Brexit and medical devices: what will change?
On June 23 UK voters decided to leave European Union and because of this many medical devices companies are wondering how Brexit will affect the regulation of devices and IVDs sold in the country.
The MHRA (Medicines and Healthcare Products and Regulatory Agency) issued a statement in which they say that they will keep doing their work as usual because until the final breakup, British regulations remain aligned with European rules and CE marked products can move freely.
When the exit is definitive, the consequences regarding medical devices market can be different. It will be a free movement of goods under the CE marking (like Switzerland or Norway). Another possibility will be to make a mutual recognition agreement for medical devices according which only CE marked devices will be distributed in the UK. It will be likely a trade with Europe under special agreement that helps manufactures placing devices on the market. Another option, but less probable than others, will be to trade with Europe under the general World Trade Organization Arrangement, which means extra work and cost.
The UK is highly dependent on medical devices imports and because of this, the MHRA and the government are going to make many efforts to ensure the flow of vital medical technologies.