Clinical evaluation reports (CERs) are a key part of the technical documentation for CE marking. The report gathers all the information, both positive and negative, to benchmark it against the standard alternatives used in a clinical environment and determines the acceptability of the benefit risk ratio.
For different types of medical device there are different clinical evaluation strategies that can be employed which can potentially increase the amount of clinical evidence available to support conformity to the general safety and performance requirements (GSPRs).
If you need advice, assistance or full authoring of a CER and for any other regulatory or innovation support, see here for more information. Alternatively contact us at [email protected]