Swiss move to secure flow of medical devices with EU

The medical device market in Switzerland employs some 58,000 people. © Keystone / Gaetan Bally

The Swiss government has been forced to introduce a transition period for the trade of medical devices with the EU, with a mutual recognition agreement set to expire on May 26.

The current agreement allows Switzerland to be a part of the European Union’s single market for medical devices – which includes everything from prosthetics to bandages – since 2001.

However, talks on extending the agreement have broken down due to delays on signing an overarching framework treaty on relations between the pair.

On Wednesday, the Swiss government said that Brussels made the extension of the medical devices agreement “dependent” on the outcome of the framework deal talks, which have been stalled now for a few years.

Without an updated deal, European products entering Switzerland will need to be stamped by an approved representative in Switzerland, the government said. It’s uncertain what the procedure will be for Swiss exports.

This would complicate the work of Swissmedic, which aims to ensure there are enough medical provisions in the country. It could also lead to headaches and extra costs for medical manufacturers.

As a stopgap measure, the government has created a transition period during which European devices can continue to enter the country as before. It didn’t specify how long this transition period will last.

The government hopes that an update of the mutual recognition agreement will be possible at a “later” date.

The stalled EU-Switzerland framework deal has been much debated in recent weeks, especially after a visit to Brussels this week by Swiss President Guy Parmelin didn’t lead to tangible progress.

Brussels has used mutual standards and market access as leverage with Switzerland in the past, including by suspending the equivalence of the Swiss stock market in 2019.