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Implementing New Responsibilities for Economic Operators under the EU MDR
Implementing New Responsibilities for Economic Operators under the EU MDR


 
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Product Code: WB-7271
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About the Product
Includes 1 Hour Windows Media Video File and PowerPoint presentations for immediate download.


The MDR, published in in May 2017, has updated and clarified a variety of roles and responsibilities within the medical device supply chain, including those of economic operators. This way the MDR triggers responsibilities new regulatory responsibilities in the supply chain for previously unregulated company entities and third parties by introducing new regulated roles as importer and distributor. For example, third party fulfillment providers used in the supply chain for tax purposes may suddenly qualify as importers that fulfill a crucial regulatory gateway function for devices to the EU. These requirements have not only broadened regulatory due diligence requirements regarding other entities such as importers and distributors, but also necessitate review of existing supply chain related contracts.

The authorized representative obligations have increased significantly and authorized representatives are required to fulfill an independent surveillance role, which may lead to corporate governance issues for companies with their own internal authorized representative. Authorised representatives are jointly and severally product liable with the manufacturer and must report non-compliance to the authorities, which will change the manufacturer –authorized representative relationship profoundly. New requirements regarding manufacturer dossier obligations may have a great impact on OBL manufacturing.

  • Manufacturer, Authorized Representative and Own Brand Labeling
  • How to deal with the new authorised representative requirements
  • Methods to better prepare OBLs for new requirements and OBL contract provisions to permit full access and cooperation

Importer and Distributors

  • Who are importers and distributors under the MDR?
  • Review obligations for importers and distributors
  • Impacts of the new obligations on a manufacturer’s supply chain


Speaker:
Erik Vollebregt
Partner
Axon Lawyers


Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:
  • Regulatory Affairs
  • Quality Assurance
  • Compliance
  • Legal Counsel

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