AI Clinical Evaluation Report Generator

A Clinical Evaluation Report (CER) is a comprehensive document that summarizes and appraises the clinical data relating to a medical device, demonstrating its safety, performance, and clinical benefit when used as intended. Under the EU Medical Device Regulation (EU) 2017/745 (EU MDR), clinical evaluation is a mandatory requirement for all medical device classifications, from Class I through Class III. Article 61 of the EU MDR explicitly states that manufacturers must conduct a clinical evaluation that shall be 'thorough and objective' and consider both favorable and unfavorable data.

The CER serves as the cornerstone of a device's clinical evidence strategy and is a required component of the technical documentation under Annex II of the EU MDR. Unlike the previous Medical Device Directive (MDD 93/42/EEC), where clinical evaluation requirements were less prescriptive, the EU MDR significantly raises expectations for the depth, rigor, and currency of clinical evidence. Notified Bodies now scrutinize CERs more intensively, with the Medical Device Coordination Group (MDCG) guidance document MDCG 2020-13 providing detailed expectations for clinical evaluation adequacy.

The CER must be updated at least annually for Class III and implantable devices, and at appropriate intervals (typically every 2–5 years) for lower-risk classes, as part of the Post-Market Clinical Follow-up (PMCF) cycle defined in Annex XIV, Part B. Failure to maintain an adequate CER can result in non-conformity findings during Notified Body audits, suspension of CE marking, and market withdrawal — consequences that have become increasingly common since the MDR transition deadline of May 26, 2024.

MEDDEV 2.7/1 Rev 4, published by the European Commission in September 2016, remains the primary guidance document for structuring Clinical Evaluation Reports, and its methodology is fully endorsed under the EU MDR framework. The document prescribes a staged approach consisting of five key stages: Stage 0 (Scope Definition), Stage 1 (Identification of Pertinent Data), Stage 2 (Appraisal of Pertinent Data), Stage 3 (Analysis of the Clinical Data), and Stage 4 (the Clinical Evaluation Report itself). Each stage feeds into the next, creating a traceable chain from data identification through to clinical conclusions.

The recommended CER structure includes: a device description and specification (including variants and accessories), an overview of the clinical evaluation scope and context, a description of the clinical background and current knowledge, the clinical evaluation plan reference, identification and selection of clinical data sources, summary and appraisal of clinical data (categorized as clinical investigations, literature, and clinical experience), analysis of safety data (including adverse events, complications, and side effects), analysis of performance data, benefit-risk determination, and conclusions. Appendices should include the literature search protocol, data appraisal worksheets, PMCF plan summary, and the list of referenced documents with full bibliographic citations.

Notified Bodies expect the CER to demonstrate a systematic, reproducible methodology. This means documenting the literature search strategy in sufficient detail that an independent reviewer could replicate it — including databases searched (PubMed, Embase, Cochrane Library at minimum), search strings used, date ranges, inclusion/exclusion criteria, and the number of articles at each screening stage (analogous to a PRISMA flow diagram). The CER should clearly distinguish between data generated by the manufacturer and independent data, and it must address any data gaps with a justified rationale for why remaining uncertainties are acceptable given the device's risk profile.

The EU MDR and MEDDEV 2.7/1 Rev 4 recognize three primary categories of clinical data for inclusion in a CER: data from clinical investigations of the device in question, data from the scientific literature relating to the device or an equivalent device, and data from clinical experience including post-market surveillance, vigilance reports, and PMCF studies. Article 2(48) of the EU MDR defines clinical data broadly as 'safety and/or performance information generated from the use of a device,' which encompasses both pre-market and post-market evidence.

For literature-based clinical data, the appraisal process must evaluate each source against defined quality criteria including methodological rigor (study design, sample size, statistical methods), relevance to the subject device (population, indication, clinical setting), and data integrity (completeness, potential for bias, conflict of interest). MEDDEV 2.7/1 Rev 4 provides specific appraisal criteria in its Appendix A9, rating data as 'pivotal,' 'supportive,' or to be 'excluded' based on these assessments. Each appraisal decision must be documented and justified — Notified Bodies routinely challenge CERs that exclude unfavorable data without adequate rationale.

Post-market data sources have become increasingly important under the EU MDR. PMCF data (Annex XIV, Part B), complaints, vigilance reports (Article 87–92), trend analyses, and registry data must all be integrated into the CER during updates. The MDCG 2020-7 guidance on PMCF evaluation reports clarifies how this data should flow into the clinical evaluation cycle. Manufacturers should also consider data from the EUDAMED database (when fully operational), national competent authority databases, and published field safety corrective actions. The weight of evidence from each data category should be assessed both individually and collectively to support a robust benefit-risk determination.

Equivalence assessment is one of the most scrutinized elements of a CER under the EU MDR. When a manufacturer relies on clinical data from an equivalent device rather than conducting its own clinical investigations, Article 61(5) requires demonstration of equivalence based on clinical, technical, and biological characteristics. All three dimensions must be satisfied simultaneously — partial equivalence is not acceptable. The clinical characteristics include the same clinical condition, same intended purpose, same site in the body, similar population, and similar relevant clinical performance. Technical characteristics encompass similar design, specifications, materials, surfaces, deployment methods, and principles of operation. Biological characteristics require the same materials in contact with the same human tissues or body fluids.

The EU MDR imposes a significantly higher bar for equivalence claims compared to the MDD. Article 61(5) further stipulates that manufacturers claiming equivalence must have a contract with the equivalent device manufacturer granting sufficient access to the technical documentation, clinical data, and ongoing performance data. This contractual requirement effectively eliminates equivalence claims against competitor devices, a practice that was common under the MDD. MDCG 2020-5 provides detailed guidance on clinical equivalence, emphasizing that differences between the subject device and the claimed equivalent must be identified and assessed for their impact on safety and clinical performance.

Manufacturers must present the equivalence assessment in a structured tabular format within the CER, comparing each clinical, technical, and biological characteristic side by side, documenting similarities and differences, and providing a justified conclusion on each parameter. Where differences exist, the CER must explain why these differences do not affect the clinical safety and performance conclusions. Notified Bodies frequently issue non-conformities for CERs with poorly substantiated equivalence claims, and MDCG 2020-13 specifically flags equivalence as a high-priority review area. For Class III and implantable devices, the EU MDR further restricts equivalence-based pathways under Article 61(4), generally requiring clinical investigations unless justified under narrow exceptions.

Post-Market Surveillance (PMS) data is integral to the clinical evaluation process under the EU MDR, creating a continuous feedback loop between market experience and the clinical evidence base. Article 83 requires manufacturers to establish, document, implement, maintain, and update a PMS system proportionate to the risk class of the device. The PMS data collected must be analyzed and fed into the clinical evaluation and risk management processes, with CER updates reflecting the cumulative real-world evidence on safety and performance.

Specific PMS data types that must be integrated into CER updates include: complaint data and trend analyses, serious incident reports submitted under the vigilance system (Articles 87–92), Field Safety Corrective Actions (FSCAs), PMCF study results (required under Annex XIV, Part B), data from registries and published literature updates, feedback from healthcare professionals and users, and analysis of state-of-the-art developments that may affect the device's benefit-risk profile. MDCG 2020-7 clarifies that the PMCF Evaluation Report should feed directly into the CER update cycle, and MDCG 2020-8 addresses how PMCF plans should be designed to generate clinically meaningful data.

For Class III and implantable devices, the CER must be updated at least annually per Article 61(11). For other device classes, the update frequency should be defined in the PMS plan and justified based on the device risk profile, with most Notified Bodies expecting updates every 2–3 years for Class IIa and IIb devices. Each CER update should clearly document what new PMS data has been incorporated since the previous version, how this data affects the benefit-risk determination, and whether any changes to the intended purpose, risk management, or instructions for use are warranted. A failure to integrate PMS findings into the CER is one of the most common non-conformity findings during Notified Body technical documentation reviews.

The benefit-risk analysis is the culminating assessment within the CER and must demonstrate that the residual risks associated with the device are acceptable when weighed against the clinical benefits for the intended patient population. Article 61(1) of the EU MDR states that clinical evaluation must demonstrate conformity with the General Safety and Performance Requirements (GSPR) in Annex I, which includes the requirement under Section 1 that devices shall be 'safe and effective' and that any residual risk is 'acceptable when weighed against the benefits to the patient.' The benefit-risk analysis must be conducted in accordance with EN ISO 14971:2019 (risk management for medical devices) and should align with the device's risk management file.

The analysis should systematically identify and quantify (where possible) the clinical benefits of the device, including direct therapeutic benefits, diagnostic accuracy improvements, patient quality of life impacts, procedural advantages, and health economic benefits. These must be substantiated by the clinical data appraised in earlier CER sections. Similarly, the risk side must catalog all identified risks — derived from preclinical testing, clinical investigations, literature reports, PMS data, and state-of-the-art analysis — with their estimated probability and severity. The analysis should compare the device's benefit-risk profile against available alternative treatments and the option of no treatment, as required by MEDDEV 2.7/1 Rev 4, Stage 3.

Notified Bodies expect the benefit-risk analysis to be more than a qualitative narrative. Where clinical data permits, quantitative or semi-quantitative methods should be employed, including complication rates, device survival analyses, number-needed-to-treat calculations, and comparative effectiveness metrics. The conclusion must be unambiguous: the clinical evidence demonstrates that the benefits outweigh the residual risks for each intended indication and patient population, or it does not. Any unresolved uncertainties must be addressed through defined PMCF activities in the PMCF plan. MDCG 2020-6 provides guidance on sufficient clinical evidence for legacy devices, emphasizing that the benefit-risk determination must account for the current state of the art, not historical benchmarks.

The EU MDR establishes both scheduled and event-driven requirements for CER updates. Article 61(11) mandates that the clinical evaluation and its documentation 'shall be updated throughout the life cycle of the device concerned' with specific frequency requirements based on device classification. Class III and implantable devices require at least annual CER updates, while Class IIa and IIb devices should follow the update schedule defined in the clinical evaluation plan, typically every 2–5 years depending on the risk profile and rate of technological change. Class I devices with clinical claims also require periodic updates, though less frequently.

Unscheduled CER revisions are triggered by several events: receipt of new safety or performance data that materially affects the benefit-risk determination, identification of previously unknown risks through PMS or vigilance activities, publication of significant new clinical evidence (such as a large-scale comparative study or meta-analysis), changes to the state of the art that alter the acceptable risk threshold, modifications to the device design or intended purpose that affect clinical performance, issuance of new or revised harmonized standards or common specifications, regulatory authority requests or Notified Body non-conformity findings, and results from PMCF studies that contradict previously held assumptions.

From a practical standpoint, manufacturers should implement a continuous monitoring process — often called a 'clinical evidence surveillance' or 'literature watch' system — that systematically scans for new relevant clinical data on at least a quarterly basis. This monitoring should cover medical literature databases, vigilance databases (MAUDE, BfArM, MHRA), standards updates, and competitor device safety communications. The PMCF evaluation report (per MDCG 2020-7) should document this ongoing monitoring and feed its conclusions into the CER update decision. Maintaining a version-controlled CER with a clear change log demonstrating when updates occurred and what data was incorporated is essential for demonstrating compliance during Notified Body audits.