Vancouver, BC Chapter Event: MDR/IVDR and Economic Operators, plus UK RP and Swiss CH REP

1.0
RAC Credits
Chapter Events Chapter Events
Thursday, 07 April 2022 (5:00 PM) - Thursday, 07 April 2022 (6:00 PM) Pacific Time (US & Canada)

Member: $0
Nonmember: $25


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 Objectives

Participants will:

  • Understand the impact of the EU MDR/IVDR Economic Operators requirements on manufacturers and distributors
  • Review new UK MHRA requirements for importer and Responsible Persons
  • Examine the post-Swixit import requirements from Swissmedic
  • Review timelines for new EU, UK and Swiss requirements by device classification 

Who Should Attend?

  • Medical Device and IVD QA and/or RA Managers/Directors or anyone responsible for compliance with EU, UK or Swiss regulations.
  • Logistics/operations teams that are involved with the labeling or shipping of devices into the EU, UK and Switzerland   


Audience Learning Level

Learning Level: Intermediate 

Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

How Do Webcasts Work?

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. 

RAPS Membership

RAPS membership provides vital information for regulatory professionals and a place for networking and invaluable connections. Now is a great time to explore the many benefits to RAPS membership, including the Member Knowledge Center and our award-winning, private online community, Regulatory Exchange. Find out more about RAPS membership today.


Featured Speakers:

René van de Zande

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

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.

Thank you to our Platinum Chapter Sponsors:




Cancellation Policy

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

All cancellation requests must be submitted in writing to raps@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email raps@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance at the following the webcast.

Questions

Contact the RAPS Support Center:

Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org

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