EU's MDR Effect on U.S. Exports


Instructor: Casper Uldriks
Product ID: 706316
Training Level: Basic to Intermediate

  • Duration: 60 Min
Attend this webinar to learn about the new EU legal requirements for exporting medical devices to the EU. Learn how to prepare for this MDR requirement and include options for selling your device in the EU and the U.S.
Purchase option for this webinar is currently unavailable. Please contact our Customer Care for more info. Webinar All Access Pass Subscription


Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

Why Should You Attend:

Exporting devices to the EU has new EU legal requirements. A device must have a valid CE mark. You must renew your CE mark certification every three years. If you do not, your products cannot be marketed legally in the EU. If your product is not marketed in the U.S.

Renewing your CE certification takes planning, a lot of planning. It is not automatically renewed. Now firms face an expensive, time consuming and uncertain outcome of renewing their CE mark. The recertification process is not the same for all products. The CE certification review will depend on the MDR classification associated safety issues and performance specifications, not the U.S. classification. Even worse, devices using outdated technology may face a costly surprise when their device is deemed “out of date” and can no longer be marketed.

What do you do when your exported devices do not have a valid CE Certification?

Have you prepared for this MDR requirement? If you are not prepared for this change in the law, your options for selling your device will not include the EU nor the U.S.

Areas Covered in the Webinar:

  • EU legal requirements for exporting devices
  • FDA legal requirements for exporting devices
  • CE certification renewal
  • Redelivery of cargo

Who Will Benefit:

  • Exporters EU Authorized Agent
  • Regulatory Affairs Director
  • Export Logistics Manager
  • Quality Assurance Manager
  • Manufacturing Operations Managers
  • Complaint Department Manager
  • Exporters of Medical Devices to the EU
  • EU Authorized Agent for exporters
Instructor Profile:
Casper Uldriks

Casper Uldriks
Former Associate Center Director, CDRH

Casper Uldriks, through his firm Encore Insight LLC, brings over 32 years of experience with the FDA. He specialized in FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an associate center director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. Mr. Uldriks understands how FDA thinks, how it operates, and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture. His professional credentials include: JD – Suffolk University, licensed in Massachusetts and the District of Columbia; M.Div in psychology – Boston University with internship through Harvard University.

Follow us :



Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).




6201 America Center Drive Suite 240, San Jose, CA 95002, USA

Follow Us

facebook twitter linkedin youtube


Copyright © 2023 MetricStream
Our Policies: Terms of use | Privacy

PAYMENT METHOD: 100% Secure Transaction

payment method