Today we’ll cover some of the more critical aspects of clinical evaluation reports.
The clinical evaluation report, also known as a CER, is assessing and analyzing clinical data about a medical device. A clinical evidence report is needed for all classifications devices and consists of a combination of direct and indirect clinical data.
This is usually a combination of clinical trials, clinical investigations, published scientific papers, and post-market data from both publicly available sources and the manufacturer..
Our Clinical Evaluation report's primary purpose of a CER is to demonstrate a favorable risk-benefit profile of the medical device. It supports the clinical safety and efficacy of the medical device. It ultimately is used to demonstrate conformity with the relevant general safety and performance requirements in Europe and the central principles in Australia.
To provide a bit of additional context for this presentation, we wanted to give a bit of an overview of the jurisdiction or requirements and guidance with the clinical evidence reports.
In Europe, the needs and requirements for clinical evidence reports are dictated by the medical device regulations known as the MDR. This was due to come into effect in May of this year but has recently been delayed due to the pandemic and is now expected to affect May of 2021.
It is important to note that the MDR also has a requirement around a clinical evaluation report plan to be outlined and followed in addition to the clinical evaluation report.
The latest revision of the clinical evidence report guidance document known as the med dev 2.7/1 ref provides detailed direction on the format and the contact content of this clinical evidence report.
Well, there are some differences between Europe and Australia. They remain compatible, such that our manufacturers can produce a single clinical evaluation report to cover both Australian and European regulations.
In the US, while a formalized clinical evidence report is not defined within the USA FDA requirements, the data is still valuable in demonstrating that the device is safe and efficacious for its intended purpose, which is a requirement of the FDA regulations.
The content and purpose of the CER have relevance across all jurisdictions. A clinical evaluation report includes requirements for evaluation and then analyzed for both direct and indirect clinical data.
To know more about CER, Kindly visit our website https://www.i3cglobal.com/