Essentials of European Medical Device Regulatory Affairs - October 2019

MDR Transition Strategy

• Is my QMS and technical documentation ready? • Is my supply chain ready? (distributors, importers) • When does my certificate expire? • Is my current Notified Body designated to the MDR? • Does my current Notified Body have the correct scope for my devices? • Do I want to make any significant design changes soon? • What about my new devices?

Notified Body Designation: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.main

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Implementation – priorities & challenges

• Notified Body Resource

• Eudamed & UDI system

• Expert panels

• Implementing / delegated acts (43 in MDR), common specifications and guidance.

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