The UK’s exit from the European Union has left many questions regarding how the country will conduct business with other European countries. For the medical device industry, this question could lead to a massive increase in the cost of approving new devices.
For a medical device to be sold in the European Union, it needs two approvals: one from the EU, and one from a notified body. A notified body is a third party entity that has been granted authorization from the EU to assess medical devices and determine if a device meets the standards for approval.
Once a medical device has received both of these approvals, it can be sold and marketed in all the countries belonging to the European Union. This saves manufacturers from going through the approval process in each individual country. However, now that the UK has left the European Union, manufacturers are worried they will have to go through an additional approval process for distribution in the UK.
Manufacturers are also wondering if the notified bodies will still have the authority to approve devices for use in the UK. If not, who or what will assess and approve medical devices?
But the approval process isn’t the only uncertainty for medical device manufacturers. The European Medicines Agency (EMA) will no longer govern the safety of medications and medical devices for the UK. The EMA is similar to the United States’ Food and Drug Administration (FDA) and works to evaluate medical products. Without a governing agency to analyze reports of adverse events, medications and devices will go largely unchecked in the UK.
For pharmaceutical and device manufacturers in the UK, the regulations on how they will be governed are still completely up in the air. But it appears they won’t have any answers in the near future. Negotiations regarding the UK’s exit will take several years, and until then, the fate of the medical device industry in the UK and Europe will remain uncertain.