Scope

Medical devices (as a whole) include any instrument, appliance, software, etc. used for the purpose of prevention (e.g. vaccine-delivery devices), screening (e.g. mammography for breast cancer), diagnosis (e.g. use ultrasound system) treatment, or alleviation of disease. Medical devices are currently regulated under three main Directives covering:

  1. Active Implantable Medical Devices (AIMD),
  2. Medical Devices (MDD)
  3. In Vitro Diagnostic Medical Devices (IVDD)

AIMD is classified as a device which must rely on a source not provided by the body or gravity and be designed to be introduced into the body with the intention to remain there following the procedure. The directive specifies that these products should meet essential safety requirements in terms of function, sterility, material compatibility, marking, user instructions and design documentation. In addition there are requirements for type approval, production quality management, clinical investigation and manufacturer registration.


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