The Global Medtech Industry: Rewiring Medtech in a Post-Pandemic World

The European Union Council approved legislative changes to the Medical Device Regulation (EU MDR), finalizing a 3-4 ½ year extension on implementation of the new rules for certifying medical devices. The extension, which AdvaMed advocated for alongside its partner Medtech Europe, ensures continued access to life-saving medical technology and innovation and research and development in the EU market.

AdvaMed’s medtech priorities for the 118th Congress highlight opportunities to address the most important issues facing patients and the medical technology industry today.

Get the latest on NMPA’s updated guidance for the clinical evaluation of medical devices.

AdvaMed and its member companies are working with the U.S. government on medtech donations for humanitarian aid following the devastating earthquakes in southeast Turkey and northern Syria.

This publication series explores “Software as a Medical Device (SaMD),” its challenges and the ways regulatory bodies try to address them, as well as the expected development of regulations related to Artificial Intelligence, and Machine Learning in SaMD.

AdvaMed issued a statement from President and CEO Scott Whitaker on the Joint Statement issued by the United States Trade Representative and India’s Ministry of Commerce & Industry at the conclusion of the 13th Ministerial-level meeting of the United States-India Trade Policy Forum (TPF) in Washington, DC, on January 11.  

From MDUFA V and the major investments in semiconductor chip manufacturing in the CHIPS Act, to addressing global supply chain issues and supporting our AdvaMed Accel companies, 2022 was a year like no other.