Switzerland holds a prominent position in the European MedTech industry, boasting a substantial revenue of over 24 billion dollars as reported by Swiss Medtech, the association of Swiss medical technology, in 2022. Despite not being a part of the European Union (EU), Switzerland’s importance in the medical technology sector remains robust.
Since May 2021, the Mutual Recognition Agreement (MRA) with the EU is no longer applicable, posing potential challenges to the availability of medical products in the long term. To address this situation and avoid potential shortages of medical products, Switzerland has initiated the process of establishing mutual recognition agreements with other regions.
Swiss Regulations for Manufacturers
As part of the current Swiss regulations, manufacturers based outside of Switzerland, with the exception of Lichtenstein, are required to appoint an Authorized Representative (CH-REP) to introduce their products into the Swiss market. Switzerland has also made necessary amendments to its national regulation—previously in full alignment with the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Additionally, the country developed its own database, similar to the European database on medical devices (EUDAMED) system, to facilitate better management and monitoring of medical devices.
Switzerland’s Collaboration with the U.S.
In October 2022, the Swiss parliament voted in favor of accepting medical devices that have received marketing authorization from the U.S. Food and Drug Administration (FDA) in Switzerland. As a result, the Federal Council is currently in the process of adapting the legislation to enable the entry of devices approved by the FDA into the Swiss market.
An MRA between Switzerland and the U.S., specifically in the domain of Good Manufacturing Practice (GMP) for medicinal products, has come into effect from July 23, 2023. Under this agreement, both countries will mutually recognize and accept the inspections conducted by each other’s regulatory authorities.
On August 30, 2023, Swiss Medtech further supported this MRA by publishing a report indicating that medical devices approved by the FDA are equally as safe as CE-marked medical devices compliant with EU regulations.
In conclusion, Switzerland continues to be a major player in the MedTech industry, taking proactive measures to establish collaboration with other regions and ensure a steady supply of medical products within its borders.
How can NAMSA Help?
Navigating the global regulatory landscape can be overwhelming for any medical device manufacturer—not to mention very cost-intensive. That’s why having the right partner, at the right time, can be invaluable in achieving regulatory requirements, market success and accelerated timelines.
NAMSA is the industry leader in driving successful regulatory outcomes for medical device manufacturers. We provide a wide range of medical device and IVD regulatory consulting services across the full spectrum of product design and development through post-market support.
If you are interested in speaking with us about global regulatory strategies, please Contact Us, or learn more about our Regulatory experts at namsa.com/subject-matter-experts.
Sara Finocchietti, MEng, PhD
Sara Finocchietti has 15 years of experience in the medical device industry, having lived in multiple European countries and Japan. Her career started in public research developing innovative medical devices as well as providing clinical and regulatory strategy for market access in Europe. Her previous experiences include working as a Clinical Affairs Manager at a French manufacturer with a full orthopedic portfolio, defining the strategy to transition to the EU's Medical Device Regulation (MDR). Sara has a keen interest in new technologies and innovation. She has extensive experience working within cross-functional and cross-cultural teams.