Cases in which obligations of manufacturers apply to importers, distributors or other persons

Importers, distributors or other persons will, with article 16 of MDR and IVDR, have clearer requirements when carrying out changes to packaging to a device, repackaging or other changes to medical devices.

Article 16 describes when manufacturers obligations apply, which modifications are exempted, and which requirements must be met in order for these modifications to be carried out. For additional information see guidelines and Q&A from the Commision.

Questions and answers about re-labeling and repackaging:
MDCG 2021-26 Q&A on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746

Quality system and certification from notifies body:
MDCG 2021-23 Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16 (4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746

Publisert: 27.04.2022

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Cases in which obligations of manufacturers apply to importers, distributors or other persons

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