The Medical Devices Directives cover the regulatory requirements of the European Union for Medical Devices. There are three different Directives which together cover all medical equipment:

Medical Device Directive 93/42/EEC

covers the placing on the market and putting into service of Medical Devices.

It covers an extremely wide range of products, including, for example:

  • First aid bandages
  • Tongue depressors
  • Hip protheses
  • X-Ray equipment
  • ECG
  • Heart valves
  • Spectacles
  • Dental materials

In Vitro Diagnostic Directive 98/79/EC

covers the placing on the market and putting into service of In Vitro Diagnostic Medical Devices.

It covers devices used in vitro for the examination of a specimen derived from the human body, including reagents, instruments and specimen receptacles.

Examples of IVDDs include:

  • Blood glucose meters, home pregnancy tests, test kits used in hospital laboratories
  • Reagents, calibrators and control materials, whether supplied alone or as part of a kit
  • Analyser systems, analytical instruments, apparatus or equipment
    Point of Care testing and self-testing devices
  • Specimen receptacles (including blood collection tubes) specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro examination
  • Accessories to IVD devices. These are ‘intended specifically by the manufacturer to be used together with an IVD to enable that IVD to be used in accordance with its intended purpose’. A multi-well tile on which immunoassays are performed would therefore be an IVD accessory, while a volumetric flask would be general laboratory equipment

Active Implantable Medical Devices 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:

  • Implantable cardiac pacemakers
  • Implantable defibillators
  • Leads, electrodes, adaptors for 1. and 2.
  • Implantable nerve stimulators
  • Bladder stimulators
  • Sphincter stimulators
  • Diaphragm stimulators
  • Cochlear implants
  • Implantable active drug administration device
  • Catheters, sensors for 9.
  • Implantable active monitoring devices
  • Programmers, software, transmitters.