European Union Device Regulation (EU MDR)
November 3, 2021 - CA USCompliance4All
compliance4all14@gmail.com
Phone:8004479407
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. Why you should Attend: The EU MDR will be effective in May 2020. Products intended to be imported into the EU must conform to these new regulations. Arrangements must be made with a Notified Body, an Authorized Representative and a Person Responsible for Regulatory Compliance.