Medical devices often have to undergo several tests to get launched. A CER, short for Clinical Evaluation Report, documents such conclusions. It mainly includes the analyzed clinical data that it gets as either the results of other studies on similar devices or the clinical investigation of the device.
Its main motive is to prove that the medical device fulfils its purpose without exposing the patients and users to any additional risk. So naturally, all medical devices in Europe have to undergo this clinical evaluation.
Getting your device CE certified is an integral step required to distribute or sell your medical device in Europe. Once the CER is prepared, you will have to submit it to the respective Notified Body for evaluation.
How Should You Prepare For The CER?
The clinical evaluation mainly consists of three steps. First, the manufacturer collects clinical data from existing clinical experience, clinical trials, literature, etc. The second stage includes assessing the data’s applicability, relevance, significance, and quality. Lastly, you will have to articulate the conclusions in the report gathered from these data.
Even though you have to include the CER with your design dossier or technical file, it is best if you think of the CER as a standalone document. Some of the commonly added information in your CER includes:
- General Information: Manufacturer and device name.
- Technical and physical details of the device and its intended purpose.
- Report of diagnostic claims.
- All conducted clinical evaluations and data.
- The descriptive analysis evaluates the product literature’s safety, performance, and relevance.
- Summary of the review and clinical data.
- The conclusion is derived from performance, conformity, and security.
Although the details of any CER can change based on the device getting evaluated, its outcome should be the same. Therefore, the report should always be easily understandable by a Notified Body or any third party. Adding all the necessary information in explicit detail can help analyze, understand, and conclude the data.
Do You Have To Update Your CER?
Frequent updates are necessary for your CER as a part of vigilance activities and post-market surveillance. You should be able to document any evident changes that might affect the initial data. The CER must include all the latest data. If by any means you are not capable of doing so, you could jeopardize conformity with the Medical Devices Directive.
The most recent Medical Device Regulation in Europe will levy stricter measures for CERs. For example, it might include establishing uniformity with other similar devices and the quality of literature in the clinical evaluation.
This article shows all the additional benefits of preparing the CER document correctly; apart from getting certified that is. For example, suppose you plan to sell or distribute a new medical device; making a CER can help you better understand the prospects. In addition to that, it also helps in rectifying any issues that might later show up on your device.