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José M. Montero
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November 2018
MDR 2017/745 Awareness Status and Language Industry
< 1 min reading time

Dear group-fellows, could you help Mediwords to get a better understanding of current MDR2017/745 awareness status so far in the industry?

It won’t take you more than one minute and no single personal data is collected, unless you willingly provide in the last question. Thanks in advance for your time!

https://es.surveymonkey.com/r/MSCJY5B

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Posted by José M. Montero
Asked on November 22, 2018 1:18 am
188 views
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Private answer
Joe Hage

The legislation is an intimidating 175 pages! Here is the PDF for immediate access.

@José, what is the main takeaway?

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José M. Montero

Dear Joe,
Actually we at Mediwords want to know if Medical Device Companies are aware and ready to tackle with MDR2017/745 and its language requirements, we analysed them and wrote a quick to read and clarifying blog entry at: https://www.mediwords.es/languages-behind-and-beyond-mdr-2017-745/
But after attending Medica 2018 in Germany we got the impression that not many of them are really aware of those compliance requirements regarding languages and translation.
That’s the main purpose of the survey and OF COURSE, trying to attract companies to make business with.

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Christine Zomorodian

Jose, have you compiled the survey results yet? Would love to see them.

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José M. Montero

Dear Christine,
Thanks for your interest! I am a little bit puzzled by what I got and that's why the survey is still open to receive more contributions, although the interest rate is now quite lower than used to be :-(
The first which really shocked me was that although more than 3/4 of the respondents knew the MDR requirements, half of them did (planned to do) nothing to comply with them. Obviously you really expect that MedTech companies are quite interesting in avoiding anything making them fail to comply with requirements and which is obviously a drawback for their prospective revenues: languages are an important part to sell devices (not only as a marketing "ace in your hand"), but also for learning materials, reglamentary documentation, etc.
Obviously since they were not acting towards this language requirements, they were not interested in contacts from Language Suppliers.
Franckly, I did not expected these results, moreover after my first Medica attendance (Germany, Nov. 2018), where many little to medium sized companies expressed interest in these requirements.
Of course Big Players comply and take into consideration languages requirements, and some of them have their own Language/Translation Departments, but for little to medium sized companies there is a real risk of lossing part of the cake should they do not comply with language requirements, moreover if their competence does.
I'd love to initiate here a debate around this topic...

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