The upcoming EU MDR changes are significant, potentially impacting your device classification and the need for clinical data. Considering the overall timeline – including ISO 13485:2016 (March 2019) and MDSAP (if selling in Canada; Jan. 2019) – it will be difficult to get on notified bodies’ schedules. The time to plan and act on these changes is now. Your technical files, design dossiers, quality system documents, clinical plans, labeling (including UDI), software, and more will be affected. Plus new requirements are coming into play, including Eudamed and periodic safety update reports (PSURs).
This presentation will describe what to do now, what to keep your eye on, and show real-world examples of how industry is working through the changes.
5pm – 6pm Registration and Networking
6pm – 7pm Presentation
7pm – 9pm Networking
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