Parliament wants Switzerland to accept FDA approvals of medical devices

The National Council’s final deliberation and acceptance of Councillor of States Damian Müller’s motion (20.3211) «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  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,» says Biedermann. 

Role models Israel and Australia

The Federal Council will now draw up a corresponding draft. After the consultation process, it will be revised and finally submitted to parliament again.

«It is important that the motion is implemented quickly and pragmatically. There is no need for an elaborate enforcement apparatus, as is often reported,» says 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 recognise FDA approvals in parallel with CE marked medical devices have proven successful. 

(Press release / SK)
Bild: Eidgenössische Parlamentsdienste, Bern