Labeling and Instructions for Use - Medical Device Design: Innovation from Concept to Market - page 270

11.2 Standard Symbols and Texts
For all markings and standard symbols refer to the most current guidelines and standard
applicable for the country of sale. The following have been derived from ISO 15223 (ISO,
2007) and from wide experience. Always check with the relevant regulatory authority first.
However, if you work closely with your end-users they will have examples of good practice
from other companies in the medical devices field: on the shoulders of giants!

11.2.1 CE Mark
For all devices for sale in the EC, there must be a CE mark (as per EC guidelines) on the
device ( Figure 11.1 ). This need not be on each component, but on each individual device. For
all devices of Class II and above the CE mark must also contain the Notified Body's number.

There is no such FDA equivalent. The FDA does not license a device; they only give a
company the “ clearance to market ” a device.

11.2.2 Nonsterile Device
Figure 11.2 illustrates the standard nonsterile symbols for use in the EC and the USA.

11.2.3 Single Use Item
Figure 11.3 illustrates the standard accepted symbol for single use only.

Figure 11.1
CE marks (use the format given by the EC): (a) Class I device; (b) Class II and above.

Non
sterile

Non sterile

Figure 11.2
Nonsterile symbols: (a) EC - pre ISO 15223; (b) USA and EC ISO 15223.

2

Figure 11.3
Single use symbol.