Understanding the European Clinical Evaluation Report (CER)

BACKGROUND: All medical devices such as wound dressings, catheters, and ostomy appliances marketed into the European Union, as well as neighboring European Free Trade Association states, require a Clinical Evaluation Report (CER) as part of the device technical file. The CER is an objective and thorough assessment of clinical evidence pertaining to the device in order to verify its safety and performance. A CER is initially required to obtain a “Conformite Europeene” or CE Mark, which indicates the device is approved for marketing. CERs should be updated periodically as new information is obtained and must be reviewed at least every 5 years as part of CE mark renewal.

OBJECTIVE: Clinicians, product engineers, marketers, clinical research/regulatory associates, and medical writers may all become involved in the generation of CERs, so it is beneficial for these professionals to have a basic understanding of the process. This review will provide an overview of the CER development process.

METHODS: While the CER is technically a series of related documents, it is best described as a process by which these documents are generated. CER best practices are systematic and transparent reviews of the clinical evidence and should be conducted in a scientific and replicable manner following a well-defined standard operating procedure. Often, a first step in the CER process is a methodologic review of relevant published literature that is later combined with unpublished data in the CER.

OUTCOMES: Generally, a four-step process is followed: 1) Data Acquisition, 2) Data Appraisal, 3) Data Analysis, and 4) CER Document Generation.

CONCLUSIONS: The CER is an objective and thorough review of clinical evidence related to performance and safety of medical devices marketed in the EU and certain neighboring countries. There are 4 distinct stages to the CER development process, which are reviewed in this presentation.