Sophie Laurenson, MDR consultant on Kolabtree, shares 5 tips for writing a clinical evaluation report and defining a CER strategy.
The EU MDR has significantly impacted the way medical devices are regulated in Europe. As part of regulatory compliance, medical device manufacturers need to create and maintain a Clinical Evaluation Report (CER), a document essential for CE Marking. Here are expert tips on what to take into account to defining a robust CER strategy.
1. Define a CER protocol and strategy
Identify the Essential Requirements (Safety and Performance Requirements in the MDR) that need to be supported by clinical evidence. Define metrics relative to performance, safety and risk/benefit endpoints.
2. Demonstrate equivalence
Equivalence is determined based on the comparison between a medical device and other pre-existing, similar CE-marked devices. The demonstration of equivalence is evaluated on relevant parameters that are defined by the manufacturer. The rationale for equivalence must be fully explained in the CER. The criteria for equivalence have become complex and stringent, with stronger connections to the Essential Requirements. It is critical to avoid the common mistake of selecting equivalent devices that are not relevant to your product. Documented data must be identified and analyzed for each equivalent device and for the differences between devices.
3. Evaluate literature review data
If equivalency can be demonstrated adequately, clinical data extracted from literature on previous studies is a valuable tool in compiling a CER. However, it is critical that literature surveys are conducted in a systematic process:
• Prepare a comprehensive protocol for the literature review,
• Define inputs and parameters such as databases, search terms and exclusion criteria (languages, study type / design, study setting, endpoints),
• Define the required safety and performance criteria based on the equivalent products and risk analysis,
• Systematically gather relevant articles from different data sources,
• Analyze the data using an objective method such as a framework and using multiple reviewers, and,
• Document conclusions of the literature evaluation for inclusion in the CER document.
4. Determine requirement for clinical investigation
The requirement for a clinical investigation is determined by the risk profile of the device. High risk and Class III devices must be subject to a clinical investigation. Novelty is also a determining factor, and devices based on innovative technologies or for a new intended use with require clinical investigation. The available clinical evidence must address all the pertinent ERs. This can be ensured by sharing the Clinical Investigational Plan (CIP) with the relevant NB prior to implementation.
5. Monitor post-market activities
Under the MDR, PMS activities must be adequately planned and documented in the CER. The processes for evaluating ongoing clinical data and updating CERs must also be documented. To ensure that the CER remains relevant throughout the product lifecycle, it must be updated regularly through a documented process. This includes evaluating the data and weighing the relevance of all equivalent devices.
Need help with writing a clinical evaluation report? Hire a freelance Medical Device CER writer on Kolabtree. It’s free to post your project and get quotes.