Almost one year ago, Swiss Parliament voted to allow FDA products onto the Swiss market. Swiss Parliament then instructed the Swiss Federal Council to adapt the legislation accordingly. More on that is available: HERE

As of today, FDA devices are still not allowed on the Swiss market.

Swiss Medtech presented legal justifications as to why allowance of FDA devices should not be delayed. They commissioned two position papers to address 1) the safety of US FDA devices as compared to EU CE Marked devices and 2) whether the amendments must be made on the Federal level, or if they can be made on the ordinance level.

Swiss Medtech’s update

Swiss MedTech is working in the best interests of its members – advocating for more, and easier market access.

Yesterday they published two updates.

Patient Safety

One of the concerns posed by the Swiss Federal Council was related to safety. Specifically, if US FDA devices would present the same level of safety as CE Marked devices.

Swiss Medtech commissioned a 48-page report to evaluate medical device safety between the US and Europe. The report (available here, in German) concludes that no overall safety concerns were found.

The report asserts (below are informal translations into English):

“Both systems have individual challenging elements but seem to but seem to work well overall. In both regulatory systems, the safety and performance of the products, as well as their monitoring, is of central importance.”

“Overall, no significant safety concerns could be identified. Medical devices from both jurisdictions are developed, manufactured, and monitored according to comparably high requirements. Based on this system comparison, medical devices approved by the FDA for the U.S. are at least as safe as CE-marked medical devices that meet the regulations of the EU.”

The report also included the following caveat:

“It should be noted, however, that the regulatory systems in this report were compared across the board and not for individual products. Therefore, it cannot be concluded across the board that there are no differences for individual products. This must be considered separately be considered separately.”

Amendment to Legislation

Swiss Medtech also commissioned a 34-page legal assessment (available here, in German) regarding legislation amendments. Specifically: What legal amendments are required in order to allow FDA devices onto the Swiss market, on an equal basis as CE Marked devices?

The legal assessment concludes that there is no need to amend the overarching Federal level Therapeutic Products Act. Instead, revision at the ordinance level (i.e., Medical Device Ordinance (MedDO)) would be sufficient from a legal standpoint.   

Notes

Swiss Medtech is working hard to address the Swiss Federal Council’s areas of concern, and to drive the initiative forward. They have pointed out lack of device variety in hospitals and the barrier to innovation. That said, industry is still waiting for the Swiss Federal Council to initiate next steps.

Further, the initiative is not a ‘free-for-all’ for FDA devices. Those devices would still be subject to certain Swiss requirements, such as labeling, vigilance, post-market surveillance, and appointment of a Swiss Authorized Representative. However, it would allow devices with FDA marketing authorization to be placed onto the market on a similar basis as CE Marked medical devices.

Stay tuned for more updates. Casus will be reporting as new information becomes available.