How Does Medical Device Regulation Perform in the United States and the European Union? A Systematic Review

Policymakers and regulators in the United States (US) and the European Union (EU) are weighing reforms to their medical device approval and post-market surveillance systems. Data may be available that identify strengths and weakness of the approaches to medical device regulation in these settings.We performed a systematic review to find empirical studies evaluating medical device regulation in the US or EU. We searched Medline using two nested...