On 23 June 2016, the UK public voted to leave the European Union ("Brexit"). The Prime Minister subsequently announced an intention to serve notice of withdrawal under Article 50 of the Treaty on European Union by the end of March 2017. Based on Article 50, the EU Treaties shall cease to apply to the UK:
- from the date of entry into force of the withdrawal agreement that the UK negotiates with the Union, acting through the Council; or
- two years after the UK has notified the European Council of its intention to withdraw, unless the European Council, in agreement with the UK, unanimously decides to extend this period.
Therefore, in practice the Brexit date is most unlikely to be before March 2019.
What is the immediate effect of the Brexit Vote
As the UK will remain within the EU for at least the next 2 years, in the short term the answer is that it should be "business as usual" for the medical devices sector in the UK. Furthermore, for now at least, the UK is a full voting member of the European Committee for Standardisation (CEN), which is unlikely to change, no matter what the UK’s new relationship with the EU looks like.
The decision as to which model will be adopted by the UK and the EU post-Brexit will determine how the medical devices sector is truly affected. Initially, it seemed likely that the UK would remain within the European Economic Area (EEA), and the effects would likely to have been minimal on the sector, as the UK would keep access to many of the benefits of the EU system; this now is politically unlikely. Similarly, if the UK joins the European Free Trade Association (EFTA) and negotiates sector specific access to the single market, then, depending on the exact nature of the relationship, effects may again be limited and there would be little or no impact on UK’s regulatory approval of medical devices.
If, however, the UK choses to move further away from the EU (as seems most likely given recent pronouncements) and decides to leave the CEN, or cannot agree the terms of a continued close association with the EU, then the effects may be more severe. The most likely scenario is that it would establish a UK-based regulatory system that unilaterally recognizes CE Mark certification as evidence on which to grant approval.
This article is part of our Brexit series