Today the Swiss Federal Assembly (parliament) voted in favor of accepting medical devices with US FDA marketing authorization in Switzerland, citing concerns about product availability and the situation of the lapsed Mutual Recognition Agreement with the EU.

This was against the wishes of the Swiss Federal Council (the executive federal body), which cited the administrative strain of implementing this level of regulatory change, and patient safety concerns.

Background

The Mutual Recognition Agreement between Switzerland and the European Union has lapsed for medical devices and IVDs.

As a result, Switzerland has had to put various solutions in place to mitigate the potential shortage of medical devices. This includes continuing to recognize (and require) European CE Marking, plus the additional requirement to appoint a Swiss Authorized Representative.

However, the MDR/IVDR deadlines are approaching, and with them, more potential for a shortage of medical devices. Factors include:

• • Notified Bodies are backlogged, and many are not accepting new clients;
  • Manufacturers are preparing for a gap in supply as their MDR process is taking longer than they anticipated;
  • Some manufacturers are reducing their product catalogue for Europe, or even fully leaving the European market;
  • Some manufacturers are “waiting out” the MDR 2024 deadline, and will refocus on Europe after the worst of the transition activities are over;
  • Some manufacturers are opting for a US FDA first, then EU CE Marking approach.

As a result, the Swiss Parliament, and industry groups such as Swiss MedTech, have proposed also accepting products that have marketing authorization with the US Food and Drug Administration (FDA). In addition to the reasons already outlined above, Swiss MedTech notes that “More than 1,000 of the approximately 5,000 foreign manufacturers have already stopped supplying Switzerland with their products.”

The Swiss Federal Council is opposed to this and has recommended against the proposition. Reasons include:

• • The administrative burden of having to devise and implement a new regulatory system to allow US FDA products onto the market.
  • Patient safety concerns, due to the differences in risk classifications and review process between the US FDA and European Notified Bodies, i.e., they are not equivalent.
  • Swissmedic already has the legal ability to grant case-by-case exceptional authorizations if there are supply difficulties and therefore a mechanism already exists to address potential supply issues.

The potential acceptance of US FDA products was brought to vote in the 46-member Swiss Council of States on 30 May 2022, with 23 voting to accept and 12 voting to reject.

The Swiss Federal Council then issued a June 2022 Press Release (HERE) stating that there is no need accept non-CE Marked devices, such as US FDA devices, at this time. And that the Swiss Federal Council would reevaluate the situation at the end of 2024.

NOTE: the Swiss Council of States represents the cantons, which are the districts within Switzerland.

Today’s Vote

Today the motion was brought up for a vote in the 200-seat Swiss National Council. Although the Swiss Federal Council again urged against accepting US FDA products, the National Council sided with industry, with 100 votes to accept and 79 votes to reject.

With this, both chambers within the Swiss Parliament have voted to adopt the initiative.

The positions and final votes can be found: HERE

NOTE: the Swiss National Council represents the Swiss people. Together with the Swiss Council of States, they make up the Swiss Federal Assembly (parliament).

What next?

The Swiss Parliament has instructed the Swiss Federal Council to adapt legislation to allow devices with US FDA marketing approval onto the market.

Beyond that, the specifics are currently unknown. For example:

• • Whether all risk classes of devices will be accepted
  • What, if any, further assessment or review requirements will be placed on FDA versus CE Marked devices
  • When it will be put into place, and what kind of transition period will be implemented

The shift would be an enormous benefit to companies that have US FDA marketing authorization, but do not yet have CE Marking. They would potentially have another market open to them. Further, it benefits many companies that are concerned about MDD to MDR (or IVDD to IVDR) gap period.

Stay tuned for further details on this topic.

More information about Switzerland: Role of the Swiss Authorized Representative and Swiss Registration Requirements