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The United Kingdom (UK) formally left the European Union (EU) on 31 January 2020 and became its own country, politically speaking. We're now in what is being called "the transition" - a period of 11 months where the UK is still bound by the EU's rules and must adhere to them. During this period, EU-UK negotiations will take place and decisions will be made to determine what the future of the relationship between these two parties will look like.
The main point on the agenda is how trade between the UK and EU will take place. Ideally, both parties will agree to a free trade deal in which the UK can continue to trade with the EU, with no tariffs or other barriers after the transition. There are three possible outcomes at the conclusion of the transition: 1) A free trade deal is agreed upon by both parties; 2) The UK leaves the transition with NO EU trade deal; 3) The transition is extended to continue negotiations.
What about the medical industry?
A question we get all the time from clients is how the changes from Brexit will affect medical regulations. Under the current system, there is a certain set of regulatory standards set forth by the European Commission. After the transition, the UK will have to come up with its own set of rules and regulations for putting medical products on the market. The registration systems are expected to double, at least for Medicines, Medical Devices, Food Supplements and Cosmetics. For example, a product may have its EU REACH certification, but now after the transition they may also have to get a UK REACH certification. This means double the effort and double the cost.
Companies in the UK who do not have any additional physical locations in other EU member states will also need an Authorized Representative (AR) after the transition - something they did not need when they were part of the EU. An AR is a legal entity designated by non European Union (EU) manufacturers, to represent them in the EU and ensure their compliance with the European Directives. If you want to learn more about what an AR is, read our blog post "Authorized Representatives - What You Need to Know".
The good news is that within the major negotiation of the free trade deal, it is widely expected that there will be a mutual recognition of the CE marking between the EU and UK. Let's raise a glass to that!
For more information on the Brexit timeline, check out this!--
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Do you need a UK representative medical devices (now called UK responsible person medical devices - UKRP)?
Do you know what is your medical device UK classification?
RQMIS experts consultants can help you with your medical device UK classification, acting as UK responsible person medical devices and providing guidance in the UKCA.