Medical Device Import/Export Translation Requirements for each country

Does anyone have a list, or a link to a list, detailing export/import requirements for each country in relation to Directive 2007/47/EC and translating manuals/software (For example, I saw the post about Royal Decree 1591/2009 for Spain..)

I've been googling each country individually but thought if I could find a list it would save me some time

Is anyone else as distressed as me with trying to get to grips with the translation requirements for software in a medical device by March 21st

Re: Import/Export translation requirements

KAMay said:

Does anyone have a list, or a link to a list, detailing export/import requirements for each country in relation to Directive 2007/47/EC and translating manuals/software (For example, I saw the post about Royal Decree 1591/2009 for Spain..)

I've been googling each country individually but thought if I could find a list it would save me some time

Is anyone else as distressed as me with trying to get to grips with the translation requirements for software in a medical device by March 21st

Click to expand...

Someone here may be able to help you with a list, for translations you may try This Link.

Umang

Re: Import/Export translation requirements

Hi... you may check this site: http://www.ce-mark.com/neweu.pdf

Re: Import/Export translation requirements

Hi...I've been struggling with this myself. How is everyone tackling this in their procedures?

I have been trying to write the procedure, attached is what I have come up with so far. Any comments/criticisms would be appreciated.

This may help. The site has a lot of regulatory information and this is a link to a table with a list of countries and the links to the various ministries.

http://www.rainfo.com/COUNTRY/WorldLinks.htm

Attached are several documents I use when trying to figure this out.

Thanks Blewispunk, these lists are great..

My only question - I was under the impression that 'for professional use' was no longer an excuse to not translate into the National language, all of these lists still have that as an option for some countries, is that right?

I can only speak for the Greek transition law of the MDD:
Class I and ClassIIa can not have Greek instructions if they are for professionals' use, ANDDDDDD you get a perimission from the National Competent Authority.

Which means that for whatever products you have for professional use, you must get permission from the Greek NCA ("EOF": www.eof.gr). If you do decide to do it, i wish you good luck with all my heart

But here comes another point, as I mentioned earlier: having an "open" market in Europe, means that suppose you are in England and you sell your product to a customer in England for example, and this customer then ships the product to a company in Greece. The Greek NCA will have to run after the manufacturer. But you did not do something wrong.

In this way, everybody who does not have instructions/labels for each specific country, must be printing on the labels "not for sale in A C B D E countries". Can you imagine what will happen ?

I am seriously thinking of informing a member of the European Parliament on this, and have him file a formal question at the Europarliament. DG Sanco must look into this.....

Thanks

Alexisss said:

But here comes another point, as I mentioned earlier: having an "open" market in Europe, means that suppose you are in England and you sell your product to a customer in England for example, and this customer then ships the product to a company in Greece. The Greek NCA will have to run after the manufacturer. But you did not do something wrong.

In this way, everybody who does not have instructions/labels for each specific country, must be printing on the labels "not for sale in A C B D E countries". Can you imagine what will happen ?

I am seriously thinking of informing a member of the European Parliament on this, and have him file a formal question at the Europarliament. DG Sanco must look into this.....

Thanks

Click to expand...

Very good point, it almost strikes me, that to cover all possibilities you need to have 22 versions of the IFUs etc (I think there is 22 languages) That is a financial nightmare for us!