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Under the European Union (EU) 2017/745 Medical Devices Regulation (MDR), the Clinical Evaluation Report (CER) has become more than just a summary—it is widely considered the “beating heart of the Technical Documentation”. Because the success of a device’s approval and commercialization depends heavily on the quality of this report, getting the foundational sections right is essential for a seamless review process
Defining the scope: Strategy Starts Early
Before a single piece of clinical data is analyzed, a manufacturer must establish exactly what is being assessed. Defining the scope at an early stage helps determine if the collected clinical evidence will ultimately cover the complete range of devices and configurations.
When setting your scope, you must address critical questions such as:
- Product Families: Can different product families be grouped within the same CER?
- Accessories and Instruments: Should accessories be evaluated here or in a separate report? For implants, are the associated instruments included in the clinical scope?
- Device Classification: For Class III devices, can multiple Basic UDI-DIs be combined into one report?
Clarifying these points prevents gaps in evidence that could lead to delays during Notified Body (NB) reviews
The Device Description: Accuracy and Consistency
The Device Description section provides the factual overview of the technology. The golden rule here is consistency: all details—including language and terminology—should be sourced directly from the Technical Documentation and Instructions for Use (IFU) without modification. This alignment is key to avoiding unnecessary questions from your Notified Body.
Under the MDR, this section must also address specific “special considerations”:
- • Device Novelty: You must declare if the device features a new design, intended purpose, or combination of features that have a clinical impact.
- • Device Lifetime: The CER must specify the period during which the device is safe and performs as intended. Crucially, this lifetime must be supported with clinical data within the report
Identifying Critical Characteristics
A robust CER requires a clear understanding of critical device characteristics, as these dictate what clinical data is needed to prove safety and performance.
- Multiple Indications: If a device is used for more than one indication, clinical evidence must support each one. Data from one use case cannot be automatically extrapolated to another without a solid clinical justification.
- Patient Populations: Safety and performance can vary between groups (e.g., adult vs. pediatric patients). Clinical data should represent each population or provide a scientific rationale for why extrapolation is valid.
- Size Ranges: Variations in size can affect mechanical performance or clinical outcomes. Evidence should ideally cover the extreme ends (smallest and largest sizes) or demonstrate that size differences do not introduce new risk.
- Materials and Design: Any significant differences in design, coatings, or materials may require a stratified analysis to ensure every variant is safe
Conclusion: Building Trust with Your Notified Body
A detailed and transparent Device Description does more than just list facts; it proves to the Notified Body that the manufacturer has done the necessary background work to design a thorough clinical evaluation plan. By including all crucial details and maintaining consistency across your documentation, you can prevent scrutiny and build trust in your clinical evaluation process