Under the Directive 93/42/EC the requirements regarding the language in which the information had be to supplied by the manufacturer, was quite confusing and subject to misunderstanding. Indeed, the Directive 93/42/EC says that the language can be the official one from the country or the official one from another EU country.

The MDR and IVDR say that documents have to be provided by the manufacturer in the language which shall be determined by the member state. Concretely, under the MDR 2017/745 and MDR 2017/746, the manufacturer will have to check the linguistic requirements near each Health Authorities of the EU member states, to see what they authorise.

This can be complex and time consuming.

Recommended Reading

MDR 2017/745 Annex II Chapter 2 – Information to be supplied by the manufacturer.