Division 14.1

On the sterile pack:

• the method of sterilization,

• an indication permitting this packaging to be recognized as such,

• the name and address of the manufacturer,

• a description of the device,

• if the device is intended for clinical investigations, the words: ‘exclusively for clinical investigations’,

• if the device is custom-made, the words ‘custom-made device’,

• a declaration that the implantable device is in a sterile condition,

• the month and year of manufacture,

• an indication of the time limit for implanting a device safely.