Dec 13, 2019

Elections in the United Kingdom

The United Kingdom held general elections on December 12th, 2019, resulting in a significant majority for the Conservative Party lead by the current Prime Minister, Boris Johnson. His main campaign item was ”Get Brexit Done,” so now he can push forward in leading UK’s exit from the European Union (EU). Other parties have tried to campaign against this position, with the Liberal Democrats taking the clear position that they would revoke the Brexit process, while Labour and other parties taking a position between the Leave and remain extremes. Apparently the general opinion in the UK is that they should leave the EU.

Brexit

There is a draft withdrawal agreement between the UK and the  rest of the EU (‘EU27’) about how to leave and how to conduct negotiations for a trade agreement after that the withdrawal. Until that deal is closed, the UK will act as if it were still in the EU, but it will no longer be an EU Member State. Most likely the UK will leave the EU on January 31st, 2020. That day will have a high symbolic value, because not much will change in everyday life for UK and  EU citizens. There will be time to negotiate a trade deal until December 31st, 2020, which can be extended by a maximum of two years. Until another arrangement applies, the UK will pay to the EU budget, but it will not be part of any EU governing body. It is expected the draft withdrawal agreement will be voted on in UK Parliament before the end of 2019.

New agreement

Once the UK has left the EU, the two entities can start negotiating their new relationship. Although Boris Johnson has said before the 2016 Brexit referendum that such a deal would be the “easiest trade deal ever,” EU expectations are that such a deal will prove complex. The UK does not want to see their hands tight when negotiating with other markets. The EU wants to keep a level playing field for their industry, which means the UK must apply certain EU rules for their imports and industry. Apart from that, “free trade” does not mean “frictionless trade.” Free trade means there are no tariffs or quota, but border checks will still be required. That will cause friction not currently present between Member States of the Single Market. The border between Northern Ireland and the Irish Republic should be kept frictionless according to the Good Friday Peace Agreement, so there is a  very square peg in a very round hole that will require intensive honing to get solved.

No-deal Brexit

The no-deal Brexit is still an option. The negotiations between UK and EU may not result in an agreement ruling the relations between the UK and the EU. And even if there is an agreement, it is very likely the UK will be outside the jurisdiction of the EU. That means that the UK will probably end up as a “third county.” UK manufacturers may need an EU-based authorized representative and importer; EU27-based manufacturers may need similar arrangements in the UK; and non-EU manufacturers may need an EU27-based authorized representative and importer if they want to place their devices on the EU27 market. Logistics between both markets are likely to be more complex compared to the current situation.

Difficult negotiations

Where the elections campaign was dominated by one-liners, negotiating a future deal will be about details and the hard consequences of choices made. There is trade off between access to the EU27 and autonomy for the UK, and finding the right balance requires leaders taking political responsibilities and facing scrutiny. Boris Johnson insists he can get this new deal done in 11 months. But until that agreement is reached, a no-deal Brexit is still on the table. “Brexit is done” does not mean the clock has stopped ticking.

For the medical device and IVD industries, questions regarding applicability of the European Medical Devices Regulation (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR) in the UK, Notified Body partnerships, European versus UK in-country representation and related issues remain highly salient.

Learn more about EU and UK medical device and IVD regulatory issues: