Webinar: Regulatory Importer Responsibilities & Best Practices

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Join us for an in-depth presentation on December 6th from 10 AM to 11 AM CST, exploring the critical role of the Regulatory Importer within the EU MDR and IVDR frameworks. Discover why the Regulatory Importer’s responsibilities extend beyond those of distributors, covering essential aspects such as device registration, UDI requirements, and post-market surveillance. In this session, manufacturers will gain valuable insights into navigating regulatory requirements and ensuring device compliance within the European market.

Learning Objectives:

• • Differentiate Responsibilities: Identify the unique roles and responsibilities of a Regulatory Importer in contrast to those of an Authorized Representative.
  • Assess Compliance Impact: Evaluate how choosing an independent Regulatory Importer can influence device compliance and market access.
  • Clarify Legal Requirements: Understand the specific obligations and legal framework for Regulatory Importers as outlined in Article 13 of the EU MDR and IVDR.
  • Implement Best Practices: Develop strategies for effective compliance management to mitigate risks associated with regulatory obligations.

Speaker:

Edgar Kasteel, Partner & CEO

Biography:

Edgar Kasteel founded and managed the Distribution Division of Emergo until its spin-out into Luctor Medical in 2017. With the enactment of the EU MDR and IVDR, he pioneered the development of the “Independent Importer” service and established MedEnvoy Global in 2020 as a sister company to Luctor Medical. Edgar brings extensive experience in foreign direct investment, logistics, and distribution.

This webinar has now expired:

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