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MEDICAL DEVICES
LEGISLATION AND GUIDANCE
INCIDENT REPORTING
PLACING ON THE MARKET
CLINICAL INVESTIGATION
LANGUAGE REQUIREMENTS
DANISH MEDICINES AGENCY
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Medical Devices

The term covers many products which are used in different healthcare settings. They are broadly used for the diagnosis, prevention, monitoring, treatment or alleviation of illness or handicap in humans. Medical devices are healthcare products such as:

  • Diagnostic test kits, for instance blood sugar tests or kits for diagnosing virus infections such as HCV, HIV, etc.
  • Surgical instruments
  • Laser equipment for surgery
  • Hip prostheses
  • Syringes
  • Orthodontic devices and instruments
  • X-ray scanners
  • Implantable cardiac defibrillators
  • Plaster

Contraceptives:

  • Condoms
  • Intrauterine devices

Handicap aids:

  • Wheelchairs
  • Crutches

Custom-made devices:

  • Dental fillings
  • Dentures
  • Custom-made orthopaedic footwear
  • Bandages
  • Prescription spectacles

Medical devices do not achieve their principal action in or on the human body by pharmacological, immunological or metabolic means, but may be assisted in their function by such means.

Last update 08.01.2010 Print this page