Managing Change in Global Medtech Regulation: A Tale of Two Systems

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ARTICLE SUMMARY:

US and European regulators are moving in opposite directions. How should the medical device industry cope?

In psychology, cognitive dissonance results from trying to maintain contradictory beliefs or positions simultaneously because humans prefer internal consistency. Welcome to the current state of global medical device regulation, particularly in the US and Europe. I recently attended two US medtech conferences and both featured sessions on international medical device regulation harmonization, a topic that has been under discussion for years. Yet, at the same time, we are seeing perhaps the clearest divide ever between the US and Europe since Pangaea split, with their respective regulatory regimens rapidly moving in opposite directions.

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