Label Translations - Translation procedure to meet the requirements of MEDDEV 2.5/5

[Philip B]

I'm writing a translation procedure to meet the requirements of MEDDEV 2.5/5. We translate our labels into French, German and Spanish. In the past we have used a general translation service but some native speakers have on occasions commented that some of the translations are odd. I know that there are technical translation services out there but I would imagine these are very expensive. We are only translating product descriptions and simple label warnings.

Does anyone have any experience of what level of translation service meets with NB approval?

 

[Ronen E]

Re: Label Translations - Translation procedure to meet the requirements of MEDDEV 2.5

I'm writing a translation procedure to meet the requirements of MEDDEV 2.5/5. We translate our labels into French, German and Spanish. In the past we have used a general translation service but some native speakers have on occasions commented that some of the translations are odd. I know that there are technical translation services out there but I would imagine these are very expensive. We are only translating product descriptions and simple label warnings.

Does anyone have any experience of what level of translation service meets with NB approval?

It is a quality issue like any other. If some users have expressed dissatisfaction with the outcome, it is a sort of product related complaint. If the complaints occurrence is very low and they are sporadic, or only indicate style mismatch and don’t affect safety or usability, I wouldn’t be concerned. Otherwise you should address the issue according to your SOPs. Either way I would collate the information, analyse/trend and capture it all as a formal record (in the DHF, complaints file or the likes). Then you should be fine with your NB.

 

[somashekar]

Re: Label Translations - Translation procedure to meet the requirements of MEDDEV 2.5

I'm writing a translation procedure to meet the requirements of MEDDEV 2.5/5. We translate our labels into French, German and Spanish. In the past we have used a general translation service but some native speakers have on occasions commented that some of the translations are odd. I know that there are technical translation services out there but I would imagine these are very expensive. We are only translating product descriptions and simple label warnings.

Does anyone have any experience of what level of translation service meets with NB approval?

Philip... Your approach is seen by me as a risk to your company. If your NB has not looked at your translation procedure critically during your MDD assessment, then you are not in good hands.
You have to address professional translation adequately in your procedures and you have to be sure that they are technically correctly translated into all the languages you choose to translate.
If you are trading off your costs to casual translations, you are putting your company into big regulatory risk.
I request you to take a fresh look and address your gaps quickly.

 

[yodon]

Re: Label Translations - Translation procedure to meet the requirements of MEDDEV 2.5

Concur with what others have said. I always view translations as something that requires validation so, irrespective of who translates, I get an independent validation of the translation to confirm it meets user needs.

I haven't found translation services all THAT expensive. Not cheap but they've always been quite good in doing the translations.

 

[Ronen E]

Re: Label Translations - Translation procedure to meet the requirements of MEDDEV 2.5

validation of the translation to confirm it meets user needs.

That’s a challenging definition, isn’t it? You need to find someone who masters both languages (origin and target) well, understands the device well (including tech and clinical sides), and understands usability very well.