The active implantable medical devices Directive sets essential requirements with respect to medical devices powered by an electrical energy source. These medical devices are produced for implantation in the human body. The active implantable medical devices Directive came into force on 1st January 1993 and it has been a legal obligation since 1st January 1995. Now, active implants may no longer be traded without the CE Marking. The essential requirement in the Directive can be divided into two categories, viz.: the general requirements and requirements that apply to the design and construction of the active implant. These latter requirements focus on the technical safety, biocompatibility and sterility of the active implant. Examples of active implants are, among other things, implantable neurostimulators, hearing-aids and insulin pumps. However, the Directive defines term "active implant" quite broadly, and not only the implant itself must bear the CE Marking, but also the associated accessories and software without which the implant cannot be operated.