'Labelling' for IVDs means all the information supplied by the manufacturer related to product use.
Annex I, section 8.1 of the IVD directive requires manufacturers to supply the information necessary for the safe and proper use of the device and that this information must be set out on the packaging and/or in the instructions for use supplied with the device itself.
In each country of the European Community, national regulations may require translation of the information supplied by the manufacturer into the local language(s). The use of symbols in accordance with harmonised European standard EN ISO 15223-1 is therefore recommended to help avoid translation of certain basic information.
It is also possible for manufacturers to provide the information in a format other than paper (for example by CD-ROM) or through different means of supply, such as the internet. For IVDs, therefore, 'e-labeling' is permitted, but with certain restictions and additional requirements, as explained in the official guidance document MEDDEV 2.14/3.
GEMAR can help with preparation and translation of labelling and also with compliance with the e-labeling guidance - please contact us for further information.