Background The Medical Technology Evaluation Programme

(MTEP) within the National Institute for Health and Clinical Excellence (NICE) was set up in 2009; this is a programme focusing specifically on the selec-tion and evaluation of new or innovative medical technologies (including devices and diagnostics). One of the requirements to enable a product to be evaluated by the MTEP is that the device is CE marked or it will be CE marked within twelve months. This report was produced to describe the CE marking process for different categories of medical technology and the types/quality/quantity of evidence that are required for each category. Summary Medical devices cannot be placed on the European marketwithout conforming to the strict safety require-ments of the European Union; one of these require-ments is the affixation of the CE conformity mark. This article is an overview of the CE marking process only; it is not a document that should be referred to on its own. All manufacturers wishing to gain aCEmark should refer to the official documents. Legislation Collectively known as the Medical Device Direc-tive (MDD), this core legal framework consists of three directives that regulate the safety and mar-keting of medical devices in Europe and came into effect in the 1990s. The three directives are the