Division 14.2

On the sales packaging:

• F1the name and address of the manufacturer and the name and address of the authorised representative, where the manufacturer does not have a registered place of business in the Community,

• a description of the device,

• the purpose of the device,

• the relevant characteristics for its use,

• 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,

• the conditions for transporting and staring the device,

• F2in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.