Roger's citation is correct - the DofC needs to be in at least one official Member State language and then translated as needed. In my experience, often if you have in English only is fine - the actual content of DofC is fairly standard so understanding what is there is fairly well known. You would not need to translate to German if not sold in Germany/Austria. As a note, in the future the DofC will be uploaded to EUDAMED, so multi-language translations might be needed at that point in time.
------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------
Original Message:
Sent: 24-Mar-2020 05:50
From: Maud Giorgi
Subject: Declaration of Conformity - Translation requirements
Often people write it in English at least and/or in the official language of the notified body. Then you have to translate it in every required national language (if demanded).
Even if this should be upfront translated I know very few companies that are doing this. And national competent authorities like BE, DE, FR never ask us a translated one. Even if this should be translated.
------------------------------
Maud Giorgi
QMS & RA Manager
Lausanne
Switzerland
Original Message:
Sent: 23-Mar-2020 03:49
From: Soumya Rajesh
Subject: Declaration of Conformity - Translation requirements
Dear RAPS members,
I have a question regarding the translation requirements of EU MDR Declaration of Conformity (DoC). I am aware of the fact that DoC needs to be translated into the official languages of EU member states. However, I am not sure if it requires translation even if the device is not placed in certain EU member states. For example, if the device is not sold in Germany/Austria, do we still required to have DoC in the German language?
Any guidance is highly appreciated.
Best regards,
------------------------------
Soumya Rajesh
Quality and Regulatory Affairs Manager
Den Haag
Netherlands
------------------------------