The European Union Medical Device Regulation (EU MDR) will be fully implemented and in effect by May 2020. Manufacturers who are submitting to or already have products cleared for marketing in the EU will need to bring their quality systems into compliance soon, or otherwise face increased obstacles. There are a number of intricate facets to this new regulatory framework, which can make it difficult to navigate. So, how do you manage the transition?
In this white paper, “Managing the Transition to EU MDR Regulations,” learn more about the MDR and how it will impact your medical device organization. Taking a higher-level approach to understanding the regulation, the paper will help you understand the areas of greatest concern to manufacturers and ways to prepare for the transition.
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