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In brief

On October 21, 2021, the MDCG published a new question and answer document on the procedures governing the relabeling and repackaging of medical devices under Article 16 of the MDR and IVMDR.


In particular, the document provides clarifications on the scope of relabeling and repackaging provisions, also with respect to “legacy devices” (i.e. medical devices placed on the market after the MDR application date and until May 26, 2024 provided that there are no significant changes in their design and intended purpose), and on when relabeling and repackaging activities are deemed to be “necessary in order to market the device in the relevant Member State”, so as to explain when the performance of these activities results in the assumption by the relevant distributor or importer of the obligations incumbent on manufacturers.

The document also provides clarification on the cases where distributors and importers must notify the manufacturer and the competent authority of their intention to make a relabeled or repackaged device available on the market and what information shall be provided along with the notification. Lastly, the document explains to which notified bodies importers and distributors may apply for the purposes of obtaining the certification attesting that their quality management system complies with the applicable requirements.

Author

Roberto Cursano is a counsel in Baker Mckenzie since 2007 in Rome, Italy office. His practice focus more in pharmaceutical and healthcare law matters and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts.

Author

Riccardo Ovidi is an associate in Baker McKenzie's Rome office.

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