Systems and Procedure Packs
2:00 PM - 3:10 PMTue
Speakers
Nathan Da Silva
EU MDR Subject Matter Expert
Edwards Life Sciences
Beatrice Wan
Senior Staff Regulatory Affairs Specialist
Stryker Neurovascular
Keith Morel, Ph.D.
Vice President, Regulatory Compliance
QServe
* Art 22 requirements - procedure packs - including when is a PP a PP and when is it a system? BUDI assignment, UDI/labeling requirements * Accessories, spare parts, compatible devices When is it placed on the market? (Impact of this on determining who is an importer and hence influence on definition of other actors in the supply chain perhaps as economic operators) * Practical examples