Keyword Analysis & Research: switzerland mdr

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Frequently Asked Questions

What is Switzerland’s position under the Medical Device Regulation MDR (EU)?

Since 26 May 2021, with the full application of the Medical Device Regulation MDR (EU) 2017/745 and in the absence of an institutional agreement reached, Switzerland is officially considered a “Third Country” for Europe. This means that Swiss Manufacturers must appoint a European Authorised Representative to export their devices to Europe.

Is the MDR MRA in place in Switzerland?

The current Medical Device Directives are covered by such agreements, but the MRA for the MDR can only be signed if there is an agreement on the bigger treaty. This may take a while. At this moment the Swiss Competent Authority Swissmedic does not communicate anything about the consequences of not having the MDR MRA in place.

How has Swissmedic adapted to the new EU MDR?

As part of the alignment of Swiss medical devices legislation to the new EU MDR, Swissmedic has already implemented the following changes: As of 1 May 2021, applications for clinical trials of medical devices are already being processed according to the new law.

Will Switzerland become a third country for the implementation of MDR?

Without an updated MRA having been produced by the MDR deadline last week (26th May 2021), Switzerland has now become a third country for the purposes of the implementation of the MDR. Our CEO Jörg Dogwiler delves deeper into how this will impact medical devices trade between Switzerland and the European Union…

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