Swiss National Council Votes To Accept FDA Approved Medical Devices

By MedTech Intelligence Staff
November 29, 2022


• Categories: 05-Quality/Regulatory, MDR/IVDR, RC - EU MDR and IVDR, Regulatory

On November 28, the Swiss Parliament National Council voted to adapt its national laws, allowing Switzerland to accept medical devices with FDA approval. Since 2001, healthcare providers and patients in Switzerland have only had access to medical devices with an EU certificate. Swiss MedTech, an industry association, applauded the decision noting that, “It is essential that the order be implemented swiftly and pragmatically. Waiting cannot be an option if patient safety is at risk.”

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

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

In addition to challenges brought by new EU MDR, Switzerland has struggled to approve and introduce new devices due to its revised national medical device ordinance, which created even tougher import hurdles. Swiss Medtech reports that more than 1,000 of the approximately 5,000 foreign manufacturers have already stopped supplying Switzerland with their products.