Navigating regulation in a post-Brexit era

It feels like a lifetime ago since the UK’s referendum on European Union (EU) membership in June 2016, with the UK exiting in January 2020. But what does that mean if you are looking to bring an innovative device to the UK market, and what steps do you need to take to ensure you are successful? Laura Friedl-Hirst dives into the essential strategies for innovators in the UK’s medical device industry

The MedTech industry is one of Europe's most diverse and innovative sectors. But it also operates within one of the most tightly regulated environments worldwide. Driven both by complex regulatory changes and the quest for innovation, the medical device industry landscape is changing, fast.

Today, the UK proudly boasts the third largest medical device market in Europe, and the sixth largest worldwide,1 with an impressive annual turnover of approximately $33 billion (over £26 billion) and the sector continues to experience rapid growth.2 Thanks to its single-provider, single-payer system, the UK remains a hugely a desirable market for medical device companies; however, it's also highly competitive.

As a result, bringing medical devices to market in the UK can be incredibly tricky. But navigating this vast, intricate terrain requires more than just innovation. Not only is the industry subject to significant scrutiny, but keeping pace with regulatory changes and ensuring ongoing compliance itself is a complex and demanding task, especially for smaller companies. Brexit has brought further complexities.

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