EU's MDR Effect on U.S. Exports
Instructor:
Casper Uldriks
Product ID: 706316
Training Level: Basic to Intermediate
- Duration: 60 Min
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 Even worse, devices using outdated technology may face a costly surprise when their device is deemed “out of date” and can no longer be marketed.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
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.
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