The Swiss Federal Assembly has voted in favour of accepting medical devices with US Food and Drug Administration (FDA) marketing authorisation in Switzerland.
A motion for ‘more freedom of action in the procurement of medical products for supply of the Swiss population’ was discussed and put to a vote in the country’s parliament on Monday 28 November, with many industry groups, including Swiss Medtech, supporting the acceptance of FDA-approved devices.
In a press release, Swiss Medtech described this as a “necessary and urgently needed decision”, and stated that it is “essential” for this order to now be implemented swiftly and pragmatically. It further draws on Australia and Israel as examples of countries in which “efficient procedures” to recognise FDA approvals in parallel with the CE mark have “proven successful”, and “can be achieved in an uncomplicated manner”.
“Swiss Medtech very much welcomes the policymakers’ important and forward-thinking decision,” added Peter Biedermann, managing director of Swiss Medtech. “It is a response to circumstances that could no longer be ignored. Specifically, problems with the implementation of the new European Medical Device Regulation [MDR], and the negative consequences concerning availability, product range and quality of medical devices throughout Europe. As innovations are increasingly being introduced first to the market in the USA, new products reach Europe with a delay, at best.”
The Swiss Federal Council—the executive body of the country’s federal government—opposed this proposition, citing the administrative burden that would be brought about by this regulatory shift, and patient safety concerns caused by risk classification discrepancies between the USA and Europe.
On 30 May 2022, the potential acceptance of US FDA products was voted on by the 46 members of the Swiss Council of States (the upper house of the country’s Federal Assembly), with 23 voting to accept and 12 voting to reject.
Shortly following this decision, the Federal Council asserted in a press release that there was no need to accept non-CE-marked medical devices, such as US FDA-approved devices, at that time—describing the extension of simplified market access to other countries outside of the EU as “disproportionate”—before noting that it would re-evaluate this situation at the end of 2024. It added that the supply of safe medical devices in Switzerland was “currently guaranteed”, referencing various backup measures it took back in 2021 to ensure this “even without an updated MRA [Mutual Recognition Agreement]”.
The parliamentary vote that took place earlier this week was borne out of the introduction of the European MDR on 26 May 2021, with the MRA and all related trade-facilitating effects for medical devices between the EU and Switzerland also ceasing to apply from the same date.
And, while devices ‘in conformity’ with the MDR can be certified and placed on the market until 25 May 2024, marketed devices must be certified directly under the MDR from the following day (26 May) onwards. With this deadline drawing ever closer, concerns have been raised regarding regulatory challenges, supply chain gaps and device shortages, and the impact this could have on patient care and industry alike.
As a statement from Swiss Medtech notes, “more than 1,000 of the approximately 5,000 foreign manufacturers have already stopped supplying Switzerland with their products—they are not prepared to meet the additional requirements for the limited Swiss market, and patients in Switzerland are the ones to suffer”.
The motion to accept US FDA approval of devices in Switzerland was brought up to the 200-seat Swiss National Council (the lower house of the country’s Federal Assembly) on Monday, with 100 votes in favour and 79 against being cast. As such, both chambers of Switzerland’s national parliament have now voted to adopt the initiative, and will instruct the Swiss Federal Council to adapt legislation to allow devices with US FDA clearance onto the market.
Details of this new system and the logistics of implementing it, as well as when it will come into effect, are yet to be confirmed.