Procedure for Translating User Documentation to comply with MEDDEV 2.5/5

A

andreiafilipaf

#1
Hi

I want to define a procedure for translating user documentation, and to comply with MEDDEV 2.5/5.
Does anyone have a good receipt for this procedure so that I do not forget about all relevant issues?

Thank you!!!
Andreia
 
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RA Guy

Involved In Discussions
#2
There have been other discussions related to this "requirement" elswhere on this site:
Manual Translation procedure for the translation of our manuals into other languages

I would suggest, the following may be important aspects to consider if you write a formal process:

Supplier management - qualification and monitoring of any translation or translation validation services your company uses

Risk management - when translating labels, focus on the aspects of safe and effective use of the device and consider the user of the device (for example is the device for home use or professional use or both). Durinig product development, can symbols or human factors engineering mitigate risk of a device being used by different language groups?

Validation of translations - most translation service providers, even those that have some specialization in medical technology will not provide the best translations on first pass. This is often due to literal translations of common terms that may have specific meaning when used in the context of your device. It is common to use post transation reviewers who both speak/read the translated language fluently and who are familiar with the technology/medical speciality of the medical device.
Most importantly, don't go to translation until your "native" language labeling has been optimized in terms of risk management and validation. Investing the time in developing concise, effective, easy to use labeling should lower both translation costs and improve the quality of the translations.

Best of luck.
 
C

curiousone

#3
HELP! I am trying to find a definitive answer regarding translation. Must all information found on packaging be translated? Our product information can be found either on the packaging or on the product insert. How much of the marketing information must be translated? Do we have to translate all information found on the packaging or insert or just the instructions for use. I would greatly appreciate any and all information.:thanx:
 

Ronen E

Problem Solver
Moderator
#4
HELP! I am trying to find a definitive answer regarding translation. Must all information found on packaging be translated? Our product information can be found either on the packaging or on the product insert. How much of the marketing information must be translated? Do we have to translate all information found on the packaging or insert or just the instructions for use. I would greatly appreciate any and all information.:thanx:
The answers depend on the market(s) you will be selling into (different regulations for different markets). Those would be...?
 

Ronen E

Problem Solver
Moderator
#6
The European Union mostly.:thanks:
MDD Article 4:

4. Member States may require the information, which must be made available to the user and the patient in accordance with Annex I, point 13, to be in their national language(s) or in another Community language, when a device reaches the final user, regardless of whether it is for professional or other use.
From Annex I, 13.1:

...This information comprises the details on the label and the data in the instructions for use.

As far as practicable and appropriate, the information needed to use the device safely must be set out on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging. If individual packaging of each unit is not practicable, the information must be set out in the leaflet supplied with one or more devices...
For more details, as well as specifics about the types of information that are mandatory under this clause (and therefore may be subject to translation requirements) - consult annex I point 13 in its entirety.

Cheers,
Ronen.
 

c.mitch

Quite Involved in Discussions
#7
For EU, there's a document from the Team-NB.
Have a look at this:
http://www.team-nb.org/index.php?option=com_docman&task=doc_download&gid=946&Itemid=38&lang=en

The document is somewhat old (2008) but I use it this way:
-if a language is mandatory, no need to look further, translate it
-if it's not, go to the official agency of the country to see if things have changed.

Unfortunately, there's no document at the EU level which gives the translation requirements for each country. You have to search in the websites of each country.

Regards.
 
C

curiousone

#8
Could you please explain to me what this means: "in red the MS not yet checked".
I thank you for all your help! I was unsure of "what" was all considered labeling. My concern was whether or not we were required to translate all text on the labeling or just the instructions for use.:thanks:
 
Last edited by a moderator:
C

curiousone

#9
I have two questions regarding the use of pictures and/or symbols for instructions for use: If we use pictures to depict the instructions for use, must we also use the statement "Instructions for Use" and then of course have to translate that phrase? Also, is it acceptable to use pictures and/or symbols to depict the IFU's and possibly eliminate the need for verbiage? Of course, I understand the pictures/images must clearly represent the IFU's to eliminate any risks.
I would appreciate any expertise on this matter. I thank you in advance for your help.:thanks:
 

c.mitch

Quite Involved in Discussions
#10
Hi,

I would say it depends on the class of your device. If it is class I and VERY simple and its intended use is well-known without possible confusion, you could argue that you meet the essential requirements #13.x, with normalized symbols only.

Regards,

Mitch.
 
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