International labeling standards are as follows:
- The CE Mark must appear in a visible, legible and indelible form on the device or its sterile pack and on the instructions for use.
- As far as practical and appropriate, information needed to use the device safely must be on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging (MDD).
- Instructions for use must be included in the packaging for every device.
- Where appropriate, the information should take the form of symbols.
