Division 8.1

Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer.

This information comprises the data on the label and in the instructions for use.

As far as practicable and appropriate, the information needed to use the device safely and properly must be set out on the device itself and/or, where appropriate, on the sales packaging. If individual full labelling of each unit is not practicable, the information must be set out on the packaging and/or in the instructions for use supplied with one or more devices.

Instructions for use must accompany or be included in the packaging of one or more devices.

In duly justified and exceptional cases no such instructions for use are needed for a device if it can be used properly and safely without them.

X1The decision whether to translate the instructions for use and the label into one or more languages of the European Union shall be left to the Member States, except that, for devices for self-testing, the instructions for use and the label must include a translation into the official language(s) of the Member State in which the device for self-testing reaches its final user.