Mandatoray Language Requirements for Medical Devicesd

Depending on the Medical Devices Directive (93/42/EEC)- MDD – the member states of the European Economic Area, EEA, can require their own language. All of them have written the mandatory use of their own language for the information on the product and/or labelling depending on MDD annex I, paragraph 13 into their national law transposing the MDD.The MDD says that the manufacturer has to deliver the information in one official language of the member states, which is up to him but he has to consider the contacts with the Competent Authorities and the Notified Bodies.If a manufacturer delivers into other members states of the EEA he has to come to an agreement with the importer on the language:

• Either the manufacturer does the translation, then he has to prove the system for a correct translation to the Notified Body – if involved, or

• the importer organises the translation, then the manufacturer has to control that at least the safety instructions are correctly translated – for his own safety. The product liability remains in any case with the manufacturer, except the manufacturer can prove that the importer did the mistake.

Only the importer is bound by his national law, not the manufacturer in the other country. Therefore only the importer can decide if another language than his own could be used.