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How Parallel Distribution Of Medical Devices Could Be Impacted By German Cases

This article was originally published in SRA

Executive Summary

Is it legal for distributors of specifically re-labeled medical devices to carry out parallel import within the EU, or do they have to perform supplemental conformity assessment procedures as they are considered to have taken on the role of the manufacturer? Frank Pflueger discusses the EU-level legal cases being raised by Germany which are challenging parallel distribution of medical devices and IVDs.

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