Patients in Switzerland should be able to benefit from internationally recognised medical devices. Swiss Medtech welcomes this decision, which will ensure security of supply and support for domestic innovation
Currently, Switzerland only authorises medical devices that comply with European regulations. As a result, many highly innovative products (including some developed domestically) that have long been established in the USA are denied access to the Swiss market. This unfortunate situation will now be corrected: in the future, Swiss patients will be able to benefit from FDA-approved products – including state-of-the-art heart valves, joint implants, and robot-assisted surgical systems.
«Many products developed and produced in Switzerland remain unavailable to Swiss patients due to regulatory hurdles – it’s an absurd situation,» explains Damian Müller, President of Swiss Medtech and author of the parliamentary mandate submitted to the Federal Council in November 2021. «This is about to change: these premium quality, safety tested, and Swiss-made innovations will finally be approved for our healthcare system,» says the delighted Councillor of States Damian Müller.
The Federal Council has provided the competent authorities with clear guidelines for implementation: a simplified conformity procedure and the commissioning of private bodies. This will align the implementation procedures with the European system. Swiss Medtech expressly welcomes these directives. «The FDA is a globally recognised regulatory authority with decades of experience. Products considered safe in the USA also meet the highest quality and safety requirements for Switzerland,» emphasises Adrian Hunn, Director of Swiss Medtech. «A streamlined procedure is completely sufficient – we cannot afford to waste time on new bureaucratic hurdles».
Secure supply – promote innovation – strengthen business location
Damian Müller continues: «Our persistent advocacy has now paid off. The Federal Council is sending a clear message in favour of safe, modern patient care, encouraging innovation, and promoting the Swiss medtech industry as a world leader». Speed is of the essence: «Legal implementation must be swift and pragmatic in view of the increasing shortages in hospitals, doctors’ surgeries, and healthcare facilities. When patient safety is at risk, there is no time to waste. Rapid implementation at the ordinance level is not only possible, but absolutely essential».
Swiss Medtech is committed and engaged – also in the implementation phase
«Our goal is clear: patients in Switzerland must have prompt and reliable access to the best medical devices in the world. At the same time, our goal is to ensure that the Swiss medtech business location is strengthened and that innovation products continue to be developed, produced, and authorised within our borders,» explains Damian Müller.
The implementation phase has begun – it is now time to work out the details. «We will continue to cooperate closely and constructively with the authorities to ensure that any legal adjustments are pragmatic, efficient, and in the interests of both patients and the industry. And we will strive resolutely in favour of a swift adoption via ordinance», concludes Adrian Hunn.
Swiss Medtech represents around 800 members in its role as industry association for Swiss medical technology. With 71,700 employees and a contribution of 11.9% to the positive trade balance, medical technology is an economically significant sector in Switzerland. Swiss Medtech advocates for conditions that enable the medtech industry to perform at peak capacity and provide first-class medical care.