Switzerland to accept medical devices certified by the FDA

The Swiss parliament made an urgent and necessary decision paving the way for accepting medical devices certified by the FDA.

Switzerland flag

You know how every medical device needs to be approved before it is available to the general public or healthcare professionals? In Europe, the device must obtain the CE Mark, while in the U.S. – that is the job of the Federal Drug Administration, or short – the FDA.

So far, Switzerland relied on Europeans before launching a new medical device, but now – it has also voted to allow FDA-approved devices to be sold in the country.

The FDA process is faster and this decision would improve time to market in Switzerland, reducing dependence on Europe’s Notified Bodies for Swiss innovations to benefit Swiss patients.

As a result, Switzerland may become a launchpad for US medical devices entering Europe, keeping Swiss hospitals at the forefront of innovation.

“For more room for manoeuvre in the procurement of medical devices to supply of the Swiss population” instructs the Federal Council to adapt national laws so that (in addition to medical devices with an EU certificate / CE mark) medical devices with U.S. Food & Drug Administration (FDA) approval will now also be recognised in Switzerland.

“Swiss Medtech very much welcomes the policymakers’ important and forward-thinking decision,” says 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 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.”

“It is important that the motion is implemented quickly and pragmatically. There is no need for an elaborate enforcement apparatus, as is often reported,” added Sandra Rickenbacher, member of Swiss Medtech’s Management Board.

Examples such as Australia and Israel show it can be achieved in an uncomplicated manner. In these countries, efficient procedures to recognize FDA approvals in parallel with CE marked medical devices have proven successful.