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Supply Chain Management under the MDR, Brexit and Swixit

A session by René Van De Zande
Former: Founder & CEO, Emergo, Current: Partner & Commercial Director, MedEnvoy Global

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About this session

As a result of the MDR, Brexit and Swixit, manufacturers need to be fully aware of how these changes may impact their current and future supply chain Europe. The roles of players in the supply chain such as importers, distributors and third-party logistic providers need to be understood so compliance to the regulations throughout the supply chain will be achieved. In addition, how will these changes impact the responsibilities of the European Authorized Representative and the UK Responsible Person. And what about Switzerland (Swixit)?

This session will discuss the impact on the supply chain in detail with a particular focus on the importer and representative in the EEA and UK. We also provide a status update on Swixit.

  • Meaning of “making available” and “placing on the market”
  • Types of relevant Importation; physical, fiscal and MDR
  • Role of the Importer and Distributor in the EEA and UK
  • Role of the European Authorized Representative and UK Responsible Person
  • Managing overlapping responsibilities between the Importer and European Authorized Representative in the EEA, and between the Importer and the UK Responsible in the UK
  • Importance of the use of contracts and quality agreements in managing regulatory compliance throughout the supply chain
  • Swixit Update

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