In April, the UK received a six-month extension to Brexit, in hopes that members of parliament will be able to decide on a withdrawal agreement. All this before the extended deadline of October 31st, 2019. With the British Conservative Party announcing its new leader Boris Johnson, speculation of a no-deal scenario have arose. Johnson has publicly promised to take the UK out of the European Union, “do or die”, by October 31st. In this no-deal scenario, the UK immediately leaves the European Union. What does this Brexit scenario mean for medical device companies?
The no-deal scenario
If the UK leaves without an agreement, it results in an end to the UK’s current participation in the European regulatory network for medical devices. The MHRA is the UK’s national regulator for human medicines, so they would take over for the UK market. Then, in the remaining time period, all manufactures of medical devices in the UK are required to place a CE mark on their products. After all, these UK medical devices are still subject to EU legislation. However, if there is no deal after October 31st, UK-based Notified Bodies will no longer be recognized by the EU. Hence, the certified devices will no longer be eligible for the EU market. If this happens, the UK government will give them an ongoing legal status and continually recognize the certificates issued prior to October 31, 2019. This will ensure the products covered by certificates issued by UK-based Notified Bodies will still be placed on the UK market after the deadline. This in turn ensures a steady supply. In this case, the labeling of affected products will not need to be changed. The UK will also continue to recognize existing clinical investigation approvals with no need for re-applying.
While uncertainty remains about the effects of Brexit on the medical device industry, we aim to give our clients as much certainty as possible. If you are stuck with questions about Brexit you can reach Emre Aykac, VP Healthcare at firstname.lastname@example.org. With our Sales Outsourcing and Digital Marketing services, we can still help you get the presence you need in Europe, even in the case of a no-deal Brexit. To stay up to date, also have a look at UK government websites and international bodies’ publications.