Clinical Evaluation Report
When to update medical device CER?
The manufacturer should update their CER based on ongoing clinical evaluations or on post-market surveillance plan.
- Every year CER required updates If the medical device is not expected to carry significant risks, then it should be updated every two to five years.
- When the manufacturer received new information from post-market surveillance that can also change the current evaluation.
Importance of a Clinical Evaluation Report (CER) for medical devices:
If you are planning to market your medical device in Europe, it is mandatory to have a CER that complies with MEDDEV 2.7.1 Revision 4 and the Medical Device Regulation (MDR)2017/745.
Before receiving CE marking in the European Union, medical device manufacturers must first prove that their devices meet the regulatory standards set out by the European Medical Device Regulation (MDR). The aim of the regulation is to ensure that patients are protected from unsafe products.
The aim of the Clinical Evaluation is to provide an independent opinion on the clinical safety and performance of the product. Clinical Evaluation refers to the process of evaluating the safety and effectiveness of a medical device before it can be placed on the market. The evaluation includes an analysis of the risks associated with the product as well as its benefits. This is done through a thorough review of the available scientific literature and clinical studies, which are then evaluated by independent experts.
Our team has developed an innovative way to write Clinical Evaluations using our proprietary technology. This technology allows us to streamline all the components of your CERs and Reports. With our solution, we can produce reports for devices you intend to submit for approval within the next few months.
Cert3Global can help with CER:
Cert3Global’s Clinical Evaluation Reports are written by experienced medical writers who have worked on many successful CE Mark applications. Our team will work closely with your company to ensure that your product complies with all relevant EU legislation and guidelines.
Contact us for more information!