Swiss Bring Device Regs in Line with EU Focus on Patient Safety
Switzerland is changing its medical device act, effective April 15, to bring it in line with EU regulations.
No change is expected for companies involved in the Swiss market as Swissmedic has already been voluntarily applying the EU rules, spokesman Peter Balzli says.
By renegotiating its mutual recognition agreement with the EU, Switzerland aims to cooperate more in market surveillance, says Erik Vollebregt, with Axon law firm in the Netherlands. The move is not surprising and creates a means for the country to keep up reforms under the European Commission’s joint action plan ().
The plan calls for increased surveillance of devices, and Swissmedic had identified notified bodies that issued CE-certificates outside their scope, Balzli says. As a result, two of five notified bodies in Switzerland have stopped issuing CE certificates for medical devices and a third will stop in a few months, leaving just two notified bodies in Switzerland, he says.
— Jonathon Shacat