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.
Our experience with the Swiss medtech industry? Couldn’t be better.
Read more about the joint project of our colleagues from BAYOOMED and Ypsomed Holding AG for the mylife YpsoPump app.
„Qualitatively, the BAYOOMED employees are very well trained. Their understanding of processes and software development in the field of medical devices is also optimal.”
Bruno Anselmi, Senior Project Manager at Ypsomed AG
