Clinical Evaluation Report(CER) authoring
If you plan to sell your medical devices in Europe, you must produce and maintain a Clinical Evaluation Report (CER) that complies with MEDDEV 2.7.1 revision 4 and the MDD or MDR 2017/745. Your CER documents the result of the clinical evaluation of your device. Clinical evaluation involves the assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device.
Clinical evaluation reports are an important step in the path to CE Marking.
Clinical evaluation reports are an important step in the path to CE Marking.
A compliant CER should support strong clinical evidence that your device achieves its intended purpose without exposing users and patients to risk. The CER must be based on clinical data, which may include clinical data from existing literature, clinical experience, clinical trials, or any combination of the three.
We can assist with your EU Clinical Evaluation Reports and literature reviews. Titans specializes in reviewing medical device clinical data, and we can ensure your CER meets all European requirements. Our expert team of regulatory consultants brings depth of clinical experience with a range of medical devices and IVDs. We can:
- Gather and analyze appropriate scientific literature applicable to your device.
- Compile and draft the CER in compliance with EU requirements.
- Develop procedures to compile CERs and perform clinical literature reviews for future updates to your CER.
- If necessary, we can develop a protocol to methodologically search and evaluate journal articles and provide a synopsis.
