Requirements for distributors under MDR: translation

Cybel

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#1
Hi all,
the Article 16 "Cases in which obligations of manufacturers apply to importers, distributors or other persons" of MDR, point 2. (a) states:
“...provision, including translation, of the information supplied by the manufacturer relating to a device already placed on the market...“ What does already placed on the market mean here?
My distributor sends to me the translation before I place the device on the market, so the distributor does not provide translation of the IFUs relating to a device already placed on the market.

Do requirements of Article 16 point 4 (informing competent authority of translation and having a certified QMS for translation) apply or not?

Thanks
 
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