EU In Vitro Diagnostic Medical Devices Regulation (IVDR)
IVDR - Making Available + Economic Operators (Ch II)

EU In Vitro Diagnostic Medical Devices Regulation (IVDR) IVDR-Art.13_14: Obligations of importers and distributors (Articles 13-14)

Article 13 requires importers to verify that the IVD has been CE-marked, the EU declaration of conformity has been drawn up, the manufacturer is identified, the manufacturer has appointed an authorised representative (if non-EU), the device is registered with the manufacturer per Article 26, the labelling complies and instructions for use are in the required language. Article 14 imposes due-care obligations on distributors: verify CE marking + labelling + the importer's identity on the packaging + due care during storage and transport.

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