Swiss Lawmakers Favor Adapting Regulations to Recognize FDA Approval of Medical Devices

November 28, 2022—Swiss Medtech announced that Switzerland’s Parliament issued instructions to the Federal Council to adapt national laws enabling the nation to accept medical devices with United States FDA approval for the welfare of its own population. Health care providers and patients in Switzerland have previously only had access to medical devices with a European Union (EU) certificate, noted the Swiss Medtech press release.

Swiss Medtech, which is the medical technology industry association in Switzerland representing > 750 members, stated that it welcomed this development to sustainably supply the Swiss population with quality-tested medical devices and advised that the order should be implemented swiftly and pragmatically.

The National Council conducted the final deliberation and acceptance of Councillor of States Damian Müller’s motion (20.3211), “For more room for maneuver in the procurement of medical devices to supply of the Swiss population,” which instructs the Federal Council to adapt national laws so that—in addition to medical devices with an EU certificate/CE Mark approval—medical devices with United States FDA approval will now also be recognized in Switzerland.

Peter Biedermann, Managing Director of Swiss Medtech, commented in the press release, “Swiss Medtech very much welcomes the policymakers’ important and forward-thinking decision. 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.”

Biederman continued, “As innovations are increasingly being introduced first to the market in the USA, new products reach Europe with a delay, at best.” In Switzerland, the situation is further aggravated by the revised national medical device ordinance with its even tougher import hurdles, added Swiss Medtech.

According to Swiss Medtech, > 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 affected, noted the press release.

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

The press release further stated, “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. The urgency to act is clear.”

“If patient safety suffers, waiting cannot be an option,” said the association lawyer responsible for the dossier.