Consequences for the medtech industry

No agreement between Switzerland and the EU

It has burst. The new agreement between Switzerland and the EU will not enter into force. After seven years of negotiations between representatives of the EU Commission and Switzerland, President Guy Parmelin declared the talks a failure yesterday. The reason, he said, was disagreement on crucial points of the negotiations, such as access to the EU’s internal market and agreements on the free movement of persons. The modernisation of the agreement, which has been in place since 1972, has thus failed to materialise.

A failure that particularly affects the Swiss medtech sector shortly after the transition to the new MDR 2017/745. What does this mean for access to the EU internal market?

Due to the loss of privileged access, Switzerland will now be downgraded to the status of a third country. Manufacturers must therefore adapt when placing new medical devices on the European market.

The consequences are additional work due to increased requirements and having to go through the European approval process. In addition to the designation of a specific Notified Body, the preparation of corresponding technical documentation is also required.

Are you affected by the collapsed agreement?

We support you. As experts in regulatory affairs, approval requirements and post-market surveillance, we are familiar with the applicable standards in the EU.

In addition to the compliant development of medical devices, we guarantee the approval of your medical device on the European market.

And: Our colleagues at BAYOOCARE bring your existing product onto the market – and return it to you as soon as you have adapted and certified your own processes and companies in accordance with the MDR guidelines. This way, you can continue to remain on the market with your products and take care of the analysis and implementation of the requirements.

You don’t know what you need to adapt for the MDR? No problem! Our BAYOOMED experts analyse your existing processes and develop pragmatic solutions to close gaps.

Learn more and feel free to contact us.

Our personal experience with the Swiss medtech industry? Couldn’t be better. Read more about our joint project with Ypsomed Holding AG for the mylife YpsoPump app.

Quality of life per app – Remote control for the mylife YpsoPump

26. April 2021/0 Comments/by Annika Pörner

With the vision of making self-treatment a matter of course, the Swiss company Ypsomed Holding AG successfully develops injection and infusion systems for the international market. What began more than 30 years ago in Burgdorf (Switzerland) with the development of the first innovative insulin pump continues to be an important focus of Ypsomed’s expertise today.

No agreement between Switzerland and the EU

Are you affected by the collapsed agreement?

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