Addition of IFU on local language by distributor - Article 16?

MDRResearcher

Starting to get Involved
#1
Hello everybody!

Could you please help us with a case study:
Distributor adds instructions for use on local language in addition to IFU on English added by manufacturer (inside the secondary packaging box of medical device).

Does this action fall under article 16.2.a) and requires certification and notification?

Is there a difference if the manufacturer supplies the IFU on local language and the distributor only adds it to the box (in relation to the translation beeing performed by distributor)?

Kind regards
 
Elsmar Forum Sponsor

htcoztrk

Starting to get Involved
#2
Hello MDRResearcher,

I do not know much about the translation article yet but I found a white paper which also covers generally about the translation that I am hoping to be helpful to you.

If you ask for my opinion, I believe according to MDR Art. 16, point 3, whether distributor translates the IFU or only put the it into the box, requires these activities to be mentioned on the device/ its packaging or accompanying document: ‘A distributor or importer that carries out any of the activities mentioned in points (a - includes translation) and (b - includes repackaging) of paragraph 2 shall indicate on the device or, where that is impracticable, on its packaging or in a document accompanying the device, the activity carried out together with its name, registered trade name or registered trade mark, registered place of business and the address at which it can be contacted, so that its location can be established.' If I know correctly there are recommended symbols to be used for translation and repacking by third parties other than legal manufacturer. You can have a look also to MedTech Europe's guide.

Best Regards,
Hatice
 
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