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:

• Class 1
• Class 1 Sterile
• Class 1 Measuring
• Class 11a
• Class 11b
• Class 111

Examples refer the table below: