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What is Procurement in Medical Device Regulation about?
The document provides an introduction to new medical device regulations in the EU. The Medical Device Regulation and In Vitro Diagnostic Medical Device Regulation will replace existing directives and create a robust regulatory framework recognized internationally. They establish transition periods ending in 2021 and 2022, and clarify requirements for manufacturers, notified bodies, and CE marking while emphasizing clinical safety and data.
- Author
- dicev84894
- Language
- EN