The healthcare arm of the U.K. government provided further guidance last Friday on how a "no deal" Brexit will affect the medtech sector.
With the U.K government set to vote next week on a largely opposed deal crafted between Prime Minister Theresa May and the EU, the government is stepping up its preparations for the prospect of the country crashing out of the European Union in March.
If that happens, medtech companies will need to have a designated individual based in the U.K. to register a product in the country and otherwise adapt to the new regulatory landscape.
If, as looks possible, most politicians vote against the EU-May deal, the U.K. will face the prospect of leaving the EU without a deal at the end of March. In that scenario the regulatory regimes in the U.K. and EU would split overnight, ending years of ever-closer integration.
The U.K. government began 2019 by publishing a document outlining how that overnight split would affect medical device companies. The document builds on statements the government released last year to help the industry prepare for a no-deal Brexit.
Many of the actions proposed by the government are intended to limit the impact of a no-deal exit on the industry but companies will be forced to make some changes. For example, companies that lack a base in the U.K. will need to hire a designated representative in the country before registering a device for sale. Currently, companies can use a responsible person based elsewhere in the EU.
The U.K. plans to give companies some time to put the resources required for registration in place. In theory, all medical devices will need to be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) to be sold in the U.K. after Brexit. In practice, MHRA will give companies four to 12 months to comply with the registration process, depending on the risk level of a device.
Other sections of the text address the conformity of products, clinical trials, post-market surveillance and the transposing of incoming EU medical device regulations into U.K. law.
The preparatory steps outlined in the document could be rendered irrelevant by upcoming events. If the U.K. government wins the upcoming vote on the withdrawal agreement, a transition period will start at the end of March that maintains something approaching the status quo until the start of 2021. Alternatively, a vote against the deal could cause the U.K. to try to delay its split from the U.K.