Exporting to Europe: Updates on the New EU Medical Device Regulation
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The EU MDR is the largest overhaul to the regulatory framework governing medical devices in 30 years. The Medical Device Regulation will replace the Medical Devices Directive, and was originally slated to go into effect on May 26, 2020. Due to the COVID-19 pandemic, calls from industry were answered to delay the EU MDR’s implementation.
The new MDR rulebook is comprised of 174 pages and will change the regulatory landscape in Europe; it will address technological advancements and focus on a life-cycle approach to medical device regulation and compliance.
Join the Georgia Department of Economic Development for this discussion with a group of experts on the intricacies of these regulations and impart their insight on how your products can be marketed, distributed, and sold in Europe.