OSMA Update: Regulatory Initiatives in the U.S. and EU

What initiatives are shaping the orthopedic device regulatory landscape in the United States and European Union? Ryan Belaney, Vice President of the Orthopaedic Surgical Manufacturers Association (OSMA), along with OSMA representatives, will discuss the latest trends and areas of improvement at FDA regarding medical devices, including MR labeling & testing and biocompatibility. The panel will also provide insights from a 2023 Notified Body OSMA meeting that discussed the current state of implementing the EU’s Medical Device Regulation (MDR). Attendees will gain valuable knowledge about how OSMA is working with industry partners and regulatory bodies to address these issues and ensure the development and distribution of safe and effective medical devices for the orthopedic industry.

Learning Objectives:

• Understand FDA’s current stance on MR labeling & testing, as well as biocompatibility
• Review the current implementation of EU MDR
• Learn how orthopedic companies, through OSMA, work with regulatory bodies to address today’s pressing issues