Regulatory Strategy for Medical Devices in the EU

When the directives were introduced, they were applied to both new and existing devices. Thus, all device manufacturers are required to establish conformity with essential requirements, so that they can apply the CE Mark of conformity and legally market their products in the EU. 

The CE Mark is not specific to medical devices, but is used generally to indicate to European consumers that a product conforms to applicable European performance and safety requirements. It can be found on electrical equipment, children s toys and safety equipment, among other products. 

The basic mark is illustrated in Eigure 9.2. Depending on the type of product, it may be accompanied by the identification number of the Notified Body responsible for performing specified conformity assessment tasks (see Chapter 10). 

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