EU Medical Device Regulation May Spur Litigation Uptick

Law360 (May 14, 2021, 5:21 PM EDT) -- Regulation (EU) 2017/745 on medical devices,[1] which will become fully applicable in the European Union on May 26, may have far-reaching implications for both EU and U.S. products liability litigants for years to come.

In contrast to areas of greater historical international harmonization, such as good clinical practices, the EU framework and standards for the marketing of medical devices — and the capture and visibility of device performance information in the post-marketing setting — are areas in which the EU has, since inception in the 1990s, diverged from the U.S. approach.[2]

Historically, the following have been notable differences between the two...

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