Medical device recalls in the United Kingdom and European Union are at a 10-year high. At the same time, both regions are implementing reforms to strengthen medical device oversight and improve patient safety.
For full insights, please see Sedgwick European State of the Nation Index Report 2025.
The goal of these regulatory changes remains consistent: to protect patients. However, the path forward entails significantly increased obligations for manufacturers, importers and distributors. As reforms take shape, industry stakeholders continue to question whether the added burden strikes the right balance between safety and innovation.
With recall events rising in a changing regulatory environment, proactive engagement is key to managing risk. Here’s a closer look at the latest medical device recall trends across the EU and U.K.
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