The actual requirements depend on the complexity of the device, but the typical route to getting the CE mark is as follows:
1. Determine which of the following EU Medical Directives is applicable:
• Active Implantable Medical Devices (90/385/EEC modified by 2007/47/CE)
• In Vitro Diagnostic Medical Devices (98/79/EC)
• Medical Devices (93/42/EEC modified by 2007/47/CE)
2. Meet the requirements of the relevant Directive. This will include:
• Appropriateness for intended use
• Safety
• Acceptable risk vs. benefit
• Effect of transport & storage
• Labelling and other device-specific elements
3. Compile the Technical File. This will include:
• Product description and specifications
• Manufacturing information
• Risk management documentation
• Design verification and validation test reports
• Clinical evaluation
• Labelling
4. Carry out a Conformity Assessment. The exact nature of this depends on the device classification, but will typically include an inspection of the design and QA systems.
5. Declaration of Conformity. A statement by the manufacturer to confirm that its device meets the requirements of the Directive, has undergone the appropriate conformity assessment procedures and is designed, manufactured and tested in accordance with the technical file.