Active Implantable Medical Devices Directive

Directive 90/385/EEC covers the placing on the market and putting into service of 'active implantable medical devices' (AIMDs). A product falls within the field of application of the Directive if it complies with the definition given in this Directive. That means, it must be a 'medical device' as defined which is, at the same time, both 'active' and 'implantable'.

The device definition may consequently apply to the system as such or to interchangeable parts intended to form a system together with other devices, therefore for the purposes of the Directive on Active Implantable Medical Devices each part belonging to such system is covered by the Directive regardless of whether such part on its own is 'active', 'active implantable' or not.
 
Examples of AIMDs include:

  1. implantable cardiac pacemakers
  2. implantable defibrillators
  3. leads, electrodes, adaptors for 1. and 2.
  4. implantable nerve stimulators
  5. bladder stimulators
  6. sphincter stimulators
  7. diaphragm stimulators
  8. cochlear implants
  9. implantable active drug administration device
  10. catheters, sensors for 9.
  11. implantable active monitoring devices
  12. programmers, software, transmitters.

A copy of the Directive, guidance on its field of application and clarification of its scope with regard to computers used to program implantable generators can be found on the Europa website.

Directive 2007/47/EC which doesn’t come fully into force until 21 March 2010 but will amend the Medical Devices and Active Implantable Medical Devices Directives following a review of the existing provisions by the European Commission and member states.


Page last modified: 07 February 2008