A Clinical Evaluation Report (CER) documents the conclusions of a clinical evaluation of your medical device. A CER consists of analyzed clinical data that was collected either from a clinical investigation of your device, or the results of other studies on substantially equivalent devices. The CER demonstrates that your device achieves its intended purpose without exposing users and patients to further risk.
Clinical Evaluation Reports are required for all medical devices in Europe. You must submit your CER to your Notified Body as an attachment to your European CE Technical File. The Technical File is an essential step to obtaining CE Marking for your device, which is required to sell or distribute medical devices in Europe.
How to prepare a Clinical Evaluation Report for medical devices
A clinical evaluation takes place in three steps. In step one, manufacturers identify clinical data from existing literature, clinical experience, clinical trials, or any combination of the three. Stage two involves appraising the data's relevance, applicability, quality, and significance. The third step requires you to articulate your conclusions in the CER, based on the data you collected.
Approach the CER as a standalone document even though you will include it with your technical file or design dossier. A list of possible elements to include in your CER is as follows:
- General information: device and manufacturer name
- Concise physical and technical device description and intended application
- Outline of intended therapeutic or diagnostic claims
- Clinical evaluation and data types
- Summary of clinical data and review
- Describe analyses used to assess performance, safety, and relevance/accuracy of product literature
- Conclusions about safety, performance, and conformity
Required updates to your Clinical Evaluation Report
Regular updates to your CER are required as part of your post-market surveillance and vigilance activities. You must record any notable changes that impact the initial data and append the CER accordingly. Failure to do so could jeopardize your conformity with the Medical Devices Directive.
Europe's new Medical Device Regulation (MDR) will impose even stricter requirements for Clinical Evaluation Reports, such as the basis of establishing equivalence with another device and the quality of data considered in your clinical evaluation.