What Do You Understand By Clinical Evaluation Report?

Posted by Ethan Deower on May 24th, 2021

CER, also known as the clinical evaluation report, is a technical document that the medical device agencies want to distribute or sell. So, what is CER and what this offers? To know that, learning a detailed overview is quite essential.

The CER offers a comprehensive overview of the medical device design and composition. Along with that, CER also provides the utmost detailed overview of its usage, application, clinical trials analysis, relevant literature reviews, outcomes, protocols, and instructions for use.

Why Does this Clinical Evaluation Report Important?

The MDR mainly focuses on Clinical Evaluation Reports or CERs. CER forms part of a technical file that is considered as the primary documentation that demonstrates mandatory compliance. This offers all the essential details regarding the device. Medical device companies require taking several measures to ensure that their CER is well-prepared and well-maintained.

If you want to know the CER documentation, then you will have to ensure that this comprises four different stages:

• Defining the possibility of the device, its planned usage, and therapeutic/diagnostic claims
• Recognizing and validating clinical data
• Knowing and calculating the entire data and interpreting it to see if this can meet all the requirements
• Identifying risks and uncertainties that might be answered during post-market surveillance (PMS)

What is the Importance of Equivalence?

Medical device manufacturers should properly evaluate clinical data from their medical device or an equivalent device. Now, what is CER? To know what CER is, you also should know the importance of equivalence. Each medical device manufacturer should consider three major factors to prove the product is equivalent: clinical, biological, and technical.

Technical equivalence means that the device needs to have the exact design specifications and composition, and it has to be utilized in the same conditions. To get the details of equivalence, asking an expert from this field is very much important. Clinical equivalence means that this specific device should be utilized to treat the same condition at the same location in the body.

A professional or medical expert can clarify the thoughts regarding the clinical equivalence regarding MDR. You need to ensure that you get to know the complete details about it.

FAQ:

How Long Does It Take To Write A CER?

Recognizing and also gathering the data, which goes into CER, takes a few weeks or months.

Is CER a Static document?

No, this is not. This is a document for medical device manufacturers for developing the right strategy incorporating good practices to help them retain the market.

Is CER Important?

Yes, this is an essential document required by medical device companies