Everything You Need to Know About Clinical Evaluation Reports
Several medical advancements are being made all across the globe today. It means that there are various medical devices involved too. When you have a medical device, there needs to a clinical evaluation report accompanying it.
This is documentation of conclusions evaluating your medical device. It consists of several things, but the essential core of it is all about data. The C.E.R. ensures that the device achieves the purpose that it was set aside for with minimal risks.
So, what more do you need to know about a clinical evaluation report?
What’s a C.E.R?
As stated above, a clinical evaluation report is a clinical evaluation of medical devices. The preliminary clinical evaluation report is data analysis. This is from data collected from the results of the study and clinical investigations on subsequent medical devices.
Purpose of a Clinical Evaluation Report
There are a few things that a clinical evaluation report seeks to address. And the core function of it is to find out if the medical device has achieved its intended purpose. The purpose needs to be achieved without putting anyone at risk – both the patients and users.
There are countries where a C.R.E. is mandatory on all medical devices. Most of the nations in Europe have this as a standard. The countries require that all medical devices used to submit a C.E.R. to a notified body.
The attachment should be submitted to the European C.E. Technical File. It is the only CE Marking that your device can obtain. This is the mark that you require to either distribute or sell the medical device. The team behind CiteMedical noted that certain establishments can help you prepare and file a C.E.R. You can also learn how to prepare a Clinical Evaluation Report below.
How to Prepare A C.E.R
Preparing a Clinical Evaluation Report takes place in three steps – if one is missed, it won’t get the mark. Here are the three steps to take:
- Identify clinical data – this can be obtained from clinical experience, trials, and literature. It can be in any combination of any of the three.
- Apprise date relevance – applicability, significance, quality. You don’t want data that has no specific value to the evaluation.
- Conclusion – you now need to relay your findings in the C.E.R. articulately, and it should be based on the collected data.
When it comes to writing the C.E.R., it becomes a little bit detailed, and below is how to do it.
How to Write a C.E.R
Define a protocol and strategy
You need to first define the relative metrics in terms of performance, risk, and safety. The essential requirements should identify it.
Demonstrate equivalence
This where you determine, in comparison, a difference between other existing marked devices and a medical device. The parameter used should be relevant to the ones defined by the manufacturer.
Evaluate literature review data
One of the basics that will go to the C.E.R. is literature data. This data has to be relevant to the report. Evaluating the data should keep you in good standing. When it comes to reviewing the data, it should be done in a systematic process, below is how:
- Prepare protocol for review
- Define input
- Determine the required safety criteria based on the product
- Gather relevant articles from different sources
- Data to be analyzed through objective methods
- Conclusion of literature evaluation
Determine requirement
Not all devices should be subject to constant clinical evaluation. You need to figure out the risk devices. The new devices that are intended for further use should be subject to C.E.R.
Monitor
You finally need to monitor the post-market activities. This means you need to have the whole report relevant by regular updates in a documented process.
Updates
There need to be regular C.E.R. updates as the central part of the post-market monitoring. All the changes that may occur during these times should be documented appropriately. This should be data that coincides with the initial data.
When you don’t regularly update, you won’t meet the requirements of C.E.R. In European countries where it’s mandatory, it could jeopardize your stand with the Medical Device Directive.
Quality should be paramount when it comes to medical devices, and that’s why the C.E.R. is there. When you don’t perform regular clinical evaluation reports on your medical devices, their risk factor goes up. An excellent clinical evaluation report consists of the above steps. You can find out there is to know about C.E.R. and how to write them as well above.
