EU – Switzerland MRA expired

The European Commission issued an article that announces the expiration of the EU-Switzerland Mutual Recognition Agreement (MRA). The article says:

“The Mutual Recognition Agreement (MRA) is one of the key agreements between the EU and Switzerland facilitating bilateral trade in a number of key sectors. It is essentially a “single market access” and “dynamic alignment” with EU rules agreement, two principles which are at the core of the Institutional Framework Agreement in negotiation with Switzerland since 2014.”

The European Commission

Switzerland has already aligned its regulatory system to the new medical devices regulations (MDR and IVDR).  Nonetheless, due to the current situation, Switzerland is treated as a third country. Swiss manufacturers thus need an EU Authorised Representative since May 26, 2021. Vice versa, manufacturers outside Switzerland who want to place their products on the Swiss market, need a Switzerland-based Authorised Representative. 

Source: European Commission

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