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Swiss NB numbers continue to fall

  • Posted by: inetika
  • Category: GLOBAL NEWS

Because of political disagreements between Switzerland and the EU with regard to bilateral access agreements, including that covering medical device regulation, there is uncertainty over the future of the Institutional Agreement (InstA) with the EU, and this has been making difficulties for Swiss device manufacturers and for the country’s two remaining notified bodies (down from seven, three years ago).

One Swiss Notified Body, SQS, has stated that they are not accepting any new customers, due to a lack of resources, while the other, QS Zurich, has announced it is going to cease its medical device activities.on 21 October 2019, saying following its MDR joint assessment by the designating authorities that it would take a “disproportionately high effort” to resolve the identified deviations.

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