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.
Continue reading Update: Mutual Recognition Agreement CH-EU
Swiss Medtech companies have recently engaged national associations in order to take action against the so-called SQS ban by the EU Commission.
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.
Continue reading Indirect Tax virtual round table
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.
Continue reading Trade obstacles for MedTech companies due to the failed negotiations on the EU-Switzerland Institutional Agreement
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
- 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
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.
Continue reading 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?