The UK recently voted to leave the European Union in an advisory referendum. The impact of Brexit on medical devices regulation in the medium-to-long term will very much depend on the form a post-Brexit UK will take, the relationship that the UK chooses to have with the EU, and indeed the relationship that the EU is willing to accept. That will not become clear for some time as it will likely take at least two years for the UK to negotiate an exit from the EU from the point when the UK notifies the EU of its intention to leave, which will not be until October 2016 at the earliest. In the short-term, however, from a legal perspective it is likely to be business as usual for the medical devices industry since EU law will continue to apply in the UK. Nevertheless, medical devices companies need to start considering what steps they should take to minimise impact and disruption if and when Brexit happens.