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Signs Of Hope But Obstacles Remain For Swiss Device MRA With EU

 
• By Ashley Yeo

Without the MRA that allows unimpeded bilateral device trade between the EU and Switzerland, Swiss industry is having to find ways of limiting the damage that newly erected barriers will cause after the MDR comes into force.

Transition sign

“We don’t want special treatment, just that Swiss products are treated the same as those from any other third country to the EU.” So said Swiss Medtech regulatory head Daniel Delfosse, who fears that EU market access will be made much more difficult, if not impossible for some local companies, after the Medical Device Regulation comes into force in the EU on 26 May.

The ongoing failure of two parties to renew the mutual recognition agreement (MRA) to take account of the new medtech regulatory conditions that the MDR enforces will lead to blocked...

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