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. The length and effort required to create a CER report can vary significantly depending on many factors. The complexity of a CER can also vary significantly, but the outcome should be the same. The resulting report should be able to be read and understood by a third party at an agency or notified body.
Regulatory requirements for a medical device CER
Europe's Medical Device Regulation (MDR) (EU 2017/745) imposes strict requirements for the content of Clinical Evaluation Reports and these are essentially those described in the EU guideline, MedDev 2.7/1 revision 4 (EU-2016). These include an expert and comprehensive review of clinical data derived from clinical investigations of the performance and safety of the device, and/or the results of studies on equivalent devices. A further requirement is the inclusion of regularly updated systematic literature reviews of the relevant clinical setting (State of the Art) and of published reports relevant for assessing the device's performance and safety. After a successful application, the CER is regularly updated to enable the medical device to remain on the market.
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.
Basically, your CER should include:
- 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
We'll show you what the essentials are for a clinical evaluations report. Our medical writers, with their substantial and longstanding experience in writing regulatory documents, will reduce the challenge of meeting the regulatory demands by producing a clear and concise document that effectively communicates the relevant data to the regulators. Contact us to discuss your multilingual CER writing needs.