Medical Device Classification EU & US FDA

Classification of Medical Device

Medical Device are classified based on the following factors:

  • Does the device have a standalone action?
  • How long the device is in continuous use in the human body?
  • Is it an invasive device or surgically invasive Medical Device?
  • Is it an implantable or active medical device
  • Does the Medical Device serve 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 the Medical Device.

The Medical Device are classified into:

Examples refer to 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

INDIA – Bangalore
+ 91 994 591 2081
Phone / WhatsApp

USA – Chicago
+1 630 696 1293
Phone / WhatsApp

GERMANY – Bremen
+49 2161 990 8831
Phone / WhatsApp

LiveZilla Live Chat Software