After Britain’s vote to withdraw from the European Union, medical device companies have been facing an uncertain future in the region.
Many of the changes will depend on just what extent the UK disconnects from the EU, according to a Nobles interview with MedEuronet co-founder Kristine Morrill.
If the UK exits fully, the country will leave the EU regulatory system, including the CE Mark system. This would mean separate approval processes would be required in both the EU and UK. This could mean the end to easy, seamless approvals across the region, as separate regulatory pathways would have to be sought, with separate clinical studies, according to the interview.
It could also spell out issues for American companies who work with the EU through notified bodies in the UK or Ireland, due to language commonalities, as they would no longer be able to operate through those venues.
Companies aren’t standing still, however, with the changes expected to take at least 2 years.
“If you want to get on the market in the UK, now is a really good time to do it because you still have the benefits of being in the EU,” Morrill told Nobles in an interview.
If companies are looking to avoid a possible sticky situation of entering the EU through a possibly-disconnected UK, Morrill said that Germany would be the easiest point of entry into the region.
But despite the questions in the air, most companies don’t seem to be sweating the Brexit as much as the medical device directive that’s slated to be instituted by the end of this year or early next year, Morrill said.
“I think that’s where most people have been putting their attention because that has a bigger impact. You can go to market in Europe without doing the UK. It’s not a make-or-break market today, by and large, unless you make the investment of getting a NICE recommendation, etc,” Morril told Nobles in an interview.