A Clinical Evaluation Report (CER) is used to document the conclusion of the clinical evaluation of your medical device. CER is prepared by MEDDEV 2.7.1 Rev 4 to demonstrate that the intended purpose of the medical device is served without subjecting patients to any additional risk. 

CER demonstrates the performance and safety of your medical device, either with the help of your device's clinical data or based on the literature and other studies associated with its equivalent device.

Why is the clinical evaluation report important?

To sell or distribute your medical device in Europe, you must obtain the CE marking for your medical device. To acquire CE marking, your medical device must be evaluated and a CER based on the evaluation must be prepared. 

It is required to send the CE Technical File together with its associated CER to obtain the CE Mark for your medical device from the Notified Body.

How can we help?

We are here to help you with CER preparation and literature reviews. We specialize in the evaluation of clinical data from medical devices and we make sure that your CER is fully compliant with European Clinical Evaluation Consultants requirements. Our expert team of regulatory experts will do an in-depth assessment for the CER. 

Here are the services we offer:

Evaluate the clinical data of your medical device.Collect and study appropriate scientific literature that applies to your medical device or its equivalent devicePrepare the CER by European (EU) requirementsPrepare procedures for CER compilationConduct clinical literature reviews for upcoming CER updatesIf necessary, we can create a protocol to search and evaluate journal items methodologically and provide a synopsis.

Our mission is to help all medical device manufacturers with a practical approach, translating existing regulations into understandable requirements, providing guidance to obtain and maintain official market access for their safe and qualitative medical devices without making regulation more complicated.