Research by the Boston Consulting Group, published in January 2011, states that medical device recalls in Europe and the United States occur at similar rates while the approval process in Europe is significantly faster.

By analyzing publically available data on severe recalls of medical devices in Europe (equivalent to a Class I recall in the US) the study shows that the number of recalls in Europe is identical to that in the United States, and the therapeutic mix and type of recalls is also similar to that in the US.

The report states that this initial assessment of comparable recalls between the US and Europe does not suggest that different approval processes, and earlier approvals, in Europe come at a cost in terms of patient safety.

Read the complete report here