The CER also known as the clinical evaluation report, is a technical document that medical device agencies want to distribute or sell. So, what exactly is CER and what does it provide? To understand that, a thorough overview is required.
The CER provides a comprehensive overview of the design and composition of medical devices. CER also provides a comprehensive overview of its usage, application, clinical trials analysis, relevant literature reviews, outcomes, protocols, and usage instructions.
What is the significance of this Clinical Evaluation Report?
The MDR is primarily concerned with Clinical Evaluation Reports, or CERs. CER is a component of a technical file, which is regarded as the primary documentation demonstrating mandatory compliance. This provides all of the important information about the device. Several steps must be taken by medical device companies to ensure that their CER is well-prepared and well-maintained.
If you want to know about the CER documentation, you must first ensure that it is divided into four stages:
- Defining the device’s possibility, intended use, and therapeutic/diagnostic claims
- Recognizing and validating clinical data
- Understanding and calculating the entire data set and interpreting it to determine if it meets all requirements
- Recognizing risks and uncertainties that may be addressed during post-market surveillance (PMS)
What Is the Meaning of Equivalence?
Clinical data from their medical device or an equivalent device should be properly evaluated by medical device manufacturers. What exactly is CER? To understand what is CER, you must first understand the significance of equivalence. To prove the product’s equivalent, each medical device manufacturer should consider three major factors: clinical, biological, and technical.
Technical equivalence requires that the device have the same design specifications and composition and be used under the same conditions. To obtain the details of equivalence, it is critical to consult with an expert in this field. Clinical equivalence means that this device should be used to treat the same condition at the same site in the body.
A professional or medical expert can clarify your thoughts on clinical equivalence in MDR. You must ensure that you are well-versed in all aspects of it.
How Much Time Does It Take To Write A CER?
It takes a few weeks or months to recognize and collect the data that goes into CER.
Is CER a fixed document?
No, it isn’t. This is a document for medical device manufacturers to use in developing the best strategy for retaining market share.
Is CER Necessary?
Yes, this is a required document for medical device companies.