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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
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The introduction of the EU MDR and EU IVDR raised questions for manufacturers about what is necessary to ensure compliance for their devices in the EU market. For manufacturers not based in the European Union, it was a known fact that they would require an Authorized Representative. But with the MDR and IVDR, there are now additional requirements for distributors and importers. A critical requirement for Importers is performing verifications of shipments into the European Union, ensuring that the devices conform with the appropriate regulation.
The timing of the MDR and IVDR has also coincided with Brexit (UK) and Swixit (Switzerland). It has also created its own set of compliance hurdles, including new requirements for Economic Operators based in the UK and Switzerland.
This presentation will address the importer and representation requirements introduced by the regulatory changes, along with timelines for compliance.
A live Q&A with the speakers will follow the presentation.
This event is brought to you by RAPS Vancouver, BC Chapter to encourage knowledge sharing and community development. RAC holders may claim 1.0 RAC recertification credit.
Learning Level: Intermediate
For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 24 hours before the start of the webcast. A live Q&A portion with the speakers will follow the presentation.
René van de Zande, Co-founder of MedEnvoy Global BV.
René van de Zande is co-founder of MedEnvoy Global BV. He has notable achievements as an entrepreneur and executive. He founded Emergo in 1997 and under his leadership, turned it into the leading global medtech regulatory affairs firm with offices in 25 countries. Emergo was acquired by Underwriters Laboratories (UL) in late 2017 and van de Zande continued as managing director through the end of 2019. He has a deep understanding of European regulatory issues.
Daryl Wisdahl, Director of Quality & Regulatory, MedEnvoy Global BV
Daryl Wisdahl has more than 25 years of experience in the medical device industry, specializing in quality management system (QMS) implementation and compliance, and regulatory submissions for medical devices. He has reviewed Health Canada and US Food and Drug Administration (FDA) submissions, and technical (documentation) files for medical device manufacturers around the world. Wisdahl has been a RAPS member since 1994 and has held the RAC-US credential since 2003.
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