The Clinical Evaluation Report (CER) is a detailed summary of the evaluation information relevant to the clinical use of a medical device. All clinical data sources are considered, as well as some nonclinical trial data that may influence the benefit-risk analysis of the device. Taken together, the information contained in the CER provides a thorough understanding of the safety and performance of the device and provides the basis for determining if the device has an acceptable risk-benefit ratio received for its intended use or not.



The European Medical Device Registration (MDR) regulatory scenario is extremely dynamic, as are the regulations regarding CER. Therefore, to comply with these regulations and create compliant CERs, companies need to consult with regulatory experts.

CER and Mandatory Data Elements

General information about the medical device, such as the device's name and manufacturer

The device's physical and technical characteristics, as well as its application

A summary of the therapeutic and diagnostic claims

Data types and clinical applications

Clinical data review and summary

Analyses of the assessment processes are described.

Safety and efficacy conclusions

As part of aftermarket surveillance, the CER for medical devices must be updated regularly. Any changes that may affect equipment operation must be mentioned in the updated CER. Failure to do so may cause compliance issues. A CER must be updated every year. Whenever there is new information, potentially affecting an ongoing review, A CER is required. It is also required every 2 to 5 years if the equipment is well set up. For this purpose, a Clinical Evaluation Report Consultant is quite helpful.

Why Do You Need a 510k Consultant?
Section 510(k) of the Food, Drug, and Cosmetic Act requires device manufacturers to register to notify the FDA of their intent to market their medical device at least 90 days in advance. 510(k) is a pre-marketing submission submitted to the FDA to demonstrate that a commercially available device is safe and effective, which is essentially equivalent to a commercially available device. legal case (Section 513(i) (1)(A) FD&C Act).

FDA 510k consultants help you navigate the entire process for Class I, Class II, and Class III devices by fully understanding the device and identifying potential pitfalls. Qualified and experienced technical experts ensure faster 510k customs clearance. If you are looking for the best 510k consulting services, your search is over. Thomas Regulatory Resolutions can help you with all your needs with 510k.

EUA (Emergency Use Authorization)
The Emergency Use Authorization (EUA) authorizes FDA to help strengthen the nation's public health protections against chemical, biological, radioactive, and nuclear (CBRN) threats. including disease, facilitate the provision and use of medical countermeasures (MCMs) needed during a public health emergency.

We Are There For You
At Thomas Regulatory Resolutions, our FDA Emergency Use Authorization EUA Consultants can help you build the right strategy for bringing your product to market – and keep it there. The EUA has been both a disaster and a blessing for the medical device industry, providing a market-streamlining route for much-needed therapies, diagnostics, devices, and more. EUA requirements are frequently changing and sometimes flexible, opening the door for a range of questionable products to be developed in haste.