Presentation by Gert Bos and Coenraad Davidsdochter from the 12th China International Medical Device Regulatory Forum
Watch the online video presentation of Gert Bos and Coenraad Davidsdochter from the 12th CIMDRF, from September 2021.
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Two presentations in one video with first Gert Bos who presented the topic Effect EU MDR on combination products, with two basic types of combination products. The first one is about Device-Drug combination products (Rule 14 of MDR) as medical devices. The other one focuses on Drug-Device combination (article 117 of MDR) ones falling in the pharmaceutical regulation.
Coenraad Davidsdochter presented the new European AI Regulation proposal. Which has been in the consultation mode and which now has been processed further to be put into a new regulation. Coenraad mentions an introduction to the proposal, the structure and different chapters as there are. And after that a deep dive in the new requirements and what this means for manufacturers.