For which Medical Devices is it necessary to appoint a Swiss Authorised Representative?

The designation of the Swiss Authorised Representative (CH REP) is required to market all Medical Devices, including legacy devices, i.e. devices covered by a certificate still valid in compliance with the MDD / AIMDD Directives and class I devices that will require the intervention of a Notified Body (ON) which can continue to be made available on the market or put into service until May 27, 2025.

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