Getting to Yes from Regulators to Payers and Beyond - the Decision-Maker Gauntlet
Regulatory, Quality and Good Manufacturing Practices
Implementation of the MDR/IVDR remains problematic. Relevant and necessary implementing acts remain in limbo, notified body capacity does not appear sufficient to be able to do the necessary reviews in advance of the deadlines and many additional technical questions remain unresolved. This panel will address the fundamental issues in implementing the regulations, as well as attempt to offer perspective on potential mechanisms that could be utilized to reduce the review backlog and ensure products can remain on the market in the EU. The panel will have a wide representation from industry, regulators, consultants and notified bodies. The session will provide a comprehensive update of the scenarios that are likely to unfold in the coming months and offer insight into how these may be addressed.