Classification of Medical Device
The medical devices are broadly classified into class I/ class Is, class Im, class IIa, class IIb and class III based on its intended use & the technology used in the medical device while getting the intended use fulfilled.

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
  • Leads to improved sales and greater customer satisfaction

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:

  • Class I
  • Class I Sterile
  • Class I Measuring
  • Class IIa
  • Class IIb
  • Class III

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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