Regulatory Open Forum

Do the labelling and IFU translation requirements of the EU MDR prevent the manufacturer from requiring its distributors to pay for the cost of the translations?

The regulation assigns the manufacturer the responsibility to ensure the translations are done, and done correctly. It does not regulate the terms of commercial contracts wrt any profit and cost sharing arrangements.

Hello,

An importatn addition on this: indepent of who is performing the translation(s), the manufacturer stays accountable for them and needs to perform sufficient control on them.

So if the distributor is performing the translations, there should also be an indepent check on those

Greetings,

Hi Anon,

in general I agree with Anne and Franky: If a manufacturer outsources the translation to the distributor, then they remain responsible for the content of the translation - independent from the question of who covers the costs.

On additional aspect: Article 16 of the MDR enables a distributor to perform the translation independently from the manufacturer. In this case the distributor is responsible for the correct translation and has additional responsibilities (e.g. information of the competent authorities and the manufacturer and holding a respective certificate).

Best regards

Christoph