A Clinical Evaluation Report (CER) documents the clinical data of a medical device and allows the assessment of the safety and efficacy of the medical device’s performance. As such, a CER is vital to support design validation; and, importantly, approval to market. It includes the clinical data, analysis and appraisal of the data, and conclusions on the safety and efficacy of the device. It should summarise the intended use, residual risks and benefits and should be a stand-alone document.
The CER should be prepared taking into account the state-of-the art in the field, substantial equivalence to pre-existing devices in the market, and should be a proof of the claims made for the device. Because the CER is a live document, and not a single proof file submitted and forgotten, it should be updated with the risks associated with the use of the device, as manufacturers become aware of them at the post-market surveillance (PMS) stage.
As such, the first tip for a successful CER is: (1) it needs to be approached systematically, so that it takes less time to generate and forms a strong basis of the device’s safety and efficiency for future updates.
A CER can be written focussing on the literature route, on the clinical investigation route, or a combination of both. In the first case, the literature route focus on previously published data that support the device functions and equivalence with similar approved medical devices, from a technical, biological and performance point-of-view.
A second tip (2) is: use top research informatic solutions for retrieving medical device literature. Using a solution that performs automated searches and notifies the user of relevant new data saves considerable time; and, keeps the evaluator updated until the final stage of submission.
In relation to the clinical investigation route, it is based on clinical trial data that was conducted to evaluate the safety and performance of the medical device. The combination of both of these routes is where the winner finds itself. As such, here is the third tip (3) and what the manufacturers should look for when applying for approval: a combination of previously published reports, and novel clinical data that supports the safety and functionality of the medical device in question.
Several sections are important to take into account when creating a CER: state-of-the-art (SOTA), equivalence, risk-benefit analysis, and evaluator’s qualification.
In the SOTA section there should be a summary of the current knowledge in the field, standards and guidance; as well as, a brief summary of the clinical background and known hazards, benchmark devices, and medical alternatives.
In the equivalence section, clinical, biological and technical characteristics should be demonstrated when comparing medical devices; and, importantly, there should be no difference in terms of clinical safety and performance between devices for which the equivalence is being demonstrated. So, the fourth tip (4) is to make sure to choose the right device for comparison, not only in terms of materials but also proven clinical safety/performance.
In relation to the risk-benefit analysis section, the CER should discuss all risks associated with the device usage; and, examine the data to determine if the risk outweighs the benefit in terms of safety and performance. The clinical evaluation should be performed by a qualified individual who preferentially has expertise in the specific technology of the device and its applications. The evaluator should have a higher education degree coupled with a minimum of 5-10 years of documented professional experience, and any deviation from these credentials should be duly justified and documented in the CER. As such, the fifth tip (5) is: choose an evaluator with scientific expertise in the field of the medical device in question. Such person will have insider knowledge on the field, and create an easy-to-read document that can be easily updated in the future.
Since, as we said before, the CER is a live documented that should be updated throughout the product life-cycle, high-risk devices should be update on a yearly basis; while, low risk medical devices, can be update every 2-5 years. As such, choosing an evaluator that is available for future updates is an important asset to keep devices in the market and worries away.
Here is a summary of the tips to use:
1. CER systematic approach for easy future updates,
2. Top research informatic solutions for retrieving medical device literature,
3. Combination of previously published literature and novel clinical data,
4. Choose the right device for comparison based on proven clinical safety/performance,
5. Choose an evaluator with scientific expertise in the field of the medical device in question, and cherish this relation for quicker CER updates.