Trade barrier for Swiss medical devices costs time and money

Due to the legal uncertainty in connection with the institutional agreement between Switzerland and the European Union, updating of the Mutual Recognition Agreement (MRA) is not ensured. However, an update of the MRA is a prerequisite for maintaining barrier-free access to the EU internal market.

What would happen if Swiss manufacturers could no longer bring their medical devices onto the market directly, but – like manufacturers of a third country – only by fulfilling additional requirements? Swiss Medtech interviewed manufacturers on this subject. The evaluation of the anonymous survey showed that, depending on the product range, manufacturers expect their products to be delayed for up to two years before receiving market approval. Overall, the average delay was one year. The industry expects an estimated cumulative decline in sales over the next three years of approximately 1 billion Swiss francs.

«This affects patients throughout Europe who do not have full access to Swiss medical devices», says Peter Studer, Head of Regulatory Affairs at Swiss Medtech. And adds «If Swiss manufacturers bring their products onto the market with delay, hospitals and doctors’ surgeries will turn to other suppliers in the EU area. Customer relationships are at risk. These long-term cost consequences for the Swiss medtech industry are not included in the estimate. They could be even more serious than the short-term consequences».