11 Feb The New World of CER/CRBA Review
Recent experience has suggested that notified bodies are becoming more critical in their review of clinical evaluation reports (CER) or clinical risk/benefit analyses (CRBA). The format “suggested” in MEDDEV 2.7.1 r3 is now the expected. What does that mean to you? It means that the simple discussion of what is in each article is no longer sufficient, particularly if you are trying to avoid extensive clinical studies.
There are 3 critical components that must be included.
- The literature review
- The risk management strategy
- Any clinical data that you may have for your device
It is important to recognize that this is not a quick process. It can take 150-200 hours over several months to do it right, depending on the complexity of the device and the risk profile. Taking the time up front can save you time in the long run by avoiding non-conformities and having to re-write sections and effort to answer questions that were not addressed.
So how do you approach this?
Central to the process is a skilled medical writer with knowledge and experience related to the disease state and product as well as project management skills in order to bring all of the components together. Secondarily, standard processes, work instructions and checklists can be key to make sure that all of the necessary information is provided or accessible to the writer for inclusion in the report. The final step in this approach is to establish and maintain an open and communication collaborative process with the manufacturer.
What is included?
The Literature Review
It is important to understand the search terms for the literature review. It should not be just about “how many” but also what are the critical issues that need to be addressed to review the pertinent literature for both effectiveness, performance and safety. These should be summarized in table form and the quality of the references and their relevance noted. Summary data reflecting the overall findings should be described clearly in the text. This may require statistical support if the data are complex. Validation of the data and its description in the text should be part of this process.
The device should be clearly described, both in terms of its manufacturing (including references to technical documents as necessary) and intended use. Reviewers do not always have knowledge in the specific field and therefore it is important that the CER provide sufficient background and information so that it stands alone for the reviewer to understand the clinical context. More information is better than less and assuming that the reviewer knows little or nothing about your device and the medical condition is better than assuming they know a lot.
The review must also include a description of how you approach risk and risk mitigation. What you propose as thresholds for concern and how you got to those numbers is important. This will increase reviewer confidence that you will identify and address relevant risks to patients who may receive treatment or interact with your device.
Finally, but not to be minimized, it is necessary to detail the available clinical information with your device. Animal testing as part of the development process should be described but also what experience there has been with patients and under what circumstances. If there is experience with a previous version of the device it should be described how this new product is better, both for performance and safety, and how the previous clinical information applies to the newer product. How it compares to other marketed devices should also be included in this discussion.
The development of CERs/CRBAs is a far more detailed process than what has previously been acceptable. Partnering with an experienced group to assist in the process may be more effective than trying to do this internally. This approach allows you to focus on your core strengths including continued development, growth and sales while meeting the requirements for reporting. Boston Biomedical Associates is ready to help you develop and write your report, using our proven processes for generating CER/CRBA that meet MEDDEV requirements.