What impact does Brexit have on CE certification?

The United Kingdom wants to go by the EU Say, then the question is, for the medical device industry , what impact will the Brexit have on CE certificates, UK-based notified bodies such as BSI and authorized representatives in the UK? Dr. Chao Xu, the deputy general manager of Austin, will give you an exclusive interpretation in the first time.

First of all, Dr. Chao Xu interprets several important concepts for everyone.

EU: European Union, a political and economic alliance established under the Maastricht Treaty (also known as the Treaty of the European Union), which came into force in 1993, now has 28 member states.

The United Kingdom has just decided to leave the European Union through a referendum, but has not officially left the EU. Even if it is officially withdrawn, it will be until 2018.

The European Economic Area (EEA) came into force on January 1, 1994, after the European Free Trade Association (EFTA) reached an agreement with the European Union (EU), with the aim of allowing the members of the European Free Trade Association to participate in Europe without joining the European Union. Single market.

The UK is a member of the EEA. Even if it leaves the EU, it does not mean that the UK will leave the EEA and continue to enjoy the free trade agreement, that is, the freedom of circulation between products between the UK and the EEA countries, but will face higher non-tariff barriers.

The Schengen Convention is a treaty agreement between European countries whose purpose is to eliminate border checkpoints between them and to coordinate border controls outside the Schengen area. That is, in the case of the cancellation of border control between member states, a person holding a valid ID card or a Schengen visa for any member state can move freely within the territory of all member states. According to the agreement, tourists can legally visit all other Schengen countries if they hold a tourist visa for one of them.

Britain has never joined the Schengen Convention. This is why, when traveling to Europe, after obtaining a Schengen visa, you can travel to Switzerland, but you cannot travel to the UK.

Eurozone: Eurozone, a currency union of 19 of the 28 European Union member states. These countries use the euro (€) as their common currency and the only one. The other nine EU member states use their own currency.

Britain does not belong to the euro zone

Below, Dr. Chao Xu explains in detail the impact of Brexit on CE certificates, UK-based notified bodies such as BSI and authorized representatives in the UK.

For the medical device industry, in fact, we use Switzerland as an example, it is easy to understand what the future situation in the UK may be.

What impact does Brexit have on CE certification?

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