Certificates for Swiss devices issued by British notified bodies could be rendered void in the European Union post-Brexit.
“The European Commission was already warning in 2018 that in the event of a hard Brexit [Britain leaving the EU without a deal] certificates issued by the British notified bodiesexternal link could be cancelled,” Beat Egli, vice-president of Swiss Medtechexternal link, told the Swiss News Agency.
Around 40% of the medical products in circulation in the EU today have been certified by a British notified body.
“If these are no longer recognised in the event of a disorderly Brexit, the supply bottlenecks, which have already been created by stricter European standards, would get even worse,” said Andreas Balsiger, former legal advisor to Swissmedicexternal link, the Swiss Agency for Therapeutic Products.
Swiss Medtech does not have precise information on the proportion of certified Swiss products the other side of the English Channel, but it points out that some of its members have screened almost their entire range of products in accordance with British laws.
Beat Egli warned that the bilateral trade deal signed between Switzerland and Britain could not act as a “solid lifeline” for the exchange of medical devices between the two countries.
“Despite the agreement, unless we opt for expensive air transport between Zurich and London – instead of land transport – Swiss products could face the same bottlenecks at the British border as their European counterparts,” he said.
In the UK market Swiss exporters posted sales of around CHF300 million ($300 million) in 2017, compared with €5.6 billion (CHF6.3 billion) across the continent, according to the latest Swiss Medtech survey. The total global value of Swiss medtech exports reached CHF11.3 billion.