Скачать или смотреть Why Medical Device and IVD Manufacturers Need a Regulatory Importer

Importers and authorized representatives are among the economic operators defined in the MDR/IVDR, each with their respective obligations established in the regulations. While many non-EU manufacturers opt to maintain separate importers and authorized representatives, others have chosen to have a single entity take on both roles.

MedEnvoy offers Authorized Representative and Importer services.
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Here are several advantages of having these roles consolidated with a single entity:
The obligations and subsequent regulatory burden on authorized rep have increased under the MDR/IVDR when compared to the MDD/IVDD. This includes that they are now legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer. While the obligations of authorized representatives are more onerous under the regulations, in contrast to importers, they were already accustomed to having obligations under the MDD/IVDD.
Another pro is the consolidation of regulatory activities/responsibilities, particularly as it relates to communication between economic operators. There are several importer/distributor obligations to communicate certain information to the authorized representative.
Lastly, under the regulations both the name and address of both the importer and authorized representative must be indicate on device labeling (permissible locations can vary). Manufacturers that include this information on device labels, particularly those that are limited by the available label space, minimize the amount of labeling space for this information by having a single entity as importer/distributor.

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