Are there any requirements for instructions for use to be in the language of a Member State?
The requirement for products to be supplied with instructions for use is contained within the directive in Annex III, but guidance from the Commission has placed greater stress on the need for such instructions. Regulation 5(6) applies in the UK. It would seem logical that if there must be instructions for use, the user must be able to understand them. The DTI has indicated that products supplied in the UK must have instructions in English; it would be expected that of Member States would insist on similar provisions. Logically, the organization taking responsibility for the design and performance of the product should be responsible, but they will need to demonstrate (via Quality Management Systems or otherwise) that they have control over the manufacturing process as if the they were manufacturing the product themselves.