On 29 March 2017, the UK government served formal notice under Article 50 of The Treaty on European Union to terminate the UK's membership of the EU (following the June 2016 UK referendum on EU membership). Based on Article 50, the EU Treaties shall cease to apply to the UK and the UK exit will take effect in March 2019 (subject to the unlikely possibility of the withdrawal agreement being concluded sooner and unless all Member States agree to extend the period). Negotiation of a new trade agreement with the EU could take several years beyond 2019 although the Prime Minister has declared the objective of achieving such an agreement within the two-year period.
What is the immediate effect of the Brexit Vote
As the UK will remain within the EU until 29 March 2019, 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