Classifying Medical Devices - Medical Device Design: Innovation from Concept to Market - page 23

Figure 2.7
Is my device Class I? ( Staffordshire, 2008 )

Table 2.4: Device Classification versus Control Measures

Design Control

Low → High

EU Class I IIa IIb III

USA Class I II III

Selfregulation

High ← Low

2.5 Classification and the Design Process
In both the USA and within Europe the degree of control one applies to the whole life cycle
of the device increases with classification (as illustrated by Table 2.4 ).

The FDA use specific terms for the level of control, which are worth remembering wherever
you intend to work:

Class I means the class of devices that are subject to only the general controls …

Class II means the class of device that is or eventually will be subject to special controls …

Class III means the class of device for which premarket approval is or will be required …
( FDA, 2010 )