Switzerland Approves Co-Authorisations with FDA Certifications
The Federal Council of our mountainous neighbours has approved a motion submitted by Swiss Medtech in 2021. The Müller motion, named after its initiator Damian Müller, CEO of Swiss Medtech, was discussed and approved by the Federal Council on 30 April. Concrete steps must now be taken to implement it.
What Will Be Changing on the Swiss Market?
The new co-authorisations are primarily a pragmatic step. Switzerland is responding to supply bottlenecks that have arisen since the the expiry of the Mutual Recognition Agreement (MRA) with the EU. More than 1,000 foreign manufacturers had withdrawn from the Swiss market in the meantime – a structural risk for basic medical care. Through cooperation with the US Food and Drug Administration (FDA), products, especially new innovations, could be made available more quickly in future, such as implants, diagnostic devices or digital tools that have long been on the market in the US, but have encountered bureaucratic resistance due to the more complex approval requirements of the MepV (Medizinproduktverordnung) (only in German).
But where there is light, there is also shadow: not all economic agents view the move uncritically. An expert report (only in German) commissioned by Swissmedic highlights significant differences in testing standards: Although the FDA works more quickly, it sometimes requires less extensive safety data. For Swissmedic, this means less control and more responsibility when reviewing FDA dossiers. The balance between security of supply and patient protection therefore remains delicate.
However, not only are US standards considered lower than European standards, there are also fundamental differences in the risk assessment of individual product groups. For example, a stair climber is classified as a Class I product in the EU, while the US FDA classifies stair climbers as Class II products. This entails different requirements, different testing standards and much more. Here, too, a case-by-case assessment by experts is necessary.
What Does This Entail for Manufacturers?
This presents a real strategic opportunity for manufacturers: those who already sell products approved in the United States can now secure access to the Swiss market relatively quickly through targeted preparation and smart documentation. But caution is advised – FDA approval does not replace a full evaluation by Swissmedic. Anyone who believes they can completely dispense with regulation is mistaken. Co-approval is a shortcut, not a free pass.
Does BEO BERLIN Join in?
As an expert in regulatory affairs in Switzerland, the EU and the US, BEO BERLIN knows the mechanisms and interfaces of these systems insode-out. Our longstanding partnerships especially with small and medium sized enterprises have provided us with a deep understanding of the regulatory processes inside and in between these different legal spaces. This expert knowledge makes BEO BERLIN an ideal partner on your way to a structured transfer of your FDA-documentation into the Swiss market.
Among other things we can:
- Evaluate FDA documentation with regard to Swiss requirements
- Provide strategic advice on how to use co-approval
- Communicate with Swissmedic, authorised representatives and review bodies
- Act as CH-REP for your company
Conclusion
By recognising FDA certifications, Switzerland is creating an alternative to the rigid MDR (Medical Device Regulation) system. As always, those who prepare professionally now will have a clear advantage.
BEO BERLIN is at your side – providing expert, strategic and reliable support. So that high-quality medical devices get to where they are needed.
Contact us for a non-binding enquiry.
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