Point 13 of Annex I of the directive details what information a manufacturer must supply when placing medical devices in the EU market. As a general principle, each device must be accompanied by as much information as is necessary for people to use it safely, taking into account the training and knowledge of the potential users.
Certain basic instructions must appear on the label with more detailed copy to be included in the enclosed instructions. Instructions are not necessary for selected simple Class I or IIa medical devices if the devices can be used safely without them.
All medical devices must bear a label identifying the name and address of the manufacturer. For devices imported into the community, the label, outer packaging, or instructions for use must also contain the name and address of either the importer or the manufacturer's authorized representative established within the community.
The label must contain several additional details, including information to enable the user to identify the device or other contents, as well as any operating instructions, warnings, or precautions to take. If the device's purpose is not obvious to the user, it must be clearly stated on both the label and in the instructions (point 13.4).
The instructions must contain several particulars, including the details required on the label, any side effects from use of the device, and, as a general rule, details for its correct use, including any specific precautions.
Annex I Section 13.3(a)
(The label must bear the following particulars :)
(a) the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorized representative where the manufacturer does not have a registered place of business in the Community.