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Listen "Parallel importation of medical devices"
Episode Synopsis
The Importance of Article 16 of the MDRArticle 16 represents a major advancement in the regulation of parallel imports, providing more clarity and detail than previous regulations. Specifically, it:Clearly defines what constitutes a parallel import of a medical device.Underscores the critical importance of adherence to essential requirements and harmonized standards.Imposes specific obligations on parallel importers, including verification of technical documentation and device traceability.Allows for corrective and safety measures to be taken in the event of non-compliance.
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