EU Authorized Representative question

[nozzle]

Hi all,
With the chaos surrounding the UK government trying to implement Brexit the business I work for (based in the UK) has reached the point where we are assuming no deal will be struck and are in the early stages of planning.
This leaves the challenge of appointing an EU rep.

Is there a requirement that the documentation has to be in the language of the country the EU rep is based? So for instance if we appointed a rep in France they would register our products with the French competent authority our documentation would need to be presented in French?

 

[Rincewind]

According to MDR, Art. 10, paragraph 14:
Manufacturers shall, upon request by a competent authority, provide it with all the information and documentation necessary to demonstrate the conformity of the device, in an official Union language determined by the
Member State concerned.

So it depends on the member state. I know in Germany documentation in German and English is accepted.
NBs in Germany also ask the manufacturer if they prefer German or English.

Also all the documentation I have seen that was held by an EU-Rep (acc. to Art. 11, MDR) has been in English. Regardless of where the EU-Rep was based.