Bern – Given the circumstances, the Swiss industry is in a good position when it comes to exporting medical devices, but the situation with imports is alarming: this was the assessment made by the Swiss Medtech industry association at this year’s conference, which was all about third-country status.
According to a press release by Swiss Medtech, the industry largely anticipated the third-country scenario and spent two years preparing to meet the additional requirements for the seamless export of its goods to the EU. While the situation is clear for MDR products, there is still legal uncertainty with regard to medical devices with existing MDD certificates.
With the entry into force of the national Medical Devices Ordinance (MepV) on May 26, the Federal Council set high import hurdles for foreign manufacturers. In doing so, Switzerland is not only harming the domestic medtech industry, but is also endangering "the health care of its own population," according to Swiss Medtech. Industry surveys showed that one in eight of the medical devices used in Switzerland today will no longer be available in the future. “We are currently aware of individual examples of delivery stops. From the second half of next year, there will be widespread gaps in supply," says Dr. Daniel Delfosse, Head of Regulatory Affairs at Swiss Medtech, quoted. With the MepV, Switzerland has further tightened the law adopted by the EU (MDR) (Swiss Finish). "The template doesn't work in reality. We demand an urgent change. With a few adjustments to the ordinance, the looming supply problem could be massively defused. The Swiss government has that alone in their hands,” said Delfosse.
The full press release can be found at this link .
