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.

Continue reading Update: Mutual Recognition Agreement CH-EU

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. 

Continue reading Indirect Tax virtual round table

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.

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

Great news for Swiss Medtech companies – Postponement of the application date of MDR

In one of our previous posts we draw your attention to the upcoming deadline of May 26th, 2020 which was the date on which the MDR, i.e. the new EU regulation concerning medical devices was expected to be fully applicable.

Continue reading Great news for Swiss Medtech companies – Postponement of the application date of MDR