This should put a spring in your step as you begin the work week: the United States and Europe report roughly the same number of severe medical device recalls, yet the approval process in Europe is significantly faster. A report from the Boston Consulting Group (BCG) posted on the Eucomed website shows that decentralised oversight in Europe—the essence of the New Approach regulatory system—allows people to benefit from innovative new products without jeopardising patient safety. The findings of the BCG report are in line with an earlier report by US medtech entrepreneur Josh Makower, which noted that patients in Europe get access to new therapies an average of two years before patients in the United States because of regulatory challenges at US FDA.
Something to keep in mind as the recast of the medical device directives moves forward . . . .
Read the full press release, “EU regulatory system brings Europeans fastest access to medical technology without compromising safety,” the BCG report, and the Makower study on the Eucomed website.Norbert Sparrow