OBJECTIVES: Affixing a CE mark to a product means that the manufacturer is declaring that the product meets all legal requirements as well as conforming to relevant product safety directives in the EU. CE marking is mandatory, but only applies to products that are covered by the subject matter of one or more of the New Approach Directives. We aim to clarify the process for obtaining a CE mark. METHODS: Published reviews, our experience and government and industry records were used to outline the complexities of this process, including how to determine the relevant type of classification and the steps that need to be taken to gain a CE Mark.  RESULTS: Medical devices fall into three categories, each of which are governed by a different EU directive: Directive of Active Implantable Medical Devices (90/385/EEC), Medical Devices Directive (93/42/EEC), and Directive of in Vitro Diagnostic Medical Devices (98/79/EC). Each one will encompass guidelines relating to an individual product and whether it is required to bear a CE mark. Once a CE Mark has been obtained a ‘declaration of conformity’ must be signed before you can place the CE mark on your product. This states that the manufacturer takes sole responsibility for the conformity within all the legal requirements to achieve a CE mark. CE marking means that the product can be marketed anywhere in the EU. CONCLUSIONS: A CE mark states that a product has been assessed before being placed on the market and satisfies legislative requirements of the applicable EC directives. It ensures that a product has ‘free-movement’ within the EU as well as permitting the ‘withdrawal of products’, which do not conform. More and more products are required to have a CE mark if they want to gain access to EU market.