Important Swiss deadline for Class I Medical Devices, System and Procedure packs -- MEDICA - World Forum for Medicine

11.08.2022

Obelis SA OBELIS GROUP

Important Swiss deadline for Class I Medical Devices, System and Procedure packs

On 31 July 2022, non-Swiss manufacturers established in the EU/EEA or with an EU/EEA Authorized Representative should designate a Swiss Authorized Representative for class I medical devices, systems and procedure packs.

In addition, we would like to remind you that the following important deadlines apply to other classes of devices:

For MDD/AIMDD and MDR devices:
  • By 31 December 2021 for class III devices, class IIb implantable devices, and all active implantable devices (AIMD)
  • By 31 March 2022 for non-implantable class IIb devices and class IIa devices
For IVDD and IVDR devices:
  • By 31 December 2022 for class D
  • By 31 March 2023 for class C and class B
  • By 31 July 2023 for class A
If you have not designated an EU Authorized Representative, you must appoint a Swiss Authorized Representative from 26 May 2021 (for MDD/AIMDD and MDR devices) and from 26 May 2022 (for IVDD and IVDR devices).

Contact us today to appoint Obelis as your Swiss Authorized Representative!


Exhibitor Data Sheet