Tackling clinical evaluation head on

Every medical device sold in Europe, irrespective of its device classification, must have an up-to-date Clinical Evaluation Report (CER) as part of its Technical File. The ins and outs of CER development and the steps taken by the responsible manufacturer to successfully provide a compliant CER, based on a comprehensive clinical evaluation strategy; is often unclear to professionals who are not CER specialists. 

A lack of proficient CER experience can lead to various interpretations of the CER guidelines, which can result in varying approaches to the CER process. Also, with the evolving CER requirements, it is becoming more challenging for medical device manufacturers to be confident in their CER approach. 

Presenting adequately supported CERs - especially for less well-established medical devices that lack a significant history of safety and performance – is becoming immensely difficult. The consequences for failing to pass an audit or an inspection could be dire for some businesses, affecting not only their ability to manufacture and sell their products, but also their business reputation; which can have more severe long-term implications.