What is a Clinical Evaluation Report?
A Clinical Evaluation Report (CER) describes the clinical evaluation process and can be required for all medical device classes. The CER contains the analysis of all inputs from risk management, verification testing, literature review and clinical investigations. The objective is to determine whether there is enough clinical evidence to confirm the safety and performance of the medical device, based on the intended use and the claims made by the manufacturer.
The CER throughout the product life cycle
The initial CER is drafted during the development phase of your device and is a prerequisite for obtaining market approval. Aftermarket release, it has to be regularly updated to reflect data from post-market surveillance, newly discovered risks or indications, and developments in the clinical field.
Qserve's experts acknowledge a good clinical evaluation report and are able to judge the acceptability of the CER for the Notified Body or local authority. Our team has extensive experience in medical writing, data analysis and, as experienced writers of CERs, are able to support any medical manufacturer.
Update your CER
Update your CER with Clinical Data from post Market Surveillance (PMS) and Post Market Clinical Follow-Up (PMCF). The 4th revision of the MEDDEV 2.7.1 Clinical Evaluation states that:
- All Device Classifications need a Clinical Evaluation Report
- Manufacturers must define and justify the frequency of updating their CER's
- CER's need to be updated with new PMS data when there is a change in the current evaluation.