The Medical Device Directives and Their Impact on the Development and Manufacturing of Medical Implants

Abstract

The introduction of a legal framework for the supply of medical implants is discussed with reference to the Active Implantable Medical Device Directive and the Medical Device Directive. The definitions of medical device and manufacturer are discussed. The application of the Directives to device/drug combinations is considered. All implants must meet certain essential requirements to ensure that they do not harm the patient, clinician or any third party. For most implants this will be indicated on the product or its packaging by CE marking involving an independent organization called a Notified Body; the latter are appointed by the Competent Authority of the Member State. Devices are classified in proportion to the risk associated with them. The steps needed to be taken by manufacturers are outlined and the verification options discussed. The role of standards and the new approach to writing them in Europe is presented. After placing a product on the market, the manufacturer must set up a system of post-market surveillance, including a vigilance procedure, in order to monitor product performance. Individual Member States can exercise the safeguard clause when a product appears to have had the CE marking incorrectly applied.