A obligation of manufacturers of medical devices is to conduct a clinical evaluation. The extent of the clinical evaluation is dependant upon the exact specifications, intended use and used materials of the medical device. Obviously, a more extensive clinical evaluation is required for invasive device than devices that only come into contact with intact skin.
The results of the clinical evaluation shall be reported in a clinical evaluation report (hereafter: CER). The CER shall be part of the Technical Documentation which shall be compiled by the manufacturer. This report shall include both favourable and unfavourable data.
Are you bringing a medical device onto the European market? It is a legal obligation of the manufacturer to conduct a clinical evaluation. CE Medical can assist you with shaping the clinical evaluation and drawing up of the CER.