Classification of Medical Device

Medical device are classified based on the following factors:

  • Is the device has a standalone action
  • The device is in continuous use in the human body for how long
  • Is it an invasive device or surgically invasive medical device
  • Is it an implantable or active medical device
  • Is the Medical Device serves the purpose by the use of certain drug

The classification of medical devices in the European Union is outlined in Annex IX of the Council Directive 93/42/EEC. This annex includes definitions of the terminology used in the medical devices guidance document for the classification of medical device.

The Medical Device are classified into:

Examples refer the table below:

Risk Class Risk Description Example
Class III High Drug eluting cardiac stents, Absorbable Sutures, AIMD
Class IIb Medium-High Ventilators, orthopedic implants, Radiotherapy equipments
Class IIa Medium-Low Surgical Blades, Suction equipment
Class I sterile Low Sterile dressings, Sterile gloves
Class I measuring Low Volumetric urine bag
Class I basic Low Non Sterile Gloves

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