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Article 16 of Regulation (EU) 2017/745 & 2017/746: Requirements for distributors and importers requiring the involvement of a Notified Body

couverture EN Regulations (EU) 2017/745 & 2017/746 introduce “new” requirements for distributors and importers who carry out activities
involving the repackaging, supply and/or translation of accompanying documents for devices already placed on the
market under one of the regulations. These economic operators must now put in place and follow the provisions described
in paragraphs 3 and 4 of Article 16 of the regulations.

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Article 16 of Regulation (EU) 2017/745 & 2017/746: Requirements for distributors and importers requiring the involvement of a Notified Body

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