European Union Device Regulation (EU MDR)

from Compliance4all

Overview:
The EU MDR replaces the MDD and expands the requirements for conformance. The MDR contains 174 pages with 123 "Articles" in 10 "Chapters" and 17 "Annexes".

In contrast the MDD has 60 pages. New requirements are added and existing requirements are expanded. The MDR is effective May 2020 leaving limited time to prepare.

These new and expanded requirements will be explained. Attendees should have a reasonable understanding of FDA regulations. (from )

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