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Evaluation ViewAttendees 51

Devices (includes Medical Devices and In Vitro Diagnostics)

EU-MDR Notified Body Forum

Wednesday, October 4, 2023
3:30 PM - 4:30 PM EDT
Location/Room: 511E
Early 2023, EU legislators have extended the timelines for transition to EU MDR for medical devices on the EU market with a certificate under the 'old' Directives to 2027 (mid-risk) or to 2028 (high risk devices). To benefit from the extended timelines, manufactures must lodge an application for MDR with a notified body before 26 May 2024 and a contract between the manufacturer and the notified body must be signed before 26 September 2024.

In this session, representatives of several EU notified bodies will share their latest experience and insights on issues and questions around the implementation of the extended timelines, the deadlines for application and contract and other provisions in the amending Regulation. The session will be in Q&A style, where the notified body panelists are first interviewed on achievements and best practices and then enter into an interactive dialogue with the audience. Also, recent joint notified body documents will be highlighted and it will be explained how manufacturers can best apply these documents.