New EU medical device regulations cause industry shake up
Medical device manufacturers will need to provide substantially more clinical evidence to support claims of safety and performance for many medical and in vitro diagnostic (IVD) devices marketed in the European Union (EU) as the result of two new regulations adopted by the European Parliament. The reforms, which are among the most far-reaching changes to affect the industry in recent years, were developed to harmonize regulatory requirements across Europe and improve patient safety.
High costs and recruitment issues drive the globalization of clinical trials
The pursuit of global trials is increasing. A report by SCORR Marketing and Applied Clinical Trials examined the reasons why companies are pursuing global clinical trials and the challenges they face in conducting them. The top two reasons cited in the survey for trials exiting the U.S. and Western Europe and moving to other regions were high costs and patient recruitment difficulty.
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