. Version control, traceability, and documentation of rationale for changes are critical in demonstrating to NBs that the manufacturer maintains a coherent and well-governed regulatory framework. Without these controls, inconsistencies may emerge unnoticed and lead to regulatory non-compliance.

CER must align with other MDR documents:
- Risk Management File (per ISO 14971),
- IFU/labeling,
- Technical documentation,
- Summary of Safety and Clinical Performance (SSCP – for Class III/implantables).

Common Reasons for CER Rejection by Notified Bodies (per NB audits & MDCG reports)

Lack of Sufficient Clinical Evidence

One of the most common reasons for CER rejection is the absence of adequate clinical evidence specific to the device in question. Many manufacturers attempt to rely solely on outdated literature or clinical data from legacy products without demonstrating direct relevance to the current device’s performance and safety. Under MDR, Notified Bodies expect comprehensive, up-to-date clinical data obtained from clinical investigations, post-market clinical follow-up (PMCF), or well-structured literature reviews. If the evidence does not sufficiently support the intended purpose, indications, and risk-benefit profile, the CER is often rejected.

Inadequate Equivalence Justification

The improper or superficial use of clinical equivalence is another frequent cause of rejection. Under MDR Article 61 and Annex XIV, demonstrating equivalence requires a rigorous, documented comparison across three dimensions: clinical, technical, and biological. Manufacturers must also have access to the full technical documentation of the equivalent device—a requirement often not met, especially when comparing with competitor products. Notified Bodies are now highly critical of weak or generic equivalence claims that lack tabulated comparisons, scientific rationale, or evidence of access to confidential data. Without this, the CER is likely to be considered non-compliant.

Poor Integration of Post-Market Data

A Clinical Evaluation Report that fails to incorporate relevant post-market data—including PMS (Post-Market Surveillance), PMCF, complaints, vigilance trends, and incident data—will almost certainly raise a red flag during NB reviews. MDR requires that clinical evaluation be a continuous process throughout the product’s lifecycle. CERs must demonstrate how post-market findings influence the benefit-risk analysis and safety profile. If PMCF studies are missing, poorly executed, or disconnected from the conclusions of the CER, Notified Bodies will likely issue non-conformities, potentially leading to certification delays or denials.

Outdated or Static Clinical Evaluation Reports

Notified Bodies expect CERs to be “living documents” that are updated regularly based on new clinical data, literature, adverse event reports, and post-market findings. A common cause of rejection is the submission of static or outdated CERs, often created at the time of initial CE marking under the MDD and never revised meaningfully. MDR has introduced a more dynamic and iterative process, and the CER must reflect ongoing evaluations. Not updating the CER following significant changes—such as design modifications, expanded indications, or safety alerts—can result in findings during NB audits.

Inconsistencies Across Technical Documentation

Regulatory reviewers often identify inconsistencies between the CER and other parts of the technical documentation, such as the risk management file, Instructions for Use (IFU), Summary of Safety and Clinical Performance (SSCP), or labeling. If the clinical risks discussed in the CER do not match those in the risk analysis or if the indications for use differ across documents, this discrepancy can compromise the credibility of the entire submission. Notified Bodies expect a harmonized documentation package, and misalignment is frequently cited as a justification for rejection or additional rounds of questioning.

Problem	Description
🔴 Lack of clinical evidence	CERs relying only on old literature or device equivalence with no direct data
🔴 Poor equivalence justification	No full access to data of equivalent device
🔴 Incomplete PMCF integration	No ongoing collection or analysis of real-world clinical performance
🔴 Outdated or static CER	Failure to keep the CER updated with latest PMS/PMCF data
🔴 Inconsistencies	CER content not matching IFU, risk file, or SSCP

Best Practices to Ensure CERs Meet NB Expectations

1. Implement a Robust Clinical Evaluation Process

Establish a Standard Operating Procedure (SOP) for Clinical Evaluation

The foundation of a robust clinical evaluation process lies in creating a well-defined, documented Standard Operating Procedure (SOP) that aligns with the European Union Medical Device Regulation (EU MDR) requirements—specifically, Article 61 and Annex XIV Part A. This SOP should describe the entire lifecycle of clinical evaluation, including planning, identification and appraisal of data, analysis, report writing, periodic updating, and integration with post-market surveillance activities. It must clearly define roles and responsibilities, criteria for data inclusion, processes for handling literature reviews, and protocols for determining clinical equivalence. Adopting a formal SOP ensures consistency, traceability, and compliance across all devices and teams within an organization.

Build a Cross-Functional Clinical Evaluation Team

To ensure the clinical evaluation process is thorough and meets Notified Body expectations, manufacturers must build a dedicated, cross-functional team. This team typically includes clinical experts, regulatory affairs professionals, risk management specialists, and medical writers. Clinical evaluators should be experienced in both the technical aspects of the device and relevant clinical practices, ideally with knowledge of ISO 14155 (clinical investigation standard) and MEDDEV 2.7/1 Rev. 4. The team should work collaboratively to integrate clinical, safety, performance, and risk data, allowing a more comprehensive and accurate Clinical Evaluation Report (CER) that reflects the real-world use of the device.

Plan and Document the Clinical Evaluation Strategy

The clinical evaluation process must begin with a clear, device-specific Clinical Evaluation Plan (CEP). This plan should outline the scope, objectives, methodology, and sources of clinical data to be used. It must describe the criteria for selecting relevant literature, the justification for equivalence (if applicable), the strategy for gathering clinical investigation data, and the integration of PMS and PMCF findings. Proper documentation of the CEP helps demonstrate to Notified Bodies that the manufacturer has a systematic and premeditated approach, rather than an ad hoc or retrospective justification of clinical performance.

Conduct a Rigorous Literature Review

A structured and scientifically valid literature review is a critical part of clinical evaluation. The process should follow PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) principles to ensure transparency and reproducibility. The manufacturer must define search terms, inclusion and exclusion criteria, search strategies across multiple databases (e.g., PubMed, Embase, Cochrane), and document the screening process. All identified literature must be critically appraised for scientific quality and relevance. This data should then be synthesized to support claims regarding clinical performance and safety, or benchmark the device against the current state of the art.

Appraise and Analyze All Clinical Data

Once relevant data is gathered, manufacturers must assess its quality and suitability through objective appraisal tools and frameworks. The clinical evaluation team must evaluate each piece of evidence for methodological soundness, bias, relevance to the device and indication, and alignment with the device’s risk profile. Whether the data comes from clinical trials, scientific literature, or post-market surveillance, it should be analyzed in a way that reflects the benefit-risk profile of the device under normal conditions of use. Clear summaries, comparative analyses, and a rationale for conclusions drawn must be documented to satisfy NB reviewers.

Integrate Clinical Evaluation with Risk Management

The clinical evaluation process must not be siloed—it must be directly integrated with the risk management system as outlined in ISO 14971. The results from the CER should influence the device’s risk assessment, and conversely, the identified risks should be evaluated using real-world clinical data. This bidirectional integration demonstrates to Notified Bodies that safety is actively monitored and managed throughout the device’s lifecycle. Manufacturers should ensure that any new clinical evidence triggers a review and, if necessary, updates to the Risk Management File (RMF), Instructions for Use (IFU), and Summary of Safety and Clinical Performance (SSCP).

Ensure Living Document Status with Regular Updates

The CER is not a static document; under EU MDR, it must be treated as a living document that is regularly updated. For most devices, particularly Class IIa and higher, the CER must be reviewed annually or upon receiving new clinical or safety data. This includes new PMCF results, vigilance reports, recalls, or changes in state of the art. The manufacturer must implement a controlled mechanism to review and update the CER periodically, linking it with PMS and vigilance systems. Notified Bodies are particularly focused on this lifecycle approach, ensuring that the clinical evaluation remains current and reflective of the device’s actual performance in the field.

Adopt a documented SOP aligned with MEDDEV 2.7/1 rev. 4 and MDR Annex XIV.
Designate experienced clinical writers or CER teams with clinical and regulatory expertise.

2. Use Systematic Literature Reviews (SLRs) with Rigor

Importance of Systematic Literature Reviews in CERs

Systematic Literature Reviews (SLRs) are a cornerstone of Clinical Evaluation Reports (CERs) under EU MDR, especially when clinical investigations are limited or when historical data must be leveraged. Unlike narrative reviews, which are often subjective and selective, SLRs follow a rigorous, reproducible methodology designed to minimize bias and ensure transparency. The goal is to identify, appraise, and synthesize all relevant clinical evidence on the safety and performance of the device or an equivalent comparator. For manufacturers, a well-executed SLR is often the deciding factor in whether a CER meets the expectations of Notified Bodies.

Designing a Methodologically Sound Review

A high-quality SLR begins with a clearly defined review protocol. This includes setting focused research questions (typically using the PICO format—Population, Intervention, Comparator, Outcome), specifying inclusion and exclusion criteria, and selecting databases for literature search. Commonly used sources include PubMed, Embase, Cochrane Library, and Scopus. The protocol should also define the time frame of literature to be covered and whether grey literature (e.g., conference abstracts, unpublished studies) will be considered. Transparency at this stage is essential and should be documented in the CER to prove the scientific rigor of the process.

Conducting the Search and Screening Process

Once the protocol is defined, the actual search must be conducted using precise, comprehensive search strings incorporating keywords, MeSH terms, Boolean operators, and filters. It’s critical to record the search date, database, number of records retrieved, and rationale for filtering. The screening process typically involves a two-tier review: title/abstract screening followed by full-text review. To reduce selection bias, this process should ideally be conducted by two independent reviewers with discrepancies resolved through consensus or arbitration. A PRISMA flow diagram is often included in CERs to visually summarize the study selection pathway.

Critical Appraisal and Data Extraction

After identifying relevant studies, each must be critically appraised for methodological quality, relevance, and applicability to the device in question. Tools such as the Cochrane Risk of Bias tool or GRADE may be used depending on study type. Data extraction forms should be standardized to capture study design, patient demographics, intervention characteristics, outcomes, and limitations. Manufacturers must ensure that the extracted data directly support claims of device safety and performance. Studies of poor quality or high risk of bias should be either excluded or discussed transparently in the limitations section of the CER.

Synthesis of Evidence and Documentation

The final step involves synthesizing the findings in a meaningful, structured narrative that aligns with the intended use and risk profile of the device. This can be either qualitative or quantitative (meta-analysis), depending on the homogeneity of the data. The synthesized evidence should support the clinical benefit claims and demonstrate a favorable benefit-risk ratio. The conclusions must clearly explain how the clinical data, including literature, meet the General Safety and Performance Requirements (GSPRs) of the MDR. All steps, decisions, and results of the SLR must be fully documented in the CER, ensuring traceability and reproducibility for Notified Body review.

Use databases like PubMed, Embase, Cochrane.
Follow PRISMA guidelines.
Use tools like EndNote or DistillerSR to manage references.
Report inclusion/exclusion with flow diagrams.

3. Strengthen PMCF and PMS Feedback Loop

Importance of Strengthening the PMCF and PMS Feedback Loop

Under the EU MDR, a critical expectation is the continuous demonstration of a medical device’s safety and performance through a dynamic and integrated Post-Market Clinical Follow-up (PMCF) and Post-Market Surveillance (PMS) system. These systems are not isolated tasks but integral components that provide fresh clinical evidence to support the Clinical Evaluation Report (CER). Strengthening the feedback loop between PMS, PMCF, and the CER ensures that clinical conclusions are based on real-world data and device-specific post-market behavior, which is vital for maintaining conformity and regulatory approval.

Integrating PMS and PMCF into the Clinical Evaluation Lifecycle

The PMS system is designed to systematically monitor the performance of a device after it is placed on the market. PMCF, as a subset of PMS, specifically focuses on proactively collecting clinical data. To strengthen the feedback loop, manufacturers must align PMS plans and PMCF plans with the clinical evaluation process from the beginning. The data collected—such as complaint trends, adverse events, usability concerns, and long-term performance—should be continuously reviewed and assessed to update the CER. This ongoing feedback allows for dynamic clinical risk assessment and more accurate benefit-risk evaluations.

Designing Targeted PMCF Activities for Evidence Generation

Effective PMCF begins with a well-defined plan that outlines the methods for clinical data collection. Manufacturers should move beyond passive data collection methods and design proactive PMCF studies, such as registries, observational studies, patient-reported outcomes, and clinician surveys. These activities must be justified based on device classification, innovation level, and known clinical risks. Importantly, the outcomes must be statistically analyzed and directly feed into the CER to demonstrate performance under normal conditions of use. Strengthening the loop means ensuring that every PMCF activity has a traceable output that informs clinical decision-making and supports regulatory documentation.

Utilizing PMS Data for Clinical Risk Updates

To enhance the feedback loop, PMS data—including incident reports, Field Safety Corrective Actions (FSCAs), and vigilance findings—must be systematically analyzed to detect new risks or shifts in benefit-risk balance. These findings should not only trigger updates in the risk management file (RMF) but must also be reflected in the CER’s conclusions. Establishing a strong internal process to link risk signals from PMS directly to the clinical evaluation ensures compliance with MDR Article 83 and Annex III. Additionally, unexpected trends in PMS outcomes may necessitate additional PMCF activities, thereby reinforcing the iterative nature of clinical evaluation.

Leveraging Digital Systems for Data Integration and Traceability

A robust PMCF and PMS feedback loop requires seamless data integration, which can be facilitated by modern digital tools and quality management systems. Cloud-based platforms allow real-time data collection, trend analysis, and automated traceability across technical documentation. Manufacturers can use dashboards to monitor adverse event rates, PMCF completion status, and CER revision needs. These systems help ensure that clinical evaluation is not static, but a living process informed by reliable, traceable, and timely feedback. This level of integration is essential for meeting the stringent expectations of Notified Bodies under the MDR framework.

Ensuring Organizational Alignment and Regulatory Readiness

Finally, strengthening the PMCF and PMS feedback loop requires cross-functional collaboration within the organization. Regulatory, clinical, quality, and post-market teams must work together to ensure data flows efficiently and is interpreted consistently. Regular internal audits and readiness checks can help ensure that all relevant data is being captured, analyzed, and fed into the CER appropriately. By embedding these practices into the organization’s quality management system, manufacturers not only improve compliance but also increase their readiness for audits and inspections by Notified Bodies.

Use tools and platforms to collect post-market data (registries, surveys, observational studies).
Feed back into CER with clear summaries and impact assessments.

4. Prepare and Maintain an Equivalence Justification File

Definition and Purpose of Equivalence Justification

An Equivalence Justification File is a structured, evidence-backed document created to demonstrate that a manufacturer’s device is equivalent to another device already supported by clinical data. Under the EU MDR (Regulation 2017/745), using clinical data from an equivalent device is allowed only if the manufacturer can prove equivalence across technical, biological, and clinical characteristics. The primary purpose of the file is to reduce the burden of conducting new clinical investigations by leveraging existing data—while meeting the much stricter MDR standards for evidence, transparency, and traceability.

Core Criteria for Demonstrating Equivalence

EU MDR requires that all three dimensions of equivalence—technical, biological, and clinical—must be demonstrated in parallel. Technically, the devices must have the same design, specifications, performance, and principles of operation. Biologically, materials that interact with the patient’s body (especially implantables or long-term contact devices) must be identical in composition and tissue interaction. Clinically, the devices must have the same intended purpose, indications, patient populations, and conditions of use. These equivalence claims must be supported with strong documentation such as engineering drawings, material specifications, and published clinical studies.

Documentation Requirements

The Equivalence Justification File must include a side-by-side comparison table between the manufacturer’s device and the claimed equivalent device. Each dimension (technical, biological, clinical) should be addressed separately and supported by credible data sources. For technical characteristics, manufacturers often include device schematics, performance test results, and specification sheets. Biological equivalence requires biocompatibility data, material certifications, and ISO 10993 test reports. Clinical characteristics are demonstrated through comparative indications for use, labeling, instructions for use (IFUs), and clinical outcomes from peer-reviewed literature.

Access to Data of Equivalent Device

One of the most critical MDR requirements is that manufacturers must demonstrate they have full access to the technical documentation of the equivalent device—particularly when the equivalent device is not their own product. This includes access to design files, clinical data, manufacturing processes, and post-market information. Without full access, NBs will likely reject the equivalence claim. In cases where equivalence is claimed to another manufacturer’s product, the file must include either a formal agreement granting data access or a justification for using only publicly available data (which is rarely sufficient).

Common Pitfalls and NB Rejections

Equivalence Justification Files are often rejected by Notified Bodies when they rely on outdated, incomplete, or poorly sourced data. A common mistake is citing similarity in design or intended use without addressing differences in materials or clinical outcomes. Additionally, referencing literature that describes the equivalent device without providing access to its full technical documentation typically results in non-acceptance. Another issue is using broad or vague terms like “similar in function” or “same principle” without quantifiable comparisons and proper context.

Best Practices for Maintaining the File

To meet MDR expectations, the Equivalence Justification File should be maintained as a living document and updated regularly, especially when there are changes in clinical practice, materials, or manufacturing processes. Manufacturers should perform gap assessments to ensure continued alignment with the equivalent device, and incorporate feedback from post-market surveillance (PMS) and post-market clinical follow-up (PMCF) activities. Integration with other regulatory documents such as the Clinical Evaluation Report (CER), Risk Management File, and IFU is essential for consistency and regulatory compliance. Clear version control, audit trails, and documentation of rationales for every equivalence claim are also strongly recommended.

Include side-by-side tabular comparison (technical, biological, clinical).
Reference product datasheets, specs, material composition, etc.
Include letters of access (if available).

5. Align CER with Risk Management and SSCP

Aligning CER with Risk Management Documentation

A crucial requirement under EU MDR is the alignment of the Clinical Evaluation Report (CER) with the device’s risk management documentation, particularly the Risk Management File (RMF) as per ISO 14971. The CER must clearly reference and support the identified hazards, risk control measures, and residual risks documented in the RMF. This means that any clinical risks or adverse events discussed in the CER must correspond to those identified during risk analysis. Furthermore, the clinical data presented—whether from trials, literature, or post-market sources—should directly validate the effectiveness of the implemented risk control measures. For instance, if a risk control strategy includes design changes to reduce infection, the CER must provide clinical data showing a corresponding decrease in infection rates. Any discrepancies between the CER and the RMF can trigger questions or non-conformities during a Notified Body review. Therefore, regular collaboration between clinical, regulatory, and quality assurance teams is essential to ensure mutual consistency and traceability across both documents.

Aligning CER with SSCP (Summary of Safety and Clinical Performance)

For Class III and implantable devices, the Summary of Safety and Clinical Performance (SSCP) is a publicly available document required under MDR Article 32, and it must be directly aligned with the information presented in the CER. The SSCP is meant for healthcare professionals and, in certain cases, patients, and serves as a high-level summary of the device’s clinical evidence, safety, and performance outcomes. The CER, which contains in-depth data, acts as the source document for many of the SSCP’s sections. Therefore, discrepancies—such as differences in clinical indications, adverse event rates, or benefit-risk conclusions—between the CER and SSCP can lead to regulatory flags. The SSCP must also reflect current post-market data, and any updates to the CER following PMCF or PMS activities should trigger a corresponding SSCP revision. Maintaining alignment ensures both regulatory compliance and public trust, and also aids healthcare professionals in making informed decisions. Manufacturers should establish a formal review process to ensure CER updates are consistently reflected in SSCP content.

CER must support risk-benefit conclusions from ISO 14971 process.
Keep all risk, IFU, SSCP aligned with CER findings.

Tools & Resources Used by Top Manufacturers

Systematic Literature Review Tools

Top manufacturers rely on specialized tools like DistillerSR, Covidence, and Rayyan to perform structured and reproducible systematic literature reviews (SLRs) as required by MEDDEV 2.7/1 rev. 4 and MDR Annex XIV. These platforms allow teams to manage large volumes of scientific literature efficiently, enabling filtering, tagging, duplicate removal, and transparent documentation of inclusion/exclusion criteria. Features like PRISMA diagram generation and audit trail tracking help streamline the process and ensure regulatory scrutiny readiness. These tools are critical for sourcing high-quality clinical data and presenting it transparently in the CER.

Quality Management System (QMS) Platforms

To manage CERs in alignment with other MDR technical documentation, manufacturers often use integrated QMS platforms like Greenlight Guru, MasterControl, Veeva Vault QMS, and Qualio. These platforms offer document version control, electronic signatures, audit trails, and regulatory workflows. They support CER development by embedding it into a structured QMS, ensuring alignment with risk management, post-market surveillance (PMS), and design documentation. Built-in compliance templates, SOP enforcement, and access controls make them particularly valuable for both large enterprises and SMEs facing MDR audits.

Post-Market Surveillance (PMS) and PMCF Data Collection Tools

Collecting and analyzing real-world clinical data is essential for meeting MDR’s post-market requirements, and manufacturers often use platforms like Climedo Health, Smart-Trial, Medrio, and Castor EDC to facilitate this. These tools help design digital surveys, patient-reported outcome measures (PROMs), clinician feedback systems, and observational studies tailored to each device. They enable the real-time capture of PMS and PMCF data across regions, ensuring timely integration into CERs and improved risk-benefit assessment. These platforms also provide built-in analytics and dashboards, simplifying PMCF reporting and enhancing traceability.

Clinical and Regulatory Writing Services

Many manufacturers partner with experienced medical writers, clinical research organizations (CROs), or regulatory consultants to ensure their CERs are written to MDR expectations. These experts bring knowledge of MDR Article 61, Annex XIV, ISO 14155 (for clinical investigations), and MDCG guidance documents. They assist in constructing well-structured CERs with properly referenced literature, risk-benefit analyses, and statistical data interpretation. Services from firms like RQM+, Avania, Veranex, and Maetrics help bridge internal resource gaps, especially for SMEs or niche device manufacturers.

Clinical Evaluation Templates and Regulatory Guidance

To standardize submissions and align with Notified Body expectations, manufacturers use templates and guidelines published by regulatory authorities. MDCG 2020-13 offers a structured Clinical Evaluation Assessment Report (CEAR) template, which Notified Bodies use to evaluate CERs. Following this template helps ensure that all critical elements—such as clinical evidence appraisal, equivalence justification, and PMCF integration—are addressed in a format that NBs are familiar with. Additionally, continued reference to MEDDEV 2.7/1 rev. 4 remains standard practice, as it provides foundational guidance for the CER lifecycle and literature review methodologies.

Tool/Platform	Purpose
DistillerSR / Covidence	Systematic literature review
QMS tools (MasterControl, Greenlight Guru)	CER process management
PMS/PMCF platforms (Climedo, Smart-Trial)	Real-world evidence collection
Medical writers or CROs	Outsourced CER preparation
Clinical evaluation templates (MDCG 2020-13)	Standardized NB-accepted format

Comparison: Poor vs Strong CER

Clinical Evidence Quality

A poor CER often relies on outdated, generalized, or non-device-specific clinical data, sometimes sourced from unrelated literature or assumed equivalence. This approach fails to demonstrate the actual performance or safety of the device in question, leaving significant gaps in evidence. In contrast, a strong CER presents up-to-date, device-specific clinical data—preferably including clinical investigations, published studies, or real-world evidence such as registry or PMS data. The data is thoroughly analyzed and clearly linked to intended use, performance claims, and safety endpoints, offering robust support for conformity under Article 61 and Annex XIV of MDR.

Systematic Literature Review Methodology

In a weak CER, literature searches may be unsystematic, lack reproducibility, or omit key details such as search terms, databases used, inclusion/exclusion criteria, or date limits. This compromises the scientific rigor and traceability of the clinical evaluation. By contrast, a strong CER includes a clearly documented, repeatable Systematic Literature Review (SLR) conducted using predefined protocols. It includes a comprehensive methodology based on PRISMA standards or similar, and presents a flow diagram detailing article selection, risk of bias assessment, and a structured summary of findings that directly support the clinical evaluation.

Post-Market Surveillance and PMCF Integration

Poor CERs often treat post-market surveillance and Post-Market Clinical Follow-up (PMCF) as separate or generic processes, merely referencing PMS reports without truly integrating the data into the evaluation of clinical performance and safety. In contrast, a strong CER actively incorporates current PMS and PMCF data to confirm the device continues to meet safety and performance expectations. This includes trending of complaint data, vigilance events, adverse incident rates, and PMCF study outcomes, with a discussion on how these results affirm or update the clinical benefit-risk profile.

Equivalence Justification

A weak CER may reference another marketed device for equivalence without providing detailed or documented justification, often lacking access to confidential technical data. This approach no longer satisfies MDR requirements, particularly for implantable or Class III devices. A strong CER, on the other hand, thoroughly justifies equivalence through a side-by-side comparison of technical, biological, and clinical characteristics. It includes tangible evidence, such as device schematics, material specifications, and clinical data, and explicitly states that the manufacturer has full access to relevant data from the equivalent device to substantiate their claims.

Alignment with Risk Management and Other Documentation

Poor CERs are often misaligned with the device’s risk management documentation, Instructions for Use (IFU), or Summary of Safety and Clinical Performance (SSCP), leading to discrepancies that raise red flags during Notified Body review. Strong CERs ensure consistency across all technical documentation. Risk management outcomes, including identified hazards and risk control measures, are clearly referenced and reflected in the clinical evaluation. Furthermore, performance objectives in the CER align with those stated in the IFU and are supported by evidence and data within the CER.

Currency and Lifecycle Maintenance

Weak CERs tend to be static documents that are rarely updated unless a major incident occurs, failing to reflect ongoing device use and safety in real-world settings. This outdated information undermines the credibility and relevance of the clinical evaluation. In contrast, a strong CER is treated as a living document, updated periodically in accordance with the PMS/PMCF findings or following any significant changes to the device, labeling, or clinical environment. This dynamic approach ensures the CER remains compliant with MDR’s lifecycle-based clinical evaluation model and supports continuous CE marking validity.

Parameter	Weak CER	Strong CER
Clinical Evidence	Generalized or historical	Device-specific, up-to-date
Literature Review	Unstructured	SLR with clear protocol
PMCF Integration	Minimal or generic	Specific data with measurable outcomes
Equivalence	Poorly justified	Justified with full access and documentation
Updates	Static	Living document, updated yearly or after major changes

Final Recommendations

Adopt a Proactive, Lifecycle-Based CER Strategy

Manufacturers should shift from a reactive, one-time documentation model to a proactive, lifecycle-based clinical evaluation approach. This means treating the CER not as a static regulatory artifact prepared only for certification but as a dynamic, living document that evolves with the device throughout its time on the market. The EU MDR mandates that clinical evaluations be updated regularly, especially when new safety data, changes in the device, or findings from post-market surveillance (PMS) or post-market clinical follow-up (PMCF) arise. Proactively maintaining the CER helps ensure readiness for audits and reduces the risk of certification delays or withdrawals due to insufficient clinical data.

Build a Skilled Clinical Evaluation Team

Creating CERs that withstand Notified Body scrutiny requires a multidisciplinary team with expertise in clinical writing, regulatory affairs, biostatistics, and the specific therapeutic area of the device. The team should be well-versed in the EU MDR requirements, especially Annex XIV Part A, MEDDEV 2.7/1 Rev. 4, and the latest guidance from MDCG (Medical Device Coordination Group). Trained personnel can effectively interpret clinical data, apply systematic literature review methodologies, assess equivalence justifications, and align CER conclusions with risk management outputs. Investing in internal training or engaging experienced external consultants or clinical research organizations (CROs) can ensure a high standard of CER preparation.

Engage Early with Notified Bodies

Manufacturers should seek early dialogue with Notified Bodies, particularly when dealing with high-risk devices or complex equivalence arguments. Engaging in pre-submission consultations or clarification meetings can help align expectations before the formal submission. This collaboration can provide insight into how the Notified Body interprets current regulatory guidance, reducing the likelihood of major non-conformities during the conformity assessment process. Proactive communication also allows manufacturers to clarify uncertainties around clinical evidence requirements or device classification issues.

Establish Strong Post-Market Evidence Collection Mechanisms

One of the most significant changes under the MDR is the emphasis on integrating real-world clinical data into the CER through PMCF and PMS activities. Manufacturers should deploy structured mechanisms—such as observational studies, registry data collection, and patient feedback tools—to gather relevant post-market data. Using digital platforms for data capture and analysis can streamline the PMCF process. These findings must be clearly summarized and critically analyzed in the CER to demonstrate that the device continues to perform safely and effectively in actual use settings. Timely and comprehensive integration of PMCF findings enhances the credibility of the CER and reduces regulatory risk.

Maintain Consistency Across Technical Documentation

Consistency is critical when submitting documentation to a Notified Body. The conclusions and data presented in the CER must be aligned with other components of the technical file, such as the risk management file (per ISO 14971), Instructions for Use (IFU), and the Summary of Safety and Clinical Performance (SSCP). Any discrepancies among these documents can lead to non-conformities and delays in certification. A robust internal review process should ensure that risk-benefit analyses, clinical claims, and safety concerns are harmonized across all relevant documentation. When updates are made to one document due to new findings or post-market events, corresponding updates must also be made to the CER.

Implement a Continuous CER Maintenance System

To comply with MDR’s emphasis on lifecycle oversight, manufacturers must establish a structured process to periodically review and update the CER. This includes monitoring for newly published literature, changes in clinical practice, competitor developments, and evolving regulatory expectations. A well-defined update schedule—at minimum, annually for higher-risk devices or more frequently in response to new data—ensures that the CER remains current and defensible during audits or surveillance assessments. Utilizing version control, update logs, and audit trails can help document these changes in a traceable manner, further supporting regulatory compliance and operational efficiency.

Adopt a proactive, lifecycle-based CER strategy, not a reactive approach.
Ensure clinical writing teams are trained on MDR, ISO 14155, MEDDEV 2.7/1 rev. 4.
Engage with Notified Bodies early (e.g., via Q-Sub meetings) to align expectations.
Keep a living CER that is periodically updated with real-world clinical and safety data.