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Under the EU Medical Device Regulation (MDR) 2017/745, the Clinical Evaluation Report (CER) is often described as the “beating heart of the Technical Documentation.” It is no longer enough to compile a summary of available information: Notified Bodies expect a structured, transparent, and evidence-driven demonstration that the device meets its intended purpose while remaining safe and performing as claimed. To support a smooth review and approval process, manufacturers shall: (1) clearly define and substantiate device claims, (2) reconduct producible literature and vigilance search strategies with a robust appraisal plan, and (3) where necessary, implement clinical investigations (or justified exemptions).
1) Defining and Substantiating Device Claims
Under MDR Article 7, device claims encompass all information regarding the device’s intended purpose, safety, performance, and benefits provided in labeling, instructions for use (IFU), and even advertising media or websites. These claims are central to the CER because the evaluation must be proportionate to the nature of the device and the specific claims made by the manufacturer.
Claims generally fall into two categories:
- Non-clinical claims: These are technical in nature and based on non-clinical data, such as standards compliance, technology use, sterility, or mechanical performance.
- Clinical claims: These relate to safety, performance, or clinical benefits—such as improved patient outcomes or reduced complication rates—and must be substantiated with appropriate clinical evidence.
For clinical claims, manufacturers must clearly define acceptance criteria. Systematically reviewing and categorizing these claims is a “good practice” that helps justify the chosen clinical evaluation route, particularly if a manufacturer intends to use Article 61(10) to rely solely on non-clinical data.
2. Literature Search, Vigilance Search, and Appraisal Plan
To win the trust of a Notified Body (NB), a manufacturer must implement a robust and transparent search protocol. This process should ideally involve at least two separate searches to ensure comprehensive coverage:
- State of the Art (SOTA) Search: This provides the clinical background, current knowledge, and alternative treatment options in the field, establishing a benchmark for assessing the device under evaluation.
- Device Under Evaluation (DUE) Search: This focuses specifically on the subject device (and equivalent devices, if applicable) to gather direct evidence of safety and performance.
Each strategy requires a clear justification of search terms, databases, and inclusion/exclusion criteria to ensure the methodology is reproducible and scientifically sound. Furthermore, the appraisal plan must be consistently applied to evaluate the suitability and contribution of the data. Even if a search yields no relevant data, a well-implemented protocol demonstrates a level of thoroughness that builds confidence in the overall report.
3. Documenting Clinical Investigation(s)
Clinical investigations are a mandatory requirement for all new Class III and implantable devices, unless specific exemptions apply. These exemptions include Well-Established Technologies (WET), successfully claimed equivalence, or modifications to devices already marketed by the same manufacturer. If a manufacturer chooses not to perform an investigation based on these exemptions, they must provide a clear justification within the CER per Article 61(7).
It is important to note that Class IIa and IIb non-implantable devices are not exempt if their safety and performance cannot be substantiated through other sufficient clinical evidence. When documenting investigations, the CER should source information from the Clinical Investigation Plan (CIP) and the latest Clinical Investigation Report (CIR).
Providing complete supporting documentation is essential for the Notified Body to verify that data was obtained legally and responsibly. If any required element is missing, the manufacturer must always provide a detailed explanation as to why it was not provided.
Conclusion
A strong CER is built on consistency, traceability, and scientific rigor. By systematically structuring device claims (and defining acceptance criteria), implementing transparent and reproducible search methodologies (SOTA and DUE) with consistent appraisal, and documenting clinical investigations—or thoroughly justifying why they are not performed—manufacturers can significantly reduce Notified Body questions, avoid evidence gaps, and demonstrate full control of their clinical evaluation strategy. Ultimately, this approach does more than support compliance: it builds confidence that the clinical evaluation is complete, reliable, and aligned with MDR expectations.