Swiss Medtech companies – action required for the sale of products in the EU as per May 2020 – Is your business ready for the upcoming changes?

1. The background in a nutshell

  • Until 25th May 2020 all Medtech products that are admitted in Switzerland for the sale can be distributed also in the EU.
  • However, currently a new treaty is negotiated by Switzerland and the EU Joint Committee in that regard.
  • In case the treaty is not going to be concluded between Switzerland and the EU, all Medtech companies based in Switzerland are considered as not being anymore part of the EU. Indeed this treaty hangs by a hair.

Following the latest developments of the Swiss-EU negotiations concerning the Institutional Agreement and the Mutual Recognition Agreement (MRA), Swiss Medtech companies should be preparing for the case in which MRA would no longer apply to the medical devices after 26th May 2020.

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