Update: Mutual Recognition Agreement CH-EU

1) General background information

As a consequence of the failed MRA between CH and the EU, EU certificates (i.e., medicinal products with SQS certificate) which were issued by the respective Swiss body, shall no longer be recognized in the EU and an EU representative is required.

Swiss Medtech companies have recently engaged national associations in order to take action against the so-called SQS ban by the EU Commission.

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Indirect Tax virtual round table

24 November 2021 or 25 November 2021

Dear Pharma and Life Science Colleagues,

Thank you for your interest in our virtual round table on ESG, regulation and rebates in the health industry. This event will be held online on Wednesday 24 November 2021 from 15:00 to 16:00 CET, and again on Thursday 25 November 2021 from 09:00 to 10:00 CET.

Using environmental, social and governance (ESG) metrics to evaluate companies and countries on their progress towards sustainability has become a hot topic all around the world. Alongside these issues, the health sector is also facing major regulatory challenges. 

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Trade obstacles for MedTech companies due to the failed negotiations on the EU-Switzerland Institutional Agreement

Switzerland and the EU did not reach a consensus on the negotiations of the Institutional Framework Agreement. As a consequence, the Mutual Recognition Agreement (MRA) between the EU and Switzerland and related provisions for medical devices were not updated and, therefore, ceased to apply on 26 May 2021. With that, as of now Switzerland is considered as a ‘third country’ and Swiss MedTech companies lost their previously barrier-free access to the EU market and vice versa. The following article shows what companies selling medical devices need to consider when exporting to the EU or Switzerland.

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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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