31998L0079R(01)

Corrigendum to Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (Official Journal of the European Communities L 331 of 7 December 1998)

On page 15, in Article 22(3), second sentence:

for: '. . . as from the entry force of this Directive.`,

read: '. . . as from the entry into force of this Directive.`;

and on page 20, in Annex I(B), point 8.1., add the following paragraph:

'The 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.`