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Under the EU MDR 2017/745, a CER is not just a snapshot of clinical evidence—it is a structured, living demonstration that the device remains safe, performs as intended, and delivers a favorable benefit–risk profile throughout its lifecycle. After finalizing the device description, manufacturers must elevate the CER with rigorous data stratification, a clear link to GSPR compliance, a defensible benefit–risk assessment, and a plan for continuous updates embedded into the QMS.
1. Stratification of Data and Analysis
Once the device description is finalized, the stratification of data becomes essential to demonstrate that all device characteristics and intended uses have been methodically evaluated. This process involves organizing clinical evidence based on specific factors relevant to the device, such as:
- Device variants and models with significant differences in design or materials.
- Specific indications and sub-indications, as data from one cannot always be extrapolated to another without justification.
- Patient populations, including distinctions between adult and pediatric groups.
- Device lifetime and compatibility with other devices.
For devices with broad indications (like MRI or CT scanners), the volume of data can be overwhelming; here, manufacturers should focus on the most critical and common indications that represent the overall safety and performance profile.
Conversely, “orphan medical devices” intended for rare conditions (affecting no more than 12,000 individuals in the EU per year) require a different approach. While the quantity of data may be low, the analysis must be scientifically grounded, justifying the orphan designation based on a lack of alternatives or expected clinical benefits. In these cases, high-quality non-clinical data can help bridge gaps in pre-market clinical evidence, provided they are supported by a robust Post-Market Clinical Follow-up (PMCF) plan.
2. GSPR Compliance
Demonstrating compliance with the General Safety and Performance Requirements (GSPR) is a primary objective of the CER. This section should link directly to the GSPR checklist in the technical documentation, focusing particularly on GSPRs 1–8, at least.
Compliance is not just a checkbox exercise; it requires an analysis of clinical safety and performance to conclude that the device performs as intended under normal conditions of use. This assessment must show that:
• The device delivers the intended clinical benefit.
• The safety profile is acceptable, and any side effects are manageable.
• The findings support the overall benefit-risk assessment.
3. Benefit-Risk (B/R) Assessment
The Benefit-Risk assessment is mandatory for all devices and must be proportional to the device’s classification. Higher-risk devices typically require a more extensive evaluation of direct benefits versus potential risks.
Key elements of a robust B/R assessment include:
- Contextualizing data against the State of the Art (SOTA): The device must be compared to current technical capabilities and accepted clinical practices to determine if its risks are acceptable relative to its benefits.
- Magnitude and Duration: Evaluators must consider how long benefits last and the severity of risks over the entire lifetime of the device.
- Medical Expert Involvement: It is highly recommended that these assessments be reviewed by medical professionals (e.g., clinicians or nurses) who understand the real-world clinical context and patient management.
4. Updates and Other Considerations
The CER is not a static document; it is the output of a continuous clinical evaluation process that must be integrated into the manufacturer’s Quality Management System (QMS).
Evaluator Competence and Bias
Manufacturers must ensure that CER evaluators are suitably qualified and possess demonstrated experience with the specific device or patient population. To maintain objectivity, it is best practice to select evaluators who were not involved in the device’s clinical studies to avoid bias.
Future Perspectives (2025 Proposals)
The regulatory landscape is shifting toward greater efficiency. Proposed amendments to the MDR suggest several streamlined measures:
- Merged Reporting: Manufacturers may soon be able to include PMCF findings directly within the CER, eliminating the need for a separate PMCF evaluation report.
- Broader Data Acceptance: There is a move toward accepting non-clinical data (like in silico testing or computer modeling) when clinical data is not appropriate, as long as it is justified by risk management.
- Simplified Equivalence: For established devices, the requirement for a contractual agreement to access an equivalent device’s technical documentation may be removed, significantly lowering barriers for manufacturers.
By staying proactive with these updates and ensuring rigorous data stratification, manufacturers can build a convincing rationale for Notified Bodies and ensure the long-term success of their devices.
Conclusion
A mature CER shows more than “we have data”: it proves that evidence has been systematically organized across variants, indications, populations, and lifetime; that clinical conclusions directly support GSPR compliance; and that benefits remain justified against risks in the context of the State of the Art. By ensuring evaluator competence and independence, maintaining consistency across the Technical Documentation and IFU, and proactively integrating PMS/PMCF outputs and evolving regulatory expectations, manufacturers can build Notified Body confidence and sustain compliance over time.