A C D E F G H I L M P R S T V W Y

Classification of Medical Product

According to European Union Medical Devices Directive (MDD), medical products/devices are any article, whether used alone or in combination, to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment of medical conditions. 

  • Class I/1 products are the ones with low risk. Examples include products with transient contact with the body and reusable surgical instruments.
  • Class IIa/2A classifies for products with medium risk, with longer than transient contact with human body such as invasive surgical products.
  • Class IIb/2B products impose medium to high level risk, with very long contact with body such as implant products.
  • Class III/3 are for products with vital life-supporting function.

In Digital Light Processing (DLP) 3D printing, the highest biocompatible materials mostly falls on class IIA/2A, with few exception for highly-innovative implant materials that goes into class IIB/2B. Furthermore, there are already progressive efforts in manufacturing 3D printer and materials for class III/3 products.