Europe has a more distributed approval system which has resulted in medical devices being approved and made available in Europe three to four years before these devices are approved in the US1. Even if Europe provides a faster route to market for medical device products, it has not affected their safety, i.e. there is little difference in the rates of serious recalls under the EU and U.S. regulatory systems.
Due to the longer approval process in the US, there has been a decline in the numbers of new devices developed only for the U.S. market. Between 2000 and 2007, 24% of all devices were intended for the U.S. only, i.e., devices for which no equivalent was ever approved in the EU. Since 2008, however, this proportion has fallen substantially, to only 15% between 2008 and 2011.
Did you know that an average of 77% of a medical device development budget is spent on an FDA approval in the US2?
Small device companies create most innovations while they also suffer the most with approval delays due to limited resources, and many are unable to withstand the costs of long regulatory delays1. In most cases, it is software that drives innovation in the medical device domain.
In order to help the small innovative software companies in the medical device domain we have developed software risk management and quality management system solutions as add-ons for Atlassian to fast-track regulatory compliance.
Let’s all benefit from the medical innovations sooner rather than later!
Read more about SoftComply Risk Manager
Read more about SoftComply eQMS