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Importer And Distributor Repackaging And Relabeling In The EU: New Guidance Published

 
• By Amanda Maxwell

It is vital that importers and distributors in the EU who are repackaging and relabeling medical devices know their responsibilities under the new MDR and are aware that they could be moving into manufacturer territory. New guidance spells out the new rules.

3d render of Europe map Earth globe

To help importers, distributors and other parties understand what responsibilities apply to them when it comes to relabeling and repackaging, the European Commission’s Medical Device Coordination Group has published a new guidance document, MDCG 2021-26 Questions and Answers on repackaging & relabeling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746.

The eight-page long document is focused entirely on Article 16 of the MDR and IVDR regulations, which covers cases in which obligations of manufacturers

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