Switzerland to Accept FDA Approved Medical Devices
Significant news announced on November 28th regarding Switzerland’s decision to accept FDA approved medical devices in parallel with CE marked product (under the new Medical Device Regulations). According to Peter Biedermann, Managing Director of Swiss Medtech, “it is a response to circumstances that could no longer be ignored… As innovations are increasingly being introduced first to the market in the USA, new products reach Europe with a delay, at best”. To date, Switzerland has seen approximately 1,000 out of the 5,000 foreign manufacturers pulling out of their market due to the increase difficulties with the new MDR process in conjunction with the tough importation hurdles. There is concern that patient safety is at risk due to limited product availability.
Opposition from the Swiss Federal Council has said the discrepancy between device classification under the FDA and MDR will cause administrative burden and that the situation should be re-evaluated at the end of 2024, which is the date (more specifically May 26, 2024) all devices must be certified directly under the new MDR process.
This motion was first brought to the Swiss parliament by Liberal Councilor Damian Müller in May 2020. It was approved by the Council of State on May 30, followed by approval from the Nation Council on November 28. Sandra Rickenbacher-Läuchli, legal counsel at Swiss Medtech, said that for now, the Swiss government has two years to implement the proposal which will be written by the responsible administrative bodies.
The Swiss Medtech Management Board has indicated the implementation of the motion should be streamlined, uncomplicated and quick. Following the lead of other counties, such as Australia and Israel, which already accept both FDA and CE marked medical devices.
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