Blog: How do medical device recalls differ between the US, the UK and the EU?
By Patricia Anderson A medical device recall is action taken to remove or correct a problem with a device on the market because it contains some defect, poses some risk to users, or otherwise violates regulatory law. Naturally, manufacturers go to great lengths to prevent recalls from happening with all the research conducted before a device ever comes to market. However, you may wonder exactly how recalls work – both in the US and outside the US. While countries handle recalls differently, this article contains an overview of three examples of how countries handle recalls: recalls in the UK, the EU and the US. In the UK: Recalls in the UK are conducted and regulated by The Medicines and Healthcare products Regulatory Agency (MHRA), which is a government organization that was established in 2003. Prior to this, the MHRA existed as aspects of two separate organizations, Medicines Control Agency (MCA) and the Medical Devices Agency (MDA). The role of the MHRA in medical device...