In September 2024, Swiss MedTech released its new sector study for 2024, highlighting the significant impact of the Swiss medical technology sector on the country’s economy. Based on a survey conducted among 470 medtech companies located in Switzerland, the report provides an overview of the Swiss medical technology sector, while emphasizing its challenges and opportunities. Regarding regulatory aspects, the report argues that Swiss medtech companies view the rising hurdles for market authorisation under the EU Medical Devices Regulations (MDR and IVDR) as a significant challenge, particularly increasing pressure on smaller firms.
Introduction of MDR and IVDR and their implementation at Swiss level
According to the survey conducted by Swiss MedTech, different actors agree that the growing requirements for market approval in Europe are considered the industry’s biggest challenge, although companies have now a better understanding of these regulations’ impact on their business activities.
The report highlights the legal uncertainty surrounding these new regulations. Based on their survey results, the limited availability of reliable information, the shortage of notified bodies, and the financial burden associated with the increased regulatory workload are considered to be the main challenges. Although the monetary pressure has decreased in the last two years, it still remains high.
Certification procedure under EU Medical Devices Regulations
Interestingly, the report shows that over 90% of Swiss medtech manufacturers certify their products according to EU conformity assessment paths. Moreover, about half of them certify their products exclusively according to EU regulations. Nonetheless, product costs and price of medical devices have increased as a result of the MDR and IVDR implementation.
In conclusion, the report showcases that companies are still having difficulties adapting to the new European legislation regarding medical devices. Theses complexities have undermined the innovation efforts of Swiss companies as well as Europe’s overall position as a hub for innovation. Consequently, companies tend to shift towards the US FDA system rather than the European MDR/IVDR system as it is less expensive and quicker, Swiss MedTech underlines.
Do you have questions on how to place your medical devices on the Swiss market? Contact us today.
Meric Gonul
Regulatory Intelligence & Innovation
24/09/2024
Reference:
- Swiss MedTech (2024) Swiss Medical Technology Industry Sector Study 2024. Retrieved on 23.09.2024.
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